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NCT01970163 · ClinicalTrials.gov registry record · NA
DermACELL in Subjects With Chronic Wounds of the Lower Extremities
A NA study of Diabetic Foot Ulcer, sponsored by LifeNet Health.
- Completed
- Registry status
- NA
- Development phase
- 202
- Enrollment target
- 12
- Study locations
NCT01970163: Completed NA study of Diabetic Foot Ulcer, sponsored by LifeNet Health.
NCT01970163 is a NA study of Diabetic Foot Ulcer that has completed, run by LifeNet Health. The registered enrollment target is 202 participants, below the 252-participant average among 67 other Diabetic Foot Ulcer trials with a reported enrollment target (20% lower). The trial reports 12 study locations across 8 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01970163, a NA study of Diabetic Foot Ulcer, has completed, sponsored by LifeNet Health.
- COMPLETED
- Registry status
- NA
- Development phase
- 202 participants
- Enrollment target
- 12
- Study locations
Study Summary
The study will compare treatment with DermACELL to conventional care in diabetic foot ulcers (DFU) and venous stasis ulcers (VSU).
Primary Outcome
The primary outcome is the comparison of the proportion of chronic wounds treated with DermACELL and treated with conventional care that have achieved 100% re-epithelialization without dressing or drainage requirements at 12 weeks. Wound closure is defined as first observation of 100% re-epithelialization without drainage or dressing requirements and complete wound closure is defined as 100% re-epithelialization without dressing or drainage requirements confirmed at two consecutive study visits
Conditions Studied
Interventions
- OTHER DermACELL
- OTHER GraftJacket
- OTHER Conventional Care Dressings
Study Locations (12)
California
- ILD Research Center - Carlsbad
- Center for Clinical Research - Castro Valley
- Limb Preservation Platform - Fresno
- Limb Preservation Platform - Fresno
Pennsylvania
- Wound Institute and Reseach Center - Dunmore
- VA Pittsburgh Healthcare System - Pittsburgh
Alabama
- Institute for Advanced Wound Care - Montgomery
Arizona
- Southern Arizona VA Health Care System - Tucson
Connecticut
- Fairfield County Foot Surgeons - Norwalk
Florida
- Andrews Research and Education Institute - Gulf Breeze
Illinois
- Rosalind Franklin University, CLEAR - North Chicago
Massachusetts
- Boston Medical College - Boston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 202 participants |
| Start Date | 2013-10 |
| Est. Completion | 2016-04 |
| Phase | NA |
What the finished NCT01970163 record still lists
NCT01970163 is an interventional study that assigns participants to a tested intervention. The registered 202 participants enrollment target is mid-sized for trials with a published cap, below the 252-participant average among 67 other Diabetic Foot Ulcer trials with a reported enrollment target (