Venous Leg Ulcer, Venous Stasis Ulcers
Conditions
Keywords
Venous Leg Ulcer (VLU), Venous Stasis Ulcer (VSU), VLU, VSU, Leg Ulcer, Leg Wound
Brief summary
This is a 16-week study for subjects with a venous leg ulcer between the knee and ankle. This research is being done to determine the effectiveness of two dosing frequencies and two different concentrations of HP802-247, together with standard care, compared to placebo, plus standard care.
Interventions
BIOLOGICALHP802-247
One dose of HP802-247 consists of 260 microliters (uL) containing keratinocytes and fibroblasts totaling 0.5 x 10-6 power or 5.0 x 10-6 power cells per mL, plus fibrin.
BIOLOGICALPlacebo (Vehicle)
Placebo (Vehicle) consisting of: Component 1 - acellular fibrinogen solution; Component 2 - acellular thrombin solution
Sponsors
Healthpoint
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Provide informed consent. * Willing to comply with protocol instructions, including allowing all study assessments. * Have a venous leg ulcer (venous etiology)between the knee and ankle, at or above the malleolus. * Venous insufficiency confirmed by duplex Doppler ultrasound examination for valvular or venous incompetence. * Target ulcer duration greater than or equal to 6 weeks but less than or equal to 24 months.
Exclusion criteria
* Women who are pregnant or lactating * Therapy with another investigational agent within thirty (30) days of Screening, or during the study. * A target ulcer of non-venous etiologies. * Refusal of or inability to tolerate compression therapy. * Therapy of the target ulcer with tissue-engineered cell-based skin equivalents within 30 days preceding the Screening Visit. * Therapy of the target ulcer with topical growth factors within 1 week preceding the Screening Visit.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The Average Percent (%) Change From Baseline in the Target Wound Area in Each Treatment Group Over the Twelve-week Double-blind Treatment Period. | Weekly, over the 12 week treatment period, or until wound closure, which ever occurred first | For each treatment group the area of each subject's target ulcer was measured on a weekly basis, for up to 12 weeks, or until wound closure, whichever occurred first, using a laser-based wound imaging system in conjunction with software to measure area. An average of the 12 measurements were assessed. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percent of Change From Baseline in Target Wound Area at Each of the Twelve Double-blind Treatment Weeks. | Weekly, over the 12 week treatment period, or until wound closure, which ever occurred first | For each treatment group the area of each subject's target ulcer was measured on a weekly basis, for up to 12 weeks, using a laser-based wound imaging system in conjunction with software to measure area. |
| Proportion of Subjects Achieving ≥ 50% Decrease in Target Wound Area From Baseline Through Week 13 | Over the 12 week treatment period or until the wound closed, which ever occurred first. | The area of each subject's target wound was measured at each visit and the proportion of subjects with a decrease in area from baseline ≥ 50% was calculated for each treatment group. |
| Kaplan-Meier Probability of Non-Closure | 14 weeks - the final visit for one subject was delayed by two weeks | This key secondary outcome was the days to wound closure based on a Kaplan-Meier survival analysis. |
| Target Ulcer Pain Was Measured Using a Visual Analog Scale [Range: 0mm - 100mm]. Subjects Marked Their Pain Level on a 100 mm Horizontal Line, With a Short Vertical Line Across the Scale, 0 Denoting no Pain and 100mm the Maximum Pain. | Weekly, over the 12 week treatment period | Target ulcer pain was measured using a Visual Analog Scale \[Range: 0mm - 100mm\]. Subjects marked their pain level on a 100 mm horizontal line, with a short vertical line across the scale, 0 denoting no pain and 100mm the maximum pain. Each weekly measurement is reported as the average of all subjects scores at each week per treatment group. |
| Median Time to Achieve Complete Wound Closure, Based on Based on a Kaplan-Meier Survival Analysis, Over the 12-Week Treatment Period From Baseline. | 14 weeks - the final visit for one subject was delayed by two weeks | This key secondary outcome was the days to wound closure based on a Kaplan-Meier survival analysis. |
| Percentage of Participants With Complete Wound Closure at Each Visit | Weekly, over the 12 week treatment period | Treatment groups were compared for the proportion of wounds closed at each weekly visit. For subjects who dropped from the study, their remaining visit values were imputed using LOCF. |
Countries
Canada, United States
Participant flow
Recruitment details
Subjects were screened at 34 sites in the US and one in Canada, between June 11, 2009 and May 5, 2011; sites included independent and hospital wound clinics and private practice sites.
Pre-assignment details
Subjects entered a 2-week run-in; subjects whose wound radius decreased by \< 0.349 cm/2weeks and met all other inclusion/exclusion (I/E) criteria were eligible for randomization.
Participants by arm
| Arm | Count |
|---|---|
| E - HP802-247 Vehicle Placebo (Vehicle), applied at each visit
Placebo (Vehicle): Placebo (Vehicle) consisting of:
Component 1 - acellular fibrinogen solution; Component 2 - acellular thrombin solution | 50 |
| B - Low Q14D Low dose HP802-247 applied at Visits 1, 3, 5, 7, 9, 11 and Placebo at Visits 2, 4, 6, 8, 10, and 12
HP802-247: One dose of HP802-247 consists of 260 microliters (uL) containing keratinocytes and fibroblasts totaling 0.5 x 10-6 power or 5.0 x 10-6 power cells per mL, plus fibrin. | 46 |
| A - Low Q7D Low dose HP802-247, applied at each visit
HP802-247: One dose of HP802-247 consists of 260 microliters (uL) containing keratinocytes and fibroblasts totaling 0.5 x 10-6 power or 5.0 x 10-6 power cells per mL, plus fibrin. | 43 |
| D - High Q14D High dose HP802-247, applied at Visits 1, 3, 5, 7, 9, 11 and Placebo at Visits 2, 4, 6, 8, 10, and 12
HP802-247: One dose of HP802-247 consists of 260 microliters (uL) containing keratinocytes and fibroblasts totaling 0.5 x 10-6 power or 5.0 x 10-6 power cells per mL, plus fibrin. | 44 |
| C - High Q7D High dose HP802-247, applied at each visit
HP802-247: One dose of HP802-247 consists of 260 microliters (uL) containing keratinocytes and fibroblasts totaling 0.5 x 10-6 power or 5.0 x 10-6 power cells per mL, plus fibrin. | 45 |
| Total | 228 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 |
|---|---|---|---|---|---|---|
| Overall Study | Adverse Event | 1 | 0 | 4 | 0 | 0 |
| Overall Study | Lost to Follow-up | 0 | 1 | 1 | 0 | 0 |
| Overall Study | Moved Out of Area | 1 | 0 | 0 | 0 | 0 |
| Overall Study | Non-Compliance | 0 | 0 | 0 | 2 | 0 |
| Overall Study | Physician Decision | 1 | 0 | 0 | 0 | 0 |
| Overall Study | Progressive Disease | 1 | 0 | 0 | 2 | 1 |
| Overall Study | Protocol Violation | 0 | 0 | 0 | 0 | 1 |
| Overall Study | Withdrawal by Subject | 4 | 0 | 0 | 1 | 2 |
Baseline characteristics
| Characteristic | E - HP802-247 Vehicle | B - Low Q14D | A - Low Q7D | D - High Q14D | C - High Q7D | Total |
|---|---|---|---|---|---|---|
| Age, Continuous | 62.1 years STANDARD_DEVIATION 14.1 | 61.7 years STANDARD_DEVIATION 15.7 | 62.6 years STANDARD_DEVIATION 15.4 | 59.8 years STANDARD_DEVIATION 15 | 61.8 years STANDARD_DEVIATION 16.1 | 61.6 years STANDARD_DEVIATION 15.2 |
| Age, Customized Female Age | 69.1 years | 61.8 years | 67.7 years | 65.1 years | 69.7 years | 66.5 years |
| Age, Customized Male Age | 58.4 years | 61.6 years | 60.1 years | 56.0 years | 58.2 years | 59.0 years |
| Ethnicity (NIH/OMB) Hispanic or Latino | 11 Participants | 14 Participants | 10 Participants | 7 Participants | 13 Participants | 55 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 39 Participants | 32 Participants | 33 Participants | 37 Participants | 32 Participants | 173 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 9 Participants | 10 Participants | 9 Participants | 12 Participants | 8 Participants | 48 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 3 Participants | 2 Participants | 4 Participants | 2 Participants | 3 Participants | 14 Participants |
| Race (NIH/OMB) White | 37 Participants | 34 Participants | 30 Participants | 30 Participants | 33 Participants | 164 Participants |
| Sex: Female, Male Female | 17 Participants | 20 Participants | 14 Participants | 22 Participants | 20 Participants | 93 Participants |
| Sex: Female, Male Male | 33 Participants | 26 Participants | 29 Participants | 22 Participants | 25 Participants | 135 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk |
|---|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 26 / 50 | 15 / 46 | 19 / 43 | 16 / 44 | 17 / 45 |
| serious Total, serious adverse events | 4 / 50 | 4 / 46 | 3 / 43 | 3 / 43 | 2 / 45 |
Outcome results
Primary
The Average Percent (%) Change From Baseline in the Target Wound Area in Each Treatment Group Over the Twelve-week Double-blind Treatment Period.
