Diabetic Foot Ulcers, Venous Leg Ulcers
Conditions
Keywords
Venous leg ulcer, ulcer, venous stasis, compression, diabetic foot ulcers, dfu, vlu
Brief summary
The aim of this study is to compare the clinical efficacy of two types of NPWT systems; the traditional negative pressure wound therapy (tNPWT) system and the single-use negative pressure wound therapy (PICO) system.
Detailed description
The two types of NPWT systems include the tNPWT system that has successfully completed a coding verification request with CMS and has the following capabilities (e.g., range of negative pressure, connective tubing, canister, foam or gauze filler, and approved for home use), and a portable, canister-less, battery operated, disposable PICO system to see if there are any observed differences with regard to the clinical efficacy of the two devices.
Interventions
DEVICEPICO System
Negative Pressure Wound Therapy (NPWT) at 80mmHg (nominal) +/- 20 mmHg to the wound surface
DEVICEtNPWT System
NPWT from -25 mmHg and up to -200 mmHg; intensity settings of either low, medium and high; delivery modes of continuous or intermittent. The pressure, intensity and delivery settings will be left to the Investigator's discretion at each study treatment visit.
Sponsors
Smith & Nephew, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Provide informed consent * Age ≥ 18 years and of either sex * Willing to comply with protocol instructions, including allowing all study assessments * Have a Venous Leg Ulcer (VLU) between the knee and ankle (at or above the malleolus), with a surface area ≥ 2.0 cm2 and ≤ 36.0 cm2 * Target ulcer duration ≥ 4 weeks but ≤ 104 weeks (24 months) * Have a Diabetic Foot Ulcer (DFU) present on any part of the plantar or dorsum surface of the foot, with a surface area ≥ 0.5 cm2 and ≤ 10.0 cm2 * Target ulcer involves a full thickness skin loss, but WITHOUT exposure of tendon, muscle, or bone * Target ulcer duration ≥ 4 weeks but ≤ 52 weeks (12 months) * Acceptable state of health and nutrition
Exclusion criteria
* Therapy with another investigational agent within thirty (30) days of Screening, or during the study Ulcers which are deemed as highly exuding, per the Investigator's discretion. * Current diagnosis of osteomyelitis at the target wound location that is not currently receiving treatment \[Documented history of resolved osteomyelitis is allowed\]. * Subjects with a VLU: Refusal of or inability to tolerate compression therapy. * Clinical evidence of target ulcer infection * Current systemic therapy with cytotoxic drugs. * Current therapy with chronic (\> 10 days) oral corticosteroids. * Previous treatment with NPWT device or hyperbaric oxygen within 7 days of screening. * Malignancy in the target ulcer, or history of cancer in the preceding 5 years (other than carcinoma in situ of the cervix or adequately treated non-melanoma skin cancers)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Ulcer Area From Baseline to the End of the Treatment Period | Baseline through 12 weeks | Ulcer area was photographed in order to determine the measurements of the post-debridement ulcer area (cm\^2 and total percentage \[%\]) using the ARANZ Silhouette wound imaging and measurement device. |
| Percentage Change in Ulcer Area From Baseline to the End of the Treatment Period | Baseline through 12 weeks | Ulcer area was photographed in order to determine the measurements of the postdebridement ulcer area (cm\^2 and total percentage \[%\]) using the ARANZ Silhouette wound imaging and measurement device. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Target Ulcer Depth Following Treatment With Either PICO or tNPWT From Baseline Over the 12-week Treatment Period | Baseline through 12 weeks | Ulcer area was analyzed for depth measurement in millimeters (mm), volume measurement in cubic centimeters (cm\^3), and percentage change (%) including terms for treatment, baseline depth, baseline volume, wound type, pooled sites, and wound duration using the ARANZ Silhouette wound imaging and measurement device. |
| Change in Target Ulcer Volume Following Treatment With Either PICO or tNPWT From Baseline Over the 12-week Treatment Period | Baseline through 12 weeks | Ulcer area was analyzed for depth measurement in millimeters (mm), volume measurement in cubic centimeters (cm\^3), and percentage change (%) including terms for treatment, baseline depth, baseline volume, wound type, pooled sites, and wound duration using the ARANZ Silhouette wound imaging and measurement device. |
| Percentage Change in Target Ulcer Depth and Volume Following Treatment With Either PICO or tNPWT From Baseline Over the 12-week Treatment Period | Baseline through 12 weeks | Ulcer area was analyzed for depth measurement in millimeters (mm), volume measurement in cubic centimeters (cm\^3), and percentage change (%) including terms for treatment, baseline depth, baseline volume, wound type, pooled sites, and wound duration using the ARANZ Silhouette wound imaging and measurement device. |
Countries
