N/A
N=206
Safety Follow-Up to HP 802-247-09-015
Venous Leg Ulcer · Venous Stasis Ulcer
Bottom Line
View on ClinicalTrials.gov: NCT00900029 ↗Enrolled (actual)
206
Serious AEs
7.8%
Results posted
Sep 2016
Primary outcome: Primary: The Number of Participants With Closed Target Ulcers at Each Visit — 27; 21; 25; 23 participants
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- No HP802 Treatment (Biological); No HP802 Vehicle Treatment (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Healthpoint
- Primary completion
- Oct 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY The Number of Participants With Closed Target Ulcers at Each Visit |
27; 21; 25; 23; 18; 22 | — |
| PRIMARY Number of Subjects With Target Wound Closed for the First Time During the Study Period. |
3; 1; 4; 2; 4; 5 | — |
Summary
This is a 24-week observational follow safety study for Study 802-247-09-015.
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT00900029). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.