For each treatment group the area of each subject's target ulcer was measured on a weekly basis, for up to 12 weeks, or until wound closure, whichever occurred first, using a laser-based wound imaging system in conjunction with software to measure area. An average of the 12 measurements were assessed.
Time frame: Weekly, over the 12 week treatment period, or until wound closure, which ever occurred first
Population: ITT population.: Subjects who received at least one dose of test article. The primary analysis was performed using a two-way ANCOVA model, which included treatment group (the effect of interest), site, and the baseline target wound area (the covariate), with significance being at P \< 0.05.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| B - Low Q14D | The Average Percent (%) Change From Baseline in the Target Wound Area in Each Treatment Group Over the Twelve-week Double-blind Treatment Period. | -77.11 percent change | Standard Deviation 21.95 |
| A - Low Q7D | The Average Percent (%) Change From Baseline in the Target Wound Area in Each Treatment Group Over the Twelve-week Double-blind Treatment Period. | -70.15 percent change | Standard Deviation 21.66 |
| D - High Q14D | The Average Percent (%) Change From Baseline in the Target Wound Area in Each Treatment Group Over the Twelve-week Double-blind Treatment Period. | -68.14 percent change | Standard Deviation 26.29 |
| C - High Q7D | The Average Percent (%) Change From Baseline in the Target Wound Area in Each Treatment Group Over the Twelve-week Double-blind Treatment Period. | -72.89 percent change | Standard Deviation 27.27 |
| E - HP802-247 Vehicle | The Average Percent (%) Change From Baseline in the Target Wound Area in Each Treatment Group Over the Twelve-week Double-blind Treatment Period. | -60.38 percent change | Standard Deviation 29.79 |
p-value: 0.00028t-test, 2 sided
p-value: 0.0899t-test, 2 sided
p-value: 0.1586t-test, 2 sided
p-value: 0.0295t-test, 2 sided
Secondary
Kaplan-Meier Probability of Non-Closure
This key secondary outcome was the days to wound closure based on a Kaplan-Meier survival analysis.
Time frame: 14 weeks - the final visit for one subject was delayed by two weeks
Population: ITT Populations: Subjects who received at least one dose of test article. Data were analyzed using the Kaplan-Meier survival procedure, with significance being at P \< 0.05.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| B - Low Q14D | Kaplan-Meier Probability of Non-Closure | 01 week | 1 Probability of Non-Closure |
| B - Low Q14D | Kaplan-Meier Probability of Non-Closure | 09 weeks | 0.534 Probability of Non-Closure |
| B - Low Q14D | Kaplan-Meier Probability of Non-Closure | 07 weeks | 0.706 Probability of Non-Closure |
| B - Low Q14D | Kaplan-Meier Probability of Non-Closure | 08 weeks | 0.663 Probability of Non-Closure |
| B - Low Q14D | Kaplan-Meier Probability of Non-Closure | 13 weeks | 0.42 Probability of Non-Closure |
| B - Low Q14D | Kaplan-Meier Probability of Non-Closure | 03 weeks | 0.98 Probability of Non-Closure |
| B - Low Q14D | Kaplan-Meier Probability of Non-Closure | 12 weeks | 0.512 Probability of Non-Closure |
| B - Low Q14D | Kaplan-Meier Probability of Non-Closure | 04 weeks | 0.918 Probability of Non-Closure |
| B - Low Q14D | Kaplan-Meier Probability of Non-Closure | 14 weeks | 0.42 Probability of Non-Closure |
| B - Low Q14D | Kaplan-Meier Probability of Non-Closure | 11 weeks | 0.512 Probability of Non-Closure |
| B - Low Q14D | Kaplan-Meier Probability of Non-Closure | 05 weeks | 0.898 Probability of Non-Closure |
| B - Low Q14D | Kaplan-Meier Probability of Non-Closure | 02 weeks | 1 Probability of Non-Closure |
| B - Low Q14D | Kaplan-Meier Probability of Non-Closure | 10 weeks | 0.512 Probability of Non-Closure |
| B - Low Q14D | Kaplan-Meier Probability of Non-Closure | 06 weeks | 0.834 Probability of Non-Closure |
| A - Low Q7D | Kaplan-Meier Probability of Non-Closure | 06 weeks | 0.596 Probability of Non-Closure |
| A - Low Q7D | Kaplan-Meier Probability of Non-Closure | 05 weeks | 0.71 Probability of Non-Closure |
| A - Low Q7D | Kaplan-Meier Probability of Non-Closure | 04 weeks | 0.934 Probability of Non-Closure |
| A - Low Q7D | Kaplan-Meier Probability of Non-Closure | 07 weeks | 0.596 Probability of Non-Closure |
| A - Low Q7D | Kaplan-Meier Probability of Non-Closure | 02 weeks | 0.978 Probability of Non-Closure |
| A - Low Q7D | Kaplan-Meier Probability of Non-Closure | 08 weeks | 0.431 Probability of Non-Closure |
| A - Low Q7D | Kaplan-Meier Probability of Non-Closure | 09 weeks | 0.359 Probability of Non-Closure |
| A - Low Q7D | Kaplan-Meier Probability of Non-Closure | 01 week | 1 Probability of Non-Closure |
| A - Low Q7D | Kaplan-Meier Probability of Non-Closure | 13 weeks | 0.237 Probability of Non-Closure |
| A - Low Q7D | Kaplan-Meier Probability of Non-Closure | 11 weeks | 0.332 Probability of Non-Closure |
| A - Low Q7D | Kaplan-Meier Probability of Non-Closure | 10 weeks | 0.332 Probability of Non-Closure |
| A - Low Q7D | Kaplan-Meier Probability of Non-Closure | 03 weeks | 0.934 Probability of Non-Closure |
| A - Low Q7D | Kaplan-Meier Probability of Non-Closure | 14 weeks | 0 Probability of Non-Closure |
| A - Low Q7D | Kaplan-Meier Probability of Non-Closure | 12 weeks | 0.276 Probability of Non-Closure |
| D - High Q14D | Kaplan-Meier Probability of Non-Closure | 06 weeks | 0.814 Probability of Non-Closure |
| D - High Q14D | Kaplan-Meier Probability of Non-Closure | 01 week | 0.977 Probability of Non-Closure |
| D - High Q14D | Kaplan-Meier Probability of Non-Closure | 02 weeks | 0.977 Probability of Non-Closure |
| D - High Q14D | Kaplan-Meier Probability of Non-Closure | 03 weeks | 0.977 Probability of Non-Closure |
| D - High Q14D | Kaplan-Meier Probability of Non-Closure | 04 weeks | 0.907 Probability of Non-Closure |
| D - High Q14D | Kaplan-Meier Probability of Non-Closure | 05 weeks | 0.814 Probability of Non-Closure |
| D - High Q14D | Kaplan-Meier Probability of Non-Closure | 07 weeks | 0.628 Probability of Non-Closure |
| D - High Q14D | Kaplan-Meier Probability of Non-Closure | 08 weeks | 0.581 Probability of Non-Closure |
| D - High Q14D | Kaplan-Meier Probability of Non-Closure | 09 weeks | 0.558 Probability of Non-Closure |
| D - High Q14D | Kaplan-Meier Probability of Non-Closure | 10 weeks | 0.558 Probability of Non-Closure |
| D - High Q14D | Kaplan-Meier Probability of Non-Closure | 11 weeks | 0.393 Probability of Non-Closure |
| D - High Q14D | Kaplan-Meier Probability of Non-Closure | 12 weeks | 0.393 Probability of Non-Closure |
| D - High Q14D | Kaplan-Meier Probability of Non-Closure | 13 weeks | 0.393 Probability of Non-Closure |
| D - High Q14D | Kaplan-Meier Probability of Non-Closure | 14 weeks | 0.393 Probability of Non-Closure |
| C - High Q7D | Kaplan-Meier Probability of Non-Closure | 06 weeks | 0.791 Probability of Non-Closure |
| C - High Q7D | Kaplan-Meier Probability of Non-Closure | 09 weeks | 0.537 Probability of Non-Closure |
| C - High Q7D | Kaplan-Meier Probability of Non-Closure | 05 weeks | 0.791 Probability of Non-Closure |
| C - High Q7D | Kaplan-Meier Probability of Non-Closure | 10 weeks | 0.537 Probability of Non-Closure |
| C - High Q7D | Kaplan-Meier Probability of Non-Closure | 04 weeks | 0.907 Probability of Non-Closure |
| C - High Q7D | Kaplan-Meier Probability of Non-Closure | 01 week | 1 Probability of Non-Closure |
| C - High Q7D | Kaplan-Meier Probability of Non-Closure | 11 weeks | 0.46 Probability of Non-Closure |
| C - High Q7D | Kaplan-Meier Probability of Non-Closure | 03 weeks | 0.953 Probability of Non-Closure |
| C - High Q7D | Kaplan-Meier Probability of Non-Closure | 12 weeks | 0.379 Probability of Non-Closure |
| C - High Q7D | Kaplan-Meier Probability of Non-Closure | 02 weeks | 1 Probability of Non-Closure |
| C - High Q7D | Kaplan-Meier Probability of Non-Closure | 14 weeks | 0.32 Probability of Non-Closure |
| C - High Q7D | Kaplan-Meier Probability of Non-Closure | 07 weeks | 0.741 Probability of Non-Closure |
| C - High Q7D | Kaplan-Meier Probability of Non-Closure | 13 weeks | 0.32 Probability of Non-Closure |
| C - High Q7D | Kaplan-Meier Probability of Non-Closure | 08 weeks | 0.537 Probability of Non-Closure |