Canada, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| PICO System Subjects randomized to receive the PICO system applied to the target ulcer area over the 12-week treatment period from Baseline. | 80 |
| tNPWT System Subjects randomized to receive the tNPWT system applied to the target ulcer area over the 12-week treatment period from Baseline. | 81 |
| Total | 161 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 5 | 2 |
| Overall Study | Lack of Efficacy | 5 | 15 |
| Overall Study | Lost to Follow-up | 1 | 1 |
| Overall Study | Physician Decision | 0 | 3 |
| Overall Study | Protocol Violation | 4 | 11 |
| Overall Study | Withdrawal by Subject | 3 | 10 |
Baseline characteristics
| Characteristic | PICO System | tNPWT System | Total |
|---|---|---|---|
| Age, Continuous | 62.5 years STANDARD_DEVIATION 14.7 | 60.4 years STANDARD_DEVIATION 11.9 | 61.5 years STANDARD_DEVIATION 13.4 |
| BMI (kg/m^2) | 33.7 kg/m^2 STANDARD_DEVIATION 8.8 | 33.9 kg/m^2 STANDARD_DEVIATION 9 | 33.8 kg/m^2 STANDARD_DEVIATION 8.9 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 77 Participants | 79 Participants | 156 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 3 Participants | 2 Participants | 5 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 2 Participants | 0 Participants | 2 Participants |
| Race (NIH/OMB) Black or African American | 8 Participants | 12 Participants | 20 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 3 Participants | 2 Participants | 5 Participants |
| Race (NIH/OMB) White | 67 Participants | 67 Participants | 134 Participants |
| Region of Enrollment Canada | 2 participants | 5 participants | 7 participants |
| Region of Enrollment United States | 78 participants | 76 participants | 154 participants |
| Sex: Female, Male Female | 32 Participants | 27 Participants | 59 Participants |
| Sex: Female, Male Male | 48 Participants | 54 Participants | 102 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 2 / 80 | 0 / 84 |
| other Total, other adverse events | 65 / 80 | 57 / 84 |
| serious Total, serious adverse events | 6 / 80 | 8 / 84 |
Outcome results
Primary
Change in Ulcer Area From Baseline to the End of the Treatment Period
Ulcer area was photographed in order to determine the measurements of the post-debridement ulcer area (cm\^2 and total percentage \[%\]) using the ARANZ Silhouette wound imaging and measurement device.
Time frame: Baseline through 12 weeks
Population: The Per-Protocol (PP) population was used to analyze outcome measure data and included all subjects who were randomized, met inclusion/exclusion criteria, had not discontinued treatment within the first 9 weeks (-1 day), and had no significant protocol deviations.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| PICO System | Change in Ulcer Area From Baseline to the End of the Treatment Period | Baseline wound area | 6.2 cm^2 | Standard Deviation 5.9 |
| PICO System | Change in Ulcer Area From Baseline to the End of the Treatment Period | Final wound area | 0.7 cm^2 | Standard Deviation 1.8 |
| PICO System | Change in Ulcer Area From Baseline to the End of the Treatment Period | Change in wound area | -5.5 cm^2 | Standard Deviation 5.4 |
| tNPWT System | Change in Ulcer Area From Baseline to the End of the Treatment Period | Baseline wound area | 7.8 cm^2 | Standard Deviation 6.3 |
| tNPWT System | Change in Ulcer Area From Baseline to the End of the Treatment Period | Final wound area | 3.8 cm^2 | Standard Deviation 6.7 |
| tNPWT System | Change in Ulcer Area From Baseline to the End of the Treatment Period | Change in wound area | -4.0 cm^2 | Standard Deviation 6.2 |
Comparison: Percentage change in wound area from Baseline to end of 12-week treatment period (PP population - all wounds)p-value: 0.001Stepwise regression
Primary
Percentage Change in Ulcer Area From Baseline to the End of the Treatment Period
Ulcer area was photographed in order to determine the measurements of the postdebridement ulcer area (cm\^2 and total percentage \[%\]) using the ARANZ Silhouette wound imaging and measurement device.
Time frame: Baseline through 12 weeks
Population: The Per-Protocol (PP) population was used to analyze outcome measure data and included all subjects who were randomized, met inclusion/exclusion criteria, had not discontinued treatment within the first 9 weeks (-1 day), and had no significant protocol deviations.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| PICO System | Percentage Change in Ulcer Area From Baseline to the End of the Treatment Period | -88.7 Percentage of change in wound area | Standard Deviation 24.1 |
| tNPWT System | Percentage Change in Ulcer Area From Baseline to the End of the Treatment Period | -58.6 Percentage of change in wound area | Standard Deviation 63.5 |
Secondary
Change in Target Ulcer Depth Following Treatment With Either PICO or tNPWT From Baseline Over the 12-week Treatment Period
Ulcer area was analyzed for depth measurement in millimeters (mm), volume measurement in cubic centimeters (cm\^3), and percentage change (%) including terms for treatment, baseline depth, baseline volume, wound type, pooled sites, and wound duration using the ARANZ Silhouette wound imaging and measurement device.
