Venous Leg Ulcer, Venous Stasis Ulcer
Conditions
Keywords
Venous Leg Ulcer, Venous Stasis Ulcer, VLU, VSU, Leg Ulcer, Leg Wound
Brief summary
This is a 24-week observational follow safety study for Study 802-247-09-015.
Detailed description
The objective of this study is to examine the durability of previous target wound closures, identify new test article-related adverse events, record new target wound closures, and examine ongoing adverse events not resolved in subjects who participated in HP 802-247-09-015.
Interventions
BIOLOGICALNo HP802 Treatment
OTHERNo HP802 Vehicle Treatment
Sponsors
Healthpoint
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
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. * Subject was randomized in HP 802-247-09-015 and received at least one application of a test article, whether active or placebo. * Subject has ended their participation in HP 802-247-09-015 by virtue of completing the study, or by dropping out prior to completion.
Exclusion criteria
* Subjects who refuse to provide written informed consent will be excluded from this trial.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The Number of Participants With Closed Target Ulcers at Each Visit | Over the 24-week study period, at each of the bi-monthly visits | At each visit the status of closed target ulcers was evaluated as remained closed or re-opened. |
| Number of Subjects With Target Wound Closed for the First Time During the Study Period. | Over the 24-week study period, at each of the bi-monthly visits | At each visit the status of open target ulcers was evaluated as remained open or closed. |
Countries
Canada, United States
Participant flow
Recruitment details
Eligible subjects were those who completed study 802-247-09-015. Of the 228 subjects who completed 802-247-09-015, 206 consented to enter this safety follow up study, between June 1, 2009 and October, 20, 2011.
Pre-assignment details
Both PIs and subjects remained blinded to the therapy each subject received in 802-247-09-015. No test article was administered during this study and any therapy was at the discretion of the PI, with no restrictions.
Participants by arm
| Arm | Count |
|---|---|
| HP802-247 Vehicle Acellular vehicle applied weekly | 44 |
| LD-Q14D LD-Q14D: 0.5 x 106 cell/mL applied to wound surface every 2 weeks | 38 |
| LD-Q7D LD-Q7D: 0.5 x 106 cell/mL applied to wound surface every week | 41 |
| HD-Q14D HD-Q14D: 5.0 x 106 cell/mL applied to wound surface every 2 weeks | 41 |
| HD-Q7D HD-Q7D: 5.0 x 106 cell/mL applied to wound surface every week | 42 |
| Total | 206 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 |
|---|---|---|---|---|---|---|
| Overall Study | Adverse Event | 0 | 0 | 1 | 1 | 1 |
| Overall Study | Death | 1 | 0 | 0 | 1 | 0 |
| Overall Study | Lost to Follow-up | 0 | 2 | 1 | 4 | 4 |
| Overall Study | Withdrawal by Subject | 2 | 2 | 1 | 1 | 1 |
Baseline characteristics
| Characteristic | HP802-247 Vehicle | LD-Q14D | LD-Q7D | HD-Q14D | HD-Q7D | Total |
|---|---|---|---|---|---|---|
| Age, Customized 18-39 years | 1 participants | 4 participants | 3 participants | 3 participants | 4 participants | 15 participants |
| Age, Customized 40-49 years | 8 participants | 6 participants | 4 participants | 6 participants | 6 participants | 30 participants |
| Age, Customized 50-59 years | 11 participants | 7 participants | 10 participants | 8 participants | 6 participants | 42 participants |
| Age, Customized 60+ years | 24 participants | 21 participants | 24 participants | 24 participants | 26 participants | 119 participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 9 Participants | 11 Participants | 10 Participants | 6 Participants | 12 Participants | 48 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 35 Participants | 27 Participants | 31 Participants | 35 Participants | 30 Participants | 158 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 | 8 Participants | 9 Participants | 11 Participants | 8 Participants | 45 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 | 1 Participants | 4 Participants | 1 Participants | 3 Participants | 12 Participants |
| Race (NIH/OMB) White | 31 Participants | 29 Participants | 28 Participants | 29 Participants | 30 Participants | 147 Participants |
| Sex: Female, Male Female | 15 Participants | 17 Participants | 13 Participants | 19 Participants | 20 Participants | 84 Participants |
| Sex: Female, Male Male | 29 Participants | 21 Participants | 28 Participants | 22 Participants | 22 Participants | 122 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 | 10 / 38 | 6 / 41 | 5 / 41 | 11 / 42 | 14 / 44 |
| serious Total, serious adverse events | 3 / 38 | 0 / 41 | 4 / 41 | 5 / 42 | 4 / 44 |
Outcome results
Primary
Number of Subjects With Target Wound Closed for the First Time During the Study Period.
At each visit the status of open target ulcers was evaluated as remained open or closed.