| E - HP802-247 Vehicle | Kaplan-Meier Probability of Non-Closure | 07 weeks | 0.591 Probability of Non-Closure |
| E - HP802-247 Vehicle | Kaplan-Meier Probability of Non-Closure | 14 weeks | 0.288 Probability of Non-Closure |
| E - HP802-247 Vehicle | Kaplan-Meier Probability of Non-Closure | 09 weeks | 0.445 Probability of Non-Closure |
| E - HP802-247 Vehicle | Kaplan-Meier Probability of Non-Closure | 05 weeks | 0.707 Probability of Non-Closure |
| E - HP802-247 Vehicle | Kaplan-Meier Probability of Non-Closure | 08 weeks | 0.543 Probability of Non-Closure |
| E - HP802-247 Vehicle | Kaplan-Meier Probability of Non-Closure | 01 week | 1 Probability of Non-Closure |
| E - HP802-247 Vehicle | Kaplan-Meier Probability of Non-Closure | 12 weeks | 0.288 Probability of Non-Closure |
| E - HP802-247 Vehicle | Kaplan-Meier Probability of Non-Closure | 10 weeks | 0.418 Probability of Non-Closure |
| E - HP802-247 Vehicle | Kaplan-Meier Probability of Non-Closure | 04 weeks | 0.867 Probability of Non-Closure |
| E - HP802-247 Vehicle | Kaplan-Meier Probability of Non-Closure | 02 weeks | 0.978 Probability of Non-Closure |
| E - HP802-247 Vehicle | Kaplan-Meier Probability of Non-Closure | 06 weeks | 0.661 Probability of Non-Closure |
| E - HP802-247 Vehicle | Kaplan-Meier Probability of Non-Closure | 13 weeks | 0.288 Probability of Non-Closure |
| E - HP802-247 Vehicle | Kaplan-Meier Probability of Non-Closure | 11 weeks | 0.418 Probability of Non-Closure |
| E - HP802-247 Vehicle | Kaplan-Meier Probability of Non-Closure | 03 weeks | 0.889 Probability of Non-Closure |
Secondary
Median Time to Achieve Complete Wound Closure, Based on Based on a Kaplan-Meier Survival Analysis, Over the 12-Week Treatment Period From Baseline.
This key secondary outcome was the days to wound closure based on a Kaplan-Meier survival analysis.
Time frame: 14 weeks - the final visit for one subject was delayed by two weeks
Population: ITT Populations: Subjects who received at least one dose of test article. Data were analyzed using the Kaplan-Meier survival procedure, with significance being at P \< 0.05.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| B - Low Q14D | Median Time to Achieve Complete Wound Closure, Based on Based on a Kaplan-Meier Survival Analysis, Over the 12-Week Treatment Period From Baseline. | 71 Days to Closure |
| A - Low Q7D | Median Time to Achieve Complete Wound Closure, Based on Based on a Kaplan-Meier Survival Analysis, Over the 12-Week Treatment Period From Baseline. | 50 Days to Closure |
| D - High Q14D | Median Time to Achieve Complete Wound Closure, Based on Based on a Kaplan-Meier Survival Analysis, Over the 12-Week Treatment Period From Baseline. | 64 Days to Closure |
| C - High Q7D | Median Time to Achieve Complete Wound Closure, Based on Based on a Kaplan-Meier Survival Analysis, Over the 12-Week Treatment Period From Baseline. | 57 Days to Closure |
| E - HP802-247 Vehicle | Median Time to Achieve Complete Wound Closure, Based on Based on a Kaplan-Meier Survival Analysis, Over the 12-Week Treatment Period From Baseline. | 57 Days to Closure |
p-value: 0.0211ANCOVA
p-value: 0.021295% CI: [1.09, 3.04]Regression, Cox
p-value: 0.59ANCOVA
p-value: 0.5395% CI: [0.69, 2.05]Regression, Cox
p-value: 0.26ANCOVA
p-value: 0.1995% CI: [0.84, 2.44]Regression, Cox
p-value: 0.1ANCOVA
p-value: 0.0695% CI: [0.97, 2.77]Regression, Cox
Secondary
Percentage of Participants With Complete Wound Closure at Each Visit
Treatment groups were compared for the proportion of wounds closed at each weekly visit. For subjects who dropped from the study, their remaining visit values were imputed using LOCF.
Time frame: Weekly, over the 12 week treatment period
Population: ITT Populations: Subjects who received at least one dose of test article. Analysis was by the Cochrane Mantel Haenszel (CMH) test
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| B - Low Q14D | Percentage of Participants With Complete Wound Closure at Each Visit | Week 07 | 28.0 percentage of participants |
| B - Low Q14D | Percentage of Participants With Complete Wound Closure at Each Visit | Week 11 | 40.0 percentage of participants |
| B - Low Q14D | Percentage of Participants With Complete Wound Closure at Each Visit | Week 10 | 40.0 percentage of participants |
| B - Low Q14D | Percentage of Participants With Complete Wound Closure at Each Visit | Week 04 | 10.0 percentage of participants |
| B - Low Q14D | Percentage of Participants With Complete Wound Closure at Each Visit | Week 01 | 0 percentage of participants |
| B - Low Q14D | Percentage of Participants With Complete Wound Closure at Each Visit | Week 12 | 46.0 percentage of participants |
| B - Low Q14D | Percentage of Participants With Complete Wound Closure at Each Visit | Week 08 | 36.0 percentage of participants |
| B - Low Q14D | Percentage of Participants With Complete Wound Closure at Each Visit | Week 09 | 36.0 percentage of participants |
| B - Low Q14D | Percentage of Participants With Complete Wound Closure at Each Visit | Week 05 | 16.0 percentage of participants |
| B - Low Q14D | Percentage of Participants With Complete Wound Closure at Each Visit | Week 03 | 8.0 percentage of participants |
| B - Low Q14D | Percentage of Participants With Complete Wound Closure at Each Visit | Week 02 | 2.0 percentage of participants |
| B - Low Q14D | Percentage of Participants With Complete Wound Closure at Each Visit | Week 06 | 24.0 percentage of participants |
| A - Low Q7D | Percentage of Participants With Complete Wound Closure at Each Visit | Week 01 | 4.3 percentage of participants |
| A - Low Q7D | Percentage of Participants With Complete Wound Closure at Each Visit | Week 06 | 47.8 percentage of participants |
| A - Low Q7D | Percentage of Participants With Complete Wound Closure at Each Visit | Week 02 | 8.7 percentage of participants |
| A - Low Q7D | Percentage of Participants With Complete Wound Closure at Each Visit | Week 07 | 52.2 percentage of participants |
| A - Low Q7D | Percentage of Participants With Complete Wound Closure at Each Visit | Week 11 | 65.2 percentage of participants |
| A - Low Q7D | Percentage of Participants With Complete Wound Closure at Each Visit | Week 03 | 23.9 percentage of participants |
| A - Low Q7D | Percentage of Participants With Complete Wound Closure at Each Visit | Week 10 | 60.9 percentage of participants |
| A - Low Q7D | Percentage of Participants With Complete Wound Closure at Each Visit | Week 04 | 30.4 percentage of participants |
| A - Low Q7D | Percentage of Participants With Complete Wound Closure at Each Visit | Week 12 | 69.6 percentage of participants |
| A - Low Q7D | Percentage of Participants With Complete Wound Closure at Each Visit | Week 09 | 60.9 percentage of participants |
| A - Low Q7D | Percentage of Participants With Complete Wound Closure at Each Visit | Week 05 | 37.0 percentage of participants |
| A - Low Q7D | Percentage of Participants With Complete Wound Closure at Each Visit | Week 08 | 58.7 percentage of participants |
| D - High Q14D | Percentage of Participants With Complete Wound Closure at Each Visit | Week 08 | 41.9 percentage of participants |
| D - High Q14D | Percentage of Participants With Complete Wound Closure at Each Visit | Week 01 | 2.3 percentage of participants |
| D - High Q14D | Percentage of Participants With Complete Wound Closure at Each Visit | Week 02 | 2.3 percentage of participants |
| D - High Q14D | Percentage of Participants With Complete Wound Closure at Each Visit | Week 03 | 9.3 percentage of participants |
| D - High Q14D | Percentage of Participants With Complete Wound Closure at Each Visit | Week 04 | 18.6 percentage of participants |
| D - High Q14D | Percentage of Participants With Complete Wound Closure at Each Visit | Week 05 | 25.6 percentage of participants |
| D - High Q14D | Percentage of Participants With Complete Wound Closure at Each Visit | Week 06 | 39.5 percentage of participants |
| D - High Q14D | Percentage of Participants With Complete Wound Closure at Each Visit | Week 07 | 41.9 percentage of participants |
| D - High Q14D | Percentage of Participants With Complete Wound Closure at Each Visit | Week 09 | 55.8 percentage of participants |
