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NCT01327937 · ClinicalTrials.gov registry record · Phase 4
A Post Marketing Study of Apligraf in Non-healing Wounds of Subjects With Venous Leg Ulcers
A Phase 4 study of Venous Ulcer, sponsored by Organogenesis.
- Completed
- Registry status
- Phase 4
- Development phase
- 30
- Enrollment target
- 1
- Study location
NCT01327937: Completed Phase 4 study of Venous Ulcer, sponsored by Organogenesis.
NCT01327937 is a Phase 4 study of Venous Ulcer that has completed, run by Organogenesis. The registered enrollment target is 30 participants, below the 157-participant average among 11 other Venous Ulcer trials with a reported enrollment target (81% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01327937, a Phase 4 study of Venous Ulcer, has completed, sponsored by Organogenesis.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 30 participants
- Enrollment target
- 1
- Study location
Study Summary
The overall study objective is to use microarray technology to identify and characterize the gene expression of multiple relevant genes in biopsies of non-healing venous ulcers.
Primary Outcome
Not Predicted to Heal (NPTH) defined as \<40% reduction in ulcer surface area from Day 0 to Week 4
Conditions Studied
Interventions
- DEVICE Apligraf
- OTHER Standard of Care Dressing Group
Study Locations (1)
Florida
- University of Miami - Miami
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2011-03 |
| Est. Completion | 2013-12 |
| Phase | Phase 4 |
What the finished NCT01327937 record still lists
NCT01327937 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 30 participants, a relatively small participant target, below the 157-participant average among 11 other Venous Ulcer trials with a reported enrollment target (81% lower).
The record links to 1 condition, with Venous Ulcer appearing as the primary indexed condition, and to 2 interventions - of which Apligraf is the first listed.
NCT01327937 reports a single indexed study location in Florida.
Frequently Asked Questions
What is clinical trial NCT01327937 about?
NCT01327937 is a clinical study titled "A Post Marketing Study of Apligraf in Non-healing Wounds of Subjects With Venous Leg Ulcers". The overall study objective is to use microarray technology to identify and characterize the gene expression of multiple relevant genes in biopsies of non-healing venous ulcers.
What is the current status of trial NCT01327937?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 30 participants. The study started on 2011-03. Estimated completion is 2013-12.
What conditions does trial NCT01327937 study?
This clinical trial studies the following conditions: Venous Ulcer.
What interventions are being tested in trial NCT01327937?
The interventions under investigation include: Apligraf (DEVICE), Standard of Care Dressing Group (OTHER).
Who is sponsoring clinical trial NCT01327937?
This trial is sponsored by Organogenesis, which has 20 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01327937 being conducted?
This trial has 1 study location across Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Venous Ulcer
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT01327937's enrollment target sits among peer trials
30 11th of 11 higher than 1 of 11 other Venous Ulcer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Venous Ulcer trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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