Time frame: Over the 24-week study period, at each of the bi-monthly visits
Population: Subjects who completed the 802-247-09-015 study with open target wound attended three bimonthly visits over the duration of the study.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| LD-Q14D | Number of Subjects With Target Wound Closed for the First Time During the Study Period. | Month 2 (Visit 1) | 3 participants |
| LD-Q14D | Number of Subjects With Target Wound Closed for the First Time During the Study Period. | Month 6 (Visit 3) | 4 participants |
| LD-Q14D | Number of Subjects With Target Wound Closed for the First Time During the Study Period. | Month 4 (Visit 2) | 5 participants |
| LD-Q7D | Number of Subjects With Target Wound Closed for the First Time During the Study Period. | Month 4 (Visit 2) | 3 participants |
| LD-Q7D | Number of Subjects With Target Wound Closed for the First Time During the Study Period. | Month 2 (Visit 1) | 1 participants |
| LD-Q7D | Number of Subjects With Target Wound Closed for the First Time During the Study Period. | Month 6 (Visit 3) | 4 participants |
| HD-Q14D | Number of Subjects With Target Wound Closed for the First Time During the Study Period. | Month 4 (Visit 2) | 4 participants |
| HD-Q14D | Number of Subjects With Target Wound Closed for the First Time During the Study Period. | Month 2 (Visit 1) | 4 participants |
| HD-Q14D | Number of Subjects With Target Wound Closed for the First Time During the Study Period. | Month 6 (Visit 3) | 7 participants |
| HD-Q7D | Number of Subjects With Target Wound Closed for the First Time During the Study Period. | Month 2 (Visit 1) | 2 participants |
| HD-Q7D | Number of Subjects With Target Wound Closed for the First Time During the Study Period. | Month 6 (Visit 3) | 6 participants |
| HD-Q7D | Number of Subjects With Target Wound Closed for the First Time During the Study Period. | Month 4 (Visit 2) | 5 participants |
| HP802-247 Vehicle | Number of Subjects With Target Wound Closed for the First Time During the Study Period. | Month 4 (Visit 2) | 8 participants |
| HP802-247 Vehicle | Number of Subjects With Target Wound Closed for the First Time During the Study Period. | Month 2 (Visit 1) | 4 participants |
| HP802-247 Vehicle | Number of Subjects With Target Wound Closed for the First Time During the Study Period. | Month 6 (Visit 3) | 7 participants |
Primary
The Number of Participants With Closed Target Ulcers at Each Visit
At each visit the status of closed target ulcers was evaluated as remained closed or re-opened.
Time frame: Over the 24-week study period, at each of the bi-monthly visits
Population: Subjects who completed the 802-247-09-015 study with a closed target wound attended three bimonthly visits.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| LD-Q14D | The Number of Participants With Closed Target Ulcers at Each Visit | Enrollment | 27 participants |
| LD-Q14D | The Number of Participants With Closed Target Ulcers at Each Visit | Month 2 (Visit 1) | 22 participants |
| LD-Q14D | The Number of Participants With Closed Target Ulcers at Each Visit | Month 4 (Visit 2) | 25 participants |
| LD-Q14D | The Number of Participants With Closed Target Ulcers at Each Visit | Month 6 (Visit 3) | 25 participants |
| LD-Q7D | The Number of Participants With Closed Target Ulcers at Each Visit | Enrollment | 21 participants |
| LD-Q7D | The Number of Participants With Closed Target Ulcers at Each Visit | Month 6 (Visit 3) | 19 participants |
| LD-Q7D | The Number of Participants With Closed Target Ulcers at Each Visit | Month 2 (Visit 1) | 19 participants |
| LD-Q7D | The Number of Participants With Closed Target Ulcers at Each Visit | Month 4 (Visit 2) | 19 participants |
| HD-Q14D | The Number of Participants With Closed Target Ulcers at Each Visit | Month 6 (Visit 3) | 21 participants |
| HD-Q14D | The Number of Participants With Closed Target Ulcers at Each Visit | Month 2 (Visit 1) | 24 participants |
| HD-Q14D | The Number of Participants With Closed Target Ulcers at Each Visit | Month 4 (Visit 2) | 22 participants |
| HD-Q14D | The Number of Participants With Closed Target Ulcers at Each Visit | Enrollment | 25 participants |
| HD-Q7D | The Number of Participants With Closed Target Ulcers at Each Visit | Enrollment | 23 participants |
| HD-Q7D | The Number of Participants With Closed Target Ulcers at Each Visit | Month 2 (Visit 1) | 20 participants |
| HD-Q7D | The Number of Participants With Closed Target Ulcers at Each Visit | Month 6 (Visit 3) | 20 participants |
| HD-Q7D | The Number of Participants With Closed Target Ulcers at Each Visit | Month 4 (Visit 2) | 21 participants |
| HP802-247 Vehicle | The Number of Participants With Closed Target Ulcers at Each Visit | Month 6 (Visit 3) | 15 participants |
| HP802-247 Vehicle | The Number of Participants With Closed Target Ulcers at Each Visit | Month 4 (Visit 2) | 16 participants |
| HP802-247 Vehicle | The Number of Participants With Closed Target Ulcers at Each Visit | Month 2 (Visit 1) | 17 participants |
| HP802-247 Vehicle | The Number of Participants With Closed Target Ulcers at Each Visit | Enrollment | 18 participants |