| D - High Q14D | Percentage of Participants With Complete Wound Closure at Each Visit | Week 10 | 60.5 percentage of participants |
| D - High Q14D | Percentage of Participants With Complete Wound Closure at Each Visit | Week 11 | 58.1 percentage of participants |
| D - High Q14D | Percentage of Participants With Complete Wound Closure at Each Visit | Week 12 | 58.1 percentage of participants |
| C - High Q7D | Percentage of Participants With Complete Wound Closure at Each Visit | Week 04 | 20.9 percentage of participants |
| C - High Q7D | Percentage of Participants With Complete Wound Closure at Each Visit | Week 03 | 14.0 percentage of participants |
| C - High Q7D | Percentage of Participants With Complete Wound Closure at Each Visit | Week 01 | 0 percentage of participants |
| C - High Q7D | Percentage of Participants With Complete Wound Closure at Each Visit | Week 09 | 48.8 percentage of participants |
| C - High Q7D | Percentage of Participants With Complete Wound Closure at Each Visit | Week 11 | 60.5 percentage of participants |
| C - High Q7D | Percentage of Participants With Complete Wound Closure at Each Visit | Week 05 | 23.3 percentage of participants |
| C - High Q7D | Percentage of Participants With Complete Wound Closure at Each Visit | Week 02 | 7.0 percentage of participants |
| C - High Q7D | Percentage of Participants With Complete Wound Closure at Each Visit | Week 08 | 48.8 percentage of participants |
| C - High Q7D | Percentage of Participants With Complete Wound Closure at Each Visit | Week 12 | 65.1 percentage of participants |
| C - High Q7D | Percentage of Participants With Complete Wound Closure at Each Visit | Week 07 | 39.5 percentage of participants |
| C - High Q7D | Percentage of Participants With Complete Wound Closure at Each Visit | Week 10 | 53.5 percentage of participants |
| C - High Q7D | Percentage of Participants With Complete Wound Closure at Each Visit | Week 06 | 27.9 percentage of participants |
| E - HP802-247 Vehicle | Percentage of Participants With Complete Wound Closure at Each Visit | Week 10 | 62.2 percentage of participants |
| E - HP802-247 Vehicle | Percentage of Participants With Complete Wound Closure at Each Visit | Week 08 | 51.1 percentage of participants |
| E - HP802-247 Vehicle | Percentage of Participants With Complete Wound Closure at Each Visit | Week 04 | 28.9 percentage of participants |
| E - HP802-247 Vehicle | Percentage of Participants With Complete Wound Closure at Each Visit | Week 09 | 55.6 percentage of participants |
| E - HP802-247 Vehicle | Percentage of Participants With Complete Wound Closure at Each Visit | Week 03 | 20.0 percentage of participants |
| E - HP802-247 Vehicle | Percentage of Participants With Complete Wound Closure at Each Visit | Week 05 | 33.3 percentage of participants |
| E - HP802-247 Vehicle | Percentage of Participants With Complete Wound Closure at Each Visit | Week 02 | 11.1 percentage of participants |
| E - HP802-247 Vehicle | Percentage of Participants With Complete Wound Closure at Each Visit | Week 12 | 64.4 percentage of participants |
| E - HP802-247 Vehicle | Percentage of Participants With Complete Wound Closure at Each Visit | Week 11 | 64.4 percentage of participants |
| E - HP802-247 Vehicle | Percentage of Participants With Complete Wound Closure at Each Visit | Week 06 | 40.0 percentage of participants |
| E - HP802-247 Vehicle | Percentage of Participants With Complete Wound Closure at Each Visit | Week 01 | 2.2 percentage of participants |
| E - HP802-247 Vehicle | Percentage of Participants With Complete Wound Closure at Each Visit | Week 07 | 44.4 percentage of participants |
p-value: 0.017Cochran-Mantel-Haenszel
p-value: 0.041Cochran-Mantel-Haenszel
p-value: 0.017Cochran-Mantel-Haenszel
p-value: 0.011Cochran-Mantel-Haenszel
p-value: 0.014Cochran-Mantel-Haenszel
p-value: 0.029Cochran-Mantel-Haenszel
p-value: 0.021Cochran-Mantel-Haenszel
p-value: 0.041Cochran-Mantel-Haenszel
p-value: 0.044Cochran-Mantel-Haenszel
p-value: 0.013Cochran-Mantel-Haenszel
p-value: 0.024Cochran-Mantel-Haenszel
p-value: 0.027Cochran-Mantel-Haenszel
Secondary
Percent of Change From Baseline in Target Wound Area at Each of the Twelve Double-blind Treatment Weeks.
For each treatment group the area of each subject's target ulcer was measured on a weekly basis, for up to 12 weeks, using a laser-based wound imaging system in conjunction with software to measure area.
Time frame: Weekly, over the 12 week treatment period, or until wound closure, which ever occurred first
Population: ITT population. Subjects who received at least one dose of test article. The data at each week were analyzed using a two-way ANCOVA model, which included treatment group (the effect of interest), site, and the baseline target wound area (the covariate). Significance was attained at P \< 0.05.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| B - Low Q14D | Percent of Change From Baseline in Target Wound Area at Each of the Twelve Double-blind Treatment Weeks. | Tx Week 8 | -66.62 Percent change | Standard Error 5.04 |
| B - Low Q14D | Percent of Change From Baseline in Target Wound Area at Each of the Twelve Double-blind Treatment Weeks. | Tx Week 11 | -77.05 Percent change | Standard Error 3.57 |
| B - Low Q14D | Percent of Change From Baseline in Target Wound Area at Each of the Twelve Double-blind Treatment Weeks. | Tx Week 1 | -22.94 Percent change | Standard Error 3.97 |
| B - Low Q14D | Percent of Change From Baseline in Target Wound Area at Each of the Twelve Double-blind Treatment Weeks. | Tx Week 4 | -59.55 Percent change | Standard Error 5.28 |
| B - Low Q14D | Percent of Change From Baseline in Target Wound Area at Each of the Twelve Double-blind Treatment Weeks. | Tx Week 6 | -63.93 Percent change | Standard Error 4.63 |
| B - Low Q14D | Percent of Change From Baseline in Target Wound Area at Each of the Twelve Double-blind Treatment Weeks. | Tx Week 12 | -80.69 Percent change | Standard Error 3.54 |
| B - Low Q14D | Percent of Change From Baseline in Target Wound Area at Each of the Twelve Double-blind Treatment Weeks. | Tx Week 10 | -76.19 Percent change | Standard Error 3.39 |
| B - Low Q14D | Percent of Change From Baseline in Target Wound Area at Each of the Twelve Double-blind Treatment Weeks. | Tx Week 3 | -47.30 Percent change | Standard Error 5 |
| B - Low Q14D | Percent of Change From Baseline in Target Wound Area at Each of the Twelve Double-blind Treatment Weeks. | Tx Week 5 | -60.54 Percent change | Standard Error 5.29 |
| B - Low Q14D | Percent of Change From Baseline in Target Wound Area at Each of the Twelve Double-blind Treatment Weeks. | Tx Week 7 | -65.38 Percent change | Standard Error 4.64 |
| B - Low Q14D | Percent of Change From Baseline in Target Wound Area at Each of the Twelve Double-blind Treatment Weeks. | Tx Week 2 | -39.94 Percent change | Standard Error 4.9 |
| B - Low Q14D | Percent of Change From Baseline in Target Wound Area at Each of the Twelve Double-blind Treatment Weeks. | Tx Week 9 | -69.03 Percent change | Standard Error 4.78 |
| A - Low Q7D | Percent of Change From Baseline in Target Wound Area at Each of the Twelve Double-blind Treatment Weeks. | Tx Week 12 | -90.67 Percent change | Standard Error 3.69 |
| A - Low Q7D | Percent of Change From Baseline in Target Wound Area at Each of the Twelve Double-blind Treatment Weeks. | Tx Week 6 | -81.05 Percent change | Standard Error 4.83 |
| A - Low Q7D | Percent of Change From Baseline in Target Wound Area at Each of the Twelve Double-blind Treatment Weeks. | Tx Week 2 | -58.95 Percent change | Standard Error 5.11 |
| A - Low Q7D | Percent of Change From Baseline in Target Wound Area at Each of the Twelve Double-blind Treatment Weeks. | Tx Week 7 | -87.22 Percent change | Standard Error 4.84 |
| A - Low Q7D | Percent of Change From Baseline in Target Wound Area at Each of the Twelve Double-blind Treatment Weeks. | Tx Week 1 | -38.88 Percent change | Standard Error 4.14 |
| A - Low Q7D | Percent of Change From Baseline in Target Wound Area at Each of the Twelve Double-blind Treatment Weeks. | Tx Week 11 | -89.26 Percent change | Standard Error 3.72 |