Time frame: Baseline through 12 weeks
Population: Change in wound depth over 12-week treatment period by treatment group (PP population - all wounds)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| PICO System | Change in Target Ulcer Depth Following Treatment With Either PICO or tNPWT From Baseline Over the 12-week Treatment Period | Baseline wound depth | 4.0 mm | Standard Deviation 6.8 |
| PICO System | Change in Target Ulcer Depth Following Treatment With Either PICO or tNPWT From Baseline Over the 12-week Treatment Period | Final wound depth | 0.6 mm | Standard Deviation 1.1 |
| PICO System | Change in Target Ulcer Depth Following Treatment With Either PICO or tNPWT From Baseline Over the 12-week Treatment Period | Change in wound depth | -3.4 mm | Standard Deviation 7.1 |
| tNPWT System | Change in Target Ulcer Depth Following Treatment With Either PICO or tNPWT From Baseline Over the 12-week Treatment Period | Baseline wound depth | 2.4 mm | Standard Deviation 1.3 |
| tNPWT System | Change in Target Ulcer Depth Following Treatment With Either PICO or tNPWT From Baseline Over the 12-week Treatment Period | Final wound depth | 1.5 mm | Standard Deviation 2.1 |
| tNPWT System | Change in Target Ulcer Depth Following Treatment With Either PICO or tNPWT From Baseline Over the 12-week Treatment Period | Change in wound depth | -0.9 mm | Standard Deviation 1.9 |
Secondary
Change in Target Ulcer Volume Following Treatment With Either PICO or tNPWT From Baseline Over the 12-week Treatment Period
Ulcer area was analyzed for depth measurement in millimeters (mm), volume measurement in cubic centimeters (cm\^3), and percentage change (%) including terms for treatment, baseline depth, baseline volume, wound type, pooled sites, and wound duration using the ARANZ Silhouette wound imaging and measurement device.
Time frame: Baseline through 12 weeks
Population: Change in wound volume over 12-week treatment period by treatment group (PP population - all wounds)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| PICO System | Change in Target Ulcer Volume Following Treatment With Either PICO or tNPWT From Baseline Over the 12-week Treatment Period | Baseline wound volume | 0.3 cm^3 | Standard Deviation 0.3 |
| PICO System | Change in Target Ulcer Volume Following Treatment With Either PICO or tNPWT From Baseline Over the 12-week Treatment Period | Final wound volume | 0.2 cm^3 | Standard Deviation 0.5 |
| PICO System | Change in Target Ulcer Volume Following Treatment With Either PICO or tNPWT From Baseline Over the 12-week Treatment Period | Change in wound volume | -0.3 cm^3 | Standard Deviation 0.3 |
| tNPWT System | Change in Target Ulcer Volume Following Treatment With Either PICO or tNPWT From Baseline Over the 12-week Treatment Period | Baseline wound volume | 0.3 cm^3 | Standard Deviation 0.3 |
| tNPWT System | Change in Target Ulcer Volume Following Treatment With Either PICO or tNPWT From Baseline Over the 12-week Treatment Period | Final wound volume | 0.1 cm^3 | Standard Deviation 0.3 |
| tNPWT System | Change in Target Ulcer Volume Following Treatment With Either PICO or tNPWT From Baseline Over the 12-week Treatment Period | Change in wound volume | 0 cm^3 | Standard Deviation 0.4 |
Secondary
Percentage Change in Target Ulcer Depth and Volume Following Treatment With Either PICO or tNPWT From Baseline Over the 12-week Treatment Period
Ulcer area was analyzed for depth measurement in millimeters (mm), volume measurement in cubic centimeters (cm\^3), and percentage change (%) including terms for treatment, baseline depth, baseline volume, wound type, pooled sites, and wound duration using the ARANZ Silhouette wound imaging and measurement device.
Time frame: Baseline through 12 weeks
Population: Percentage change in wound depth and volume over 12-week treatment period by treatment group (PP population - all wounds)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| PICO System | Percentage Change in Target Ulcer Depth and Volume Following Treatment With Either PICO or tNPWT From Baseline Over the 12-week Treatment Period | Percentage change from baseline in wound depth | -68.8 percent change | Standard Deviation 59.4 |
| PICO System | Percentage Change in Target Ulcer Depth and Volume Following Treatment With Either PICO or tNPWT From Baseline Over the 12-week Treatment Period | Percentage change from baseline in wound volume | -98.0 percent change | Standard Deviation 8.1 |
| tNPWT System | Percentage Change in Target Ulcer Depth and Volume Following Treatment With Either PICO or tNPWT From Baseline Over the 12-week Treatment Period | Percentage change from baseline in wound depth | -38.8 percent change | Standard Deviation 71.3 |
| tNPWT System | Percentage Change in Target Ulcer Depth and Volume Following Treatment With Either PICO or tNPWT From Baseline Over the 12-week Treatment Period | Percentage change from baseline in wound volume | -10.1 percent change | Standard Deviation 207.8 |