| A - Low Q7D | Percent of Change From Baseline in Target Wound Area at Each of the Twelve Double-blind Treatment Weeks. | Tx Week 3 | -65.56 Percent change | Standard Error 5.22 |
| A - Low Q7D | Percent of Change From Baseline in Target Wound Area at Each of the Twelve Double-blind Treatment Weeks. | Tx Week 8 | -83.00 Percent change | Standard Error 5.26 |
| A - Low Q7D | Percent of Change From Baseline in Target Wound Area at Each of the Twelve Double-blind Treatment Weeks. | Tx Week 10 | -89.65 Percent change | Standard Error 3.54 |
| A - Low Q7D | Percent of Change From Baseline in Target Wound Area at Each of the Twelve Double-blind Treatment Weeks. | Tx Week 4 | -73.46 Percent change | Standard Error 5.51 |
| A - Low Q7D | Percent of Change From Baseline in Target Wound Area at Each of the Twelve Double-blind Treatment Weeks. | Tx Week 9 | -83.28 Percent change | Standard Error 4.99 |
| A - Low Q7D | Percent of Change From Baseline in Target Wound Area at Each of the Twelve Double-blind Treatment Weeks. | Tx Week 5 | -79.98 Percent change | Standard Error 5.52 |
| D - High Q14D | Percent of Change From Baseline in Target Wound Area at Each of the Twelve Double-blind Treatment Weeks. | Tx Week 11 | -87.49 Percent change | Standard Error 3.84 |
| D - High Q14D | Percent of Change From Baseline in Target Wound Area at Each of the Twelve Double-blind Treatment Weeks. | Tx Week 1 | -27.89 Percent change | Standard Error 4.27 |
| D - High Q14D | Percent of Change From Baseline in Target Wound Area at Each of the Twelve Double-blind Treatment Weeks. | Tx Week 2 | -46.06 Percent change | Standard Error 5.26 |
| D - High Q14D | Percent of Change From Baseline in Target Wound Area at Each of the Twelve Double-blind Treatment Weeks. | Tx Week 3 | -53.5 Percent change | Standard Error 5.37 |
| D - High Q14D | Percent of Change From Baseline in Target Wound Area at Each of the Twelve Double-blind Treatment Weeks. | Tx Week 4 | -62.14 Percent change | Standard Error 5.68 |
| D - High Q14D | Percent of Change From Baseline in Target Wound Area at Each of the Twelve Double-blind Treatment Weeks. | Tx Week 5 | -68.95 Percent change | Standard Error 5.68 |
| D - High Q14D | Percent of Change From Baseline in Target Wound Area at Each of the Twelve Double-blind Treatment Weeks. | Tx Week 6 | -76.01 Percent change | Standard Error 4.98 |
| D - High Q14D | Percent of Change From Baseline in Target Wound Area at Each of the Twelve Double-blind Treatment Weeks. | Tx Week 7 | -79.84 Percent change | Standard Error 4.99 |
| D - High Q14D | Percent of Change From Baseline in Target Wound Area at Each of the Twelve Double-blind Treatment Weeks. | Tx Week 8 | -80.6 Percent change | Standard Error 5.42 |
| D - High Q14D | Percent of Change From Baseline in Target Wound Area at Each of the Twelve Double-blind Treatment Weeks. | Tx Week 9 | -83.96 Percent change | Standard Error 5.14 |
| D - High Q14D | Percent of Change From Baseline in Target Wound Area at Each of the Twelve Double-blind Treatment Weeks. | Tx Week 10 | -85.79 Percent change | Standard Error 3.65 |
| D - High Q14D | Percent of Change From Baseline in Target Wound Area at Each of the Twelve Double-blind Treatment Weeks. | Tx Week 12 | -86.87 Percent change | Standard Error 3.8 |
| C - High Q7D | Percent of Change From Baseline in Target Wound Area at Each of the Twelve Double-blind Treatment Weeks. | Tx Week 6 | -74.7 Percent change | Standard Error 4.97 |
| C - High Q7D | Percent of Change From Baseline in Target Wound Area at Each of the Twelve Double-blind Treatment Weeks. | Tx Week 1 | -25.88 Percent change | Standard Error 4.26 |
| C - High Q7D | Percent of Change From Baseline in Target Wound Area at Each of the Twelve Double-blind Treatment Weeks. | Tx Week 8 | -81.58 Percent change | Standard Error 5.42 |
| C - High Q7D | Percent of Change From Baseline in Target Wound Area at Each of the Twelve Double-blind Treatment Weeks. | Tx Week 5 | -61.87 Percent change | Standard Error 5.68 |
| C - High Q7D | Percent of Change From Baseline in Target Wound Area at Each of the Twelve Double-blind Treatment Weeks. | Tx Week 9 | -84.28 Percent change | Standard Error 5.14 |
| C - High Q7D | Percent of Change From Baseline in Target Wound Area at Each of the Twelve Double-blind Treatment Weeks. | Tx Week 4 | -60.68 Percent change | Standard Error 5.68 |
| C - High Q7D | Percent of Change From Baseline in Target Wound Area at Each of the Twelve Double-blind Treatment Weeks. | Tx Week 12 | -84.52 Percent change | Standard Error 3.8 |
| C - High Q7D | Percent of Change From Baseline in Target Wound Area at Each of the Twelve Double-blind Treatment Weeks. | Tx Week 10 | -86.98 Percent change | Standard Error 3.65 |
| C - High Q7D | Percent of Change From Baseline in Target Wound Area at Each of the Twelve Double-blind Treatment Weeks. | Tx Week 3 | -55.2 Percent change | Standard Error 5.37 |
| C - High Q7D | Percent of Change From Baseline in Target Wound Area at Each of the Twelve Double-blind Treatment Weeks. | Tx Week 2 | -43.69 Percent change | Standard Error 5.26 |
| C - High Q7D | Percent of Change From Baseline in Target Wound Area at Each of the Twelve Double-blind Treatment Weeks. | Tx Week 11 | -83.37 Percent change | Standard Error 3.83 |
| C - High Q7D | Percent of Change From Baseline in Target Wound Area at Each of the Twelve Double-blind Treatment Weeks. | Tx Week 7 | -77.63 Percent change | Standard Error 4.98 |
| E - HP802-247 Vehicle | Percent of Change From Baseline in Target Wound Area at Each of the Twelve Double-blind Treatment Weeks. | Tx Week 6 | -81.06 Percent change | Standard Error 4.86 |
| E - HP802-247 Vehicle | Percent of Change From Baseline in Target Wound Area at Each of the Twelve Double-blind Treatment Weeks. | Tx Week 10 | -87.74 Percent change | Standard Error 3.56 |
| E - HP802-247 Vehicle | Percent of Change From Baseline in Target Wound Area at Each of the Twelve Double-blind Treatment Weeks. | Tx Week 1 | -34.97 Percent change | Standard Error 4.17 |
| E - HP802-247 Vehicle | Percent of Change From Baseline in Target Wound Area at Each of the Twelve Double-blind Treatment Weeks. | Tx Week 8 | -81.98 Percent change | Standard Error 5.3 |
| E - HP802-247 Vehicle | Percent of Change From Baseline in Target Wound Area at Each of the Twelve Double-blind Treatment Weeks. | Tx Week 2 | -49.89 Percent change | Standard Error 5.14 |
| E - HP802-247 Vehicle | Percent of Change From Baseline in Target Wound Area at Each of the Twelve Double-blind Treatment Weeks. | Tx Week 4 | -63.92 Percent change | Standard Error 5.55 |
| E - HP802-247 Vehicle | Percent of Change From Baseline in Target Wound Area at Each of the Twelve Double-blind Treatment Weeks. | Tx Week 12 | -86.93 Percent change | Standard Error 3.72 |
| E - HP802-247 Vehicle | Percent of Change From Baseline in Target Wound Area at Each of the Twelve Double-blind Treatment Weeks. | Tx Week 5 | -72.41 Percent change | Standard Error 5.55 |
| E - HP802-247 Vehicle | Percent of Change From Baseline in Target Wound Area at Each of the Twelve Double-blind Treatment Weeks. | Tx Week 9 | -86.17 Percent change | Standard Error 5.02 |
| E - HP802-247 Vehicle | Percent of Change From Baseline in Target Wound Area at Each of the Twelve Double-blind Treatment Weeks. | Tx Week 7 | -79.81 Percent change | Standard Error 4.87 |
| E - HP802-247 Vehicle | Percent of Change From Baseline in Target Wound Area at Each of the Twelve Double-blind Treatment Weeks. | Tx Week 3 | -56.66 Percent change | Standard Error 5.25 |
| E - HP802-247 Vehicle | Percent of Change From Baseline in Target Wound Area at Each of the Twelve Double-blind Treatment Weeks. | Tx Week 11 | -87.54 Percent change | Standard Error 3.75 |
p-value: 0.395ANCOVA
p-value: 0.037ANCOVA
p-value: 0.064ANCOVA
p-value: 0.161ANCOVA
p-value: 0.39ANCOVA
p-value: 0.079ANCOVA
p-value: 0.069ANCOVA
p-value: 0.026ANCOVA
p-value: 0.133ANCOVA
p-value: 0.089ANCOVA
p-value: 0.057ANCOVA
p-value: 0.127ANCOVA
Secondary
Proportion of Subjects Achieving ≥ 50% Decrease in Target Wound Area From Baseline Through Week 13
The area of each subject's target wound was measured at each visit and the proportion of subjects with a decrease in area from baseline ≥ 50% was calculated for each treatment group.
Time frame: Over the 12 week treatment period or until the wound closed, which ever occurred first.
Population: The non-parametric Cochrane Mantel Haenszel test with adjustment for pooled site was used to examine treatment effects at each time point on the proportion of responders who have an average of ≥50% reduction from baseline in wound area over the treatment period. The test was performed separately for each pair of an active treatment vs. placebo.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| B - Low Q14D | Proportion of Subjects Achieving ≥ 50% Decrease in Target Wound Area From Baseline Through Week 13 | Visit 9 | 36 Responders |
| B - Low Q14D | Proportion of Subjects Achieving ≥ 50% Decrease in Target Wound Area From Baseline Through Week 13 | Visit 12 | 40 Responders |
| B - Low Q14D | Proportion of Subjects Achieving ≥ 50% Decrease in Target Wound Area From Baseline Through Week 13 | Visit 2 | 8 Responders |
| B - Low Q14D | Proportion of Subjects Achieving ≥ 50% Decrease in Target Wound Area From Baseline Through Week 13 | Visit 5 | 32 Responders |
| B - Low Q14D | Proportion of Subjects Achieving ≥ 50% Decrease in Target Wound Area From Baseline Through Week 13 | Visit 7 | 36 Responders |
| B - Low Q14D | Proportion of Subjects Achieving ≥ 50% Decrease in Target Wound Area From Baseline Through Week 13 | Visit 13 | 45 Responders |
| B - Low Q14D | Proportion of Subjects Achieving ≥ 50% Decrease in Target Wound Area From Baseline Through Week 13 | Visit 11 | 42 Responders |
| B - Low Q14D | Proportion of Subjects Achieving ≥ 50% Decrease in Target Wound Area From Baseline Through Week 13 | Visit 4 | 28 Responders |
| B - Low Q14D | Proportion of Subjects Achieving ≥ 50% Decrease in Target Wound Area From Baseline Through Week 13 | Visit 6 | 36 Responders |
| B - Low Q14D | Proportion of Subjects Achieving ≥ 50% Decrease in Target Wound Area From Baseline Through Week 13 | Visit 8 | 36 Responders |
| B - Low Q14D | Proportion of Subjects Achieving ≥ 50% Decrease in Target Wound Area From Baseline Through Week 13 | Visit 3 | 22 Responders |
| B - Low Q14D | Proportion of Subjects Achieving ≥ 50% Decrease in Target Wound Area From Baseline Through Week 13 | Visit 10 | 41 Responders |
| A - Low Q7D | Proportion of Subjects Achieving ≥ 50% Decrease in Target Wound Area From Baseline Through Week 13 | Visit 13 | 45 Responders |
| A - Low Q7D | Proportion of Subjects Achieving ≥ 50% Decrease in Target Wound Area From Baseline Through Week 13 | Visit 7 | 39 Responders |
| A - Low Q7D | Proportion of Subjects Achieving ≥ 50% Decrease in Target Wound Area From Baseline Through Week 13 | Visit 3 | 29 Responders |
| A - Low Q7D | Proportion of Subjects Achieving ≥ 50% Decrease in Target Wound Area From Baseline Through Week 13 | Visit 8 | 43 Responders |
| A - Low Q7D | Proportion of Subjects Achieving ≥ 50% Decrease in Target Wound Area From Baseline Through Week 13 | Visit 2 | 17 Responders |
| A - Low Q7D | Proportion of Subjects Achieving ≥ 50% Decrease in Target Wound Area From Baseline Through Week 13 | Visit 12 | 42 Responders |
| A - Low Q7D | Proportion of Subjects Achieving ≥ 50% Decrease in Target Wound Area From Baseline Through Week 13 | Visit 4 | 34 Responders |
| A - Low Q7D | Proportion of Subjects Achieving ≥ 50% Decrease in Target Wound Area From Baseline Through Week 13 | Visit 9 | 43 Responders |
| A - Low Q7D | Proportion of Subjects Achieving ≥ 50% Decrease in Target Wound Area From Baseline Through Week 13 | Visit 11 | 44 Responders |
| A - Low Q7D | Proportion of Subjects Achieving ≥ 50% Decrease in Target Wound Area From Baseline Through Week 13 | Visit 5 | 38 Responders |
| A - Low Q7D | Proportion of Subjects Achieving ≥ 50% Decrease in Target Wound Area From Baseline Through Week 13 | Visit 10 | 40 Responders |
| A - Low Q7D | Proportion of Subjects Achieving ≥ 50% Decrease in Target Wound Area From Baseline Through Week 13 | Visit 6 | 40 Responders |
| D - High Q14D | Proportion of Subjects Achieving ≥ 50% Decrease in Target Wound Area From Baseline Through Week 13 | Visit 12 | 42 Responders |
| D - High Q14D | Proportion of Subjects Achieving ≥ 50% Decrease in Target Wound Area From Baseline Through Week 13 | Visit 2 | 5 Responders |
| D - High Q14D | Proportion of Subjects Achieving ≥ 50% Decrease in Target Wound Area From Baseline Through Week 13 | Visit 3 | 20 Responders |
| D - High Q14D | Proportion of Subjects Achieving ≥ 50% Decrease in Target Wound Area From Baseline Through Week 13 | Visit 4 | 23 Responders |
| D - High Q14D | Proportion of Subjects Achieving ≥ 50% Decrease in Target Wound Area From Baseline Through Week 13 | Visit 5 | 28 Responders |
| D - High Q14D | Proportion of Subjects Achieving ≥ 50% Decrease in Target Wound Area From Baseline Through Week 13 | Visit 6 | 32 Responders |
| D - High Q14D | Proportion of Subjects Achieving ≥ 50% Decrease in Target Wound Area From Baseline Through Week 13 | Visit 7 | 33 Responders |
| D - High Q14D | Proportion of Subjects Achieving ≥ 50% Decrease in Target Wound Area From Baseline Through Week 13 | Visit 8 | 38 Responders |
| D - High Q14D | Proportion of Subjects Achieving ≥ 50% Decrease in Target Wound Area From Baseline Through Week 13 | Visit 9 | 36 Responders |
| D - High Q14D | Proportion of Subjects Achieving ≥ 50% Decrease in Target Wound Area From Baseline Through Week 13 | Visit 10 | 38 Responders |
| D - High Q14D | Proportion of Subjects Achieving ≥ 50% Decrease in Target Wound Area From Baseline Through Week 13 | Visit 11 | 39 Responders |
| D - High Q14D | Proportion of Subjects Achieving ≥ 50% Decrease in Target Wound Area From Baseline Through Week 13 | Visit 13 | 40 Responders |
| C - High Q7D | Proportion of Subjects Achieving ≥ 50% Decrease in Target Wound Area From Baseline Through Week 13 | Visit 7 | 34 Responders |
| C - High Q7D | Proportion of Subjects Achieving ≥ 50% Decrease in Target Wound Area From Baseline Through Week 13 | Visit 2 | 6 Responders |
| C - High Q7D | Proportion of Subjects Achieving ≥ 50% Decrease in Target Wound Area From Baseline Through Week 13 | Visit 9 | 37 Responders |
| C - High Q7D | Proportion of Subjects Achieving ≥ 50% Decrease in Target Wound Area From Baseline Through Week 13 | Visit 6 | 31 Responders |
| C - High Q7D | Proportion of Subjects Achieving ≥ 50% Decrease in Target Wound Area From Baseline Through Week 13 | Visit 10 | 37 Responders |
| C - High Q7D | Proportion of Subjects Achieving ≥ 50% Decrease in Target Wound Area From Baseline Through Week 13 | Visit 5 | 27 Responders |
| C - High Q7D | Proportion of Subjects Achieving ≥ 50% Decrease in Target Wound Area From Baseline Through Week 13 | Visit 13 | 38 Responders |
| C - High Q7D | Proportion of Subjects Achieving ≥ 50% Decrease in Target Wound Area From Baseline Through Week 13 | Visit 11 | 39 Responders |
| C - High Q7D | Proportion of Subjects Achieving ≥ 50% Decrease in Target Wound Area From Baseline Through Week 13 | Visit 4 | 24 Responders |
| C - High Q7D | Proportion of Subjects Achieving ≥ 50% Decrease in Target Wound Area From Baseline Through Week 13 | Visit 3 | 20 Responders |
| C - High Q7D | Proportion of Subjects Achieving ≥ 50% Decrease in Target Wound Area From Baseline Through Week 13 | Visit 12 | 37 Responders |
| C - High Q7D | Proportion of Subjects Achieving ≥ 50% Decrease in Target Wound Area From Baseline Through Week 13 | Visit 8 | 35 Responders |
| E - HP802-247 Vehicle | Proportion of Subjects Achieving ≥ 50% Decrease in Target Wound Area From Baseline Through Week 13 | Visit 7 | 42 Responders |
| E - HP802-247 Vehicle | Proportion of Subjects Achieving ≥ 50% Decrease in Target Wound Area From Baseline Through Week 13 | Visit 11 | 43 Responders |
| E - HP802-247 Vehicle | Proportion of Subjects Achieving ≥ 50% Decrease in Target Wound Area From Baseline Through Week 13 | Visit 2 | 13 Responders |
| E - HP802-247 Vehicle | Proportion of Subjects Achieving ≥ 50% Decrease in Target Wound Area From Baseline Through Week 13 | Visit 9 | 41 Responders |
| E - HP802-247 Vehicle | Proportion of Subjects Achieving ≥ 50% Decrease in Target Wound Area From Baseline Through Week 13 | Visit 3 | 21 Responders |
| E - HP802-247 Vehicle | Proportion of Subjects Achieving ≥ 50% Decrease in Target Wound Area From Baseline Through Week 13 | Visit 5 | 34 Responders |
| E - HP802-247 Vehicle | Proportion of Subjects Achieving ≥ 50% Decrease in Target Wound Area From Baseline Through Week 13 | Visit 13 | 40 Responders |
| E - HP802-247 Vehicle | Proportion of Subjects Achieving ≥ 50% Decrease in Target Wound Area From Baseline Through Week 13 | Visit 6 | 36 Responders |
| E - HP802-247 Vehicle | Proportion of Subjects Achieving ≥ 50% Decrease in Target Wound Area From Baseline Through Week 13 | Visit 10 | 40 Responders |
| E - HP802-247 Vehicle | Proportion of Subjects Achieving ≥ 50% Decrease in Target Wound Area From Baseline Through Week 13 | Visit 8 | 41 Responders |
| E - HP802-247 Vehicle | Proportion of Subjects Achieving ≥ 50% Decrease in Target Wound Area From Baseline Through Week 13 | Visit 4 | 31 Responders |
| E - HP802-247 Vehicle | Proportion of Subjects Achieving ≥ 50% Decrease in Target Wound Area From Baseline Through Week 13 | Visit 12 | 41 Responders |
p-value: 0.0133Cochran-Mantel-Haenszel
p-value: 0.3839Cochran-Mantel-Haenszel
p-value: 0.5721Cochran-Mantel-Haenszel
p-value: 0.232Cochran-Mantel-Haenszel
p-value: 0.0787Cochran-Mantel-Haenszel
p-value: 0.7919Cochran-Mantel-Haenszel
p-value: 0.6881Cochran-Mantel-Haenszel
p-value: 0.9832Cochran-Mantel-Haenszel
p-value: 0.0466Cochran-Mantel-Haenszel
p-value: 0.8435Cochran-Mantel-Haenszel
p-value: 0.8743Cochran-Mantel-Haenszel
p-value: 0.2884Cochran-Mantel-Haenszel
p-value: 0.0387Cochran-Mantel-Haenszel
p-value: 0.8461Cochran-Mantel-Haenszel
p-value: 0.9574Cochran-Mantel-Haenszel
p-value: 0.2994Cochran-Mantel-Haenszel
p-value: 0.1024Cochran-Mantel-Haenszel
p-value: 0.8759Cochran-Mantel-Haenszel
p-value: 0.9008Cochran-Mantel-Haenszel
p-value: 0.4618Cochran-Mantel-Haenszel
p-value: 0.2439Cochran-Mantel-Haenszel
p-value: 0.749Cochran-Mantel-Haenszel
p-value: 0.3749Cochran-Mantel-Haenszel
p-value: 0.015Cochran-Mantel-Haenszel
p-value: 0.0078Cochran-Mantel-Haenszel
p-value: 0.07Cochran-Mantel-Haenszel
p-value: 0.208Cochran-Mantel-Haenszel
p-value: 0.0413Cochran-Mantel-Haenszel
p-value: 0.0054Cochran-Mantel-Haenszel
p-value: 0.2031Cochran-Mantel-Haenszel
p-value: 0.0894Cochran-Mantel-Haenszel
p-value: 0.0288Cochran-Mantel-Haenszel
p-value: 0.6964Cochran-Mantel-Haenszel
p-value: 0.59Cochran-Mantel-Haenszel
p-value: 0.7146Cochran-Mantel-Haenszel
p-value: 0.5008Cochran-Mantel-Haenszel
p-value: 0.1235Cochran-Mantel-Haenszel
p-value: 0.5488Cochran-Mantel-Haenszel
p-value: 0.4343Cochran-Mantel-Haenszel
p-value: 0.1114Cochran-Mantel-Haenszel
p-value: 0.2119Cochran-Mantel-Haenszel
p-value: 0.0194Cochran-Mantel-Haenszel
p-value: 0.506Cochran-Mantel-Haenszel
p-value: 0.2317Cochran-Mantel-Haenszel
p-value: 0.1144Cochran-Mantel-Haenszel
p-value: 0.6786Cochran-Mantel-Haenszel
p-value: 0.7735Cochran-Mantel-Haenszel
p-value: 0.758Cochran-Mantel-Haenszel
Secondary
Target Ulcer Pain Was Measured Using a Visual Analog Scale [Range: 0mm - 100mm]. Subjects Marked Their Pain Level on a 100 mm Horizontal Line, With a Short Vertical Line Across the Scale, 0 Denoting no Pain and 100mm the Maximum Pain.
Target ulcer pain was measured using a Visual Analog Scale \[Range: 0mm - 100mm\]. Subjects marked their pain level on a 100 mm horizontal line, with a short vertical line across the scale, 0 denoting no pain and 100mm the maximum pain. Each weekly measurement is reported as the average of all subjects scores at each week per treatment group.
Time frame: Weekly, over the 12 week treatment period
Population: ITT Populations: Subjects who received at least one dose of test article. Data were analyzed by an ANCOVA, adjusted for site and baseline score.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| B - Low Q14D | Target Ulcer Pain Was Measured Using a Visual Analog Scale [Range: 0mm - 100mm]. Subjects Marked Their Pain Level on a 100 mm Horizontal Line, With a Short Vertical Line Across the Scale, 0 Denoting no Pain and 100mm the Maximum Pain. | Week 09 | 9.3 units on a scale | Standard Deviation 14.96 |
| B - Low Q14D | Target Ulcer Pain Was Measured Using a Visual Analog Scale [Range: 0mm - 100mm]. Subjects Marked Their Pain Level on a 100 mm Horizontal Line, With a Short Vertical Line Across the Scale, 0 Denoting no Pain and 100mm the Maximum Pain. | Baseline | 30.82 units on a scale | Standard Deviation 31.22 |
| B - Low Q14D | Target Ulcer Pain Was Measured Using a Visual Analog Scale [Range: 0mm - 100mm]. Subjects Marked Their Pain Level on a 100 mm Horizontal Line, With a Short Vertical Line Across the Scale, 0 Denoting no Pain and 100mm the Maximum Pain. | Week 12 | 7.95 units on a scale | Standard Deviation 13.34 |
| B - Low Q14D | Target Ulcer Pain Was Measured Using a Visual Analog Scale [Range: 0mm - 100mm]. Subjects Marked Their Pain Level on a 100 mm Horizontal Line, With a Short Vertical Line Across the Scale, 0 Denoting no Pain and 100mm the Maximum Pain. | Week 03 | 21.68 units on a scale | Standard Deviation 25.01 |
| B - Low Q14D | Target Ulcer Pain Was Measured Using a Visual Analog Scale [Range: 0mm - 100mm]. Subjects Marked Their Pain Level on a 100 mm Horizontal Line, With a Short Vertical Line Across the Scale, 0 Denoting no Pain and 100mm the Maximum Pain. | Week 06 | 10.72 units on a scale | Standard Deviation 18.22 |
| A - Low Q7D | Target Ulcer Pain Was Measured Using a Visual Analog Scale [Range: 0mm - 100mm]. Subjects Marked Their Pain Level on a 100 mm Horizontal Line, With a Short Vertical Line Across the Scale, 0 Denoting no Pain and 100mm the Maximum Pain. | Week 09 | 8.85 units on a scale | Standard Deviation 18.53 |
| A - Low Q7D | Target Ulcer Pain Was Measured Using a Visual Analog Scale [Range: 0mm - 100mm]. Subjects Marked Their Pain Level on a 100 mm Horizontal Line, With a Short Vertical Line Across the Scale, 0 Denoting no Pain and 100mm the Maximum Pain. | Week 06 | 10.35 units on a scale | Standard Deviation 20.43 |
| A - Low Q7D | Target Ulcer Pain Was Measured Using a Visual Analog Scale [Range: 0mm - 100mm]. Subjects Marked Their Pain Level on a 100 mm Horizontal Line, With a Short Vertical Line Across the Scale, 0 Denoting no Pain and 100mm the Maximum Pain. | Week 03 | 13.37 units on a scale | Standard Deviation 18.61 |
| A - Low Q7D | Target Ulcer Pain Was Measured Using a Visual Analog Scale [Range: 0mm - 100mm]. Subjects Marked Their Pain Level on a 100 mm Horizontal Line, With a Short Vertical Line Across the Scale, 0 Denoting no Pain and 100mm the Maximum Pain. | Week 12 | 6.83 units on a scale | Standard Deviation 11.72 |
| A - Low Q7D | Target Ulcer Pain Was Measured Using a Visual Analog Scale [Range: 0mm - 100mm]. Subjects Marked Their Pain Level on a 100 mm Horizontal Line, With a Short Vertical Line Across the Scale, 0 Denoting no Pain and 100mm the Maximum Pain. | Baseline | 21.11 units on a scale | Standard Deviation 25.23 |
| D - High Q14D | Target Ulcer Pain Was Measured Using a Visual Analog Scale [Range: 0mm - 100mm]. Subjects Marked Their Pain Level on a 100 mm Horizontal Line, With a Short Vertical Line Across the Scale, 0 Denoting no Pain and 100mm the Maximum Pain. | Week 06 | 7.35 units on a scale | Standard Deviation 13.36 |
| D - High Q14D | Target Ulcer Pain Was Measured Using a Visual Analog Scale [Range: 0mm - 100mm]. Subjects Marked Their Pain Level on a 100 mm Horizontal Line, With a Short Vertical Line Across the Scale, 0 Denoting no Pain and 100mm the Maximum Pain. | Baseline | 28.6 units on a scale | Standard Deviation 21.77 |
| D - High Q14D | Target Ulcer Pain Was Measured Using a Visual Analog Scale [Range: 0mm - 100mm]. Subjects Marked Their Pain Level on a 100 mm Horizontal Line, With a Short Vertical Line Across the Scale, 0 Denoting no Pain and 100mm the Maximum Pain. | Week 03 | 16.87 units on a scale | Standard Deviation 19.22 |
| D - High Q14D | Target Ulcer Pain Was Measured Using a Visual Analog Scale [Range: 0mm - 100mm]. Subjects Marked Their Pain Level on a 100 mm Horizontal Line, With a Short Vertical Line Across the Scale, 0 Denoting no Pain and 100mm the Maximum Pain. | Week 09 | 4.53 units on a scale | Standard Deviation 9.54 |
| D - High Q14D | Target Ulcer Pain Was Measured Using a Visual Analog Scale [Range: 0mm - 100mm]. Subjects Marked Their Pain Level on a 100 mm Horizontal Line, With a Short Vertical Line Across the Scale, 0 Denoting no Pain and 100mm the Maximum Pain. | Week 12 | 3.28 units on a scale | Standard Deviation 6.83 |
| C - High Q7D | Target Ulcer Pain Was Measured Using a Visual Analog Scale [Range: 0mm - 100mm]. Subjects Marked Their Pain Level on a 100 mm Horizontal Line, With a Short Vertical Line Across the Scale, 0 Denoting no Pain and 100mm the Maximum Pain. | Week 12 | 13.22 units on a scale | Standard Deviation 20.71 |
| C - High Q7D | Target Ulcer Pain Was Measured Using a Visual Analog Scale [Range: 0mm - 100mm]. Subjects Marked Their Pain Level on a 100 mm Horizontal Line, With a Short Vertical Line Across the Scale, 0 Denoting no Pain and 100mm the Maximum Pain. | Baseline | 29.84 units on a scale | Standard Deviation 26.36 |
| C - High Q7D | Target Ulcer Pain Was Measured Using a Visual Analog Scale [Range: 0mm - 100mm]. Subjects Marked Their Pain Level on a 100 mm Horizontal Line, With a Short Vertical Line Across the Scale, 0 Denoting no Pain and 100mm the Maximum Pain. | Week 09 | 11.51 units on a scale | Standard Deviation 18.29 |
| C - High Q7D | Target Ulcer Pain Was Measured Using a Visual Analog Scale [Range: 0mm - 100mm]. Subjects Marked Their Pain Level on a 100 mm Horizontal Line, With a Short Vertical Line Across the Scale, 0 Denoting no Pain and 100mm the Maximum Pain. | Week 06 | 12.25 units on a scale | Standard Deviation 17.96 |
| C - High Q7D | Target Ulcer Pain Was Measured Using a Visual Analog Scale [Range: 0mm - 100mm]. Subjects Marked Their Pain Level on a 100 mm Horizontal Line, With a Short Vertical Line Across the Scale, 0 Denoting no Pain and 100mm the Maximum Pain. | Week 03 | 18.81 units on a scale | Standard Deviation 22.15 |
| E - HP802-247 Vehicle | Target Ulcer Pain Was Measured Using a Visual Analog Scale [Range: 0mm - 100mm]. Subjects Marked Their Pain Level on a 100 mm Horizontal Line, With a Short Vertical Line Across the Scale, 0 Denoting no Pain and 100mm the Maximum Pain. | Week 06 | 11.61 units on a scale | Standard Deviation 19.03 |
| E - HP802-247 Vehicle | Target Ulcer Pain Was Measured Using a Visual Analog Scale [Range: 0mm - 100mm]. Subjects Marked Their Pain Level on a 100 mm Horizontal Line, With a Short Vertical Line Across the Scale, 0 Denoting no Pain and 100mm the Maximum Pain. | Week 09 | 7.01 units on a scale | Standard Deviation 13.63 |
| E - HP802-247 Vehicle | Target Ulcer Pain Was Measured Using a Visual Analog Scale [Range: 0mm - 100mm]. Subjects Marked Their Pain Level on a 100 mm Horizontal Line, With a Short Vertical Line Across the Scale, 0 Denoting no Pain and 100mm the Maximum Pain. | Baseline | 25.47 units on a scale | Standard Deviation 27.7 |
| E - HP802-247 Vehicle | Target Ulcer Pain Was Measured Using a Visual Analog Scale [Range: 0mm - 100mm]. Subjects Marked Their Pain Level on a 100 mm Horizontal Line, With a Short Vertical Line Across the Scale, 0 Denoting no Pain and 100mm the Maximum Pain. | Week 12 | 6.61 units on a scale | Standard Deviation 13.43 |
| E - HP802-247 Vehicle | Target Ulcer Pain Was Measured Using a Visual Analog Scale [Range: 0mm - 100mm]. Subjects Marked Their Pain Level on a 100 mm Horizontal Line, With a Short Vertical Line Across the Scale, 0 Denoting no Pain and 100mm the Maximum Pain. | Week 03 | 14.42 units on a scale | Standard Deviation 18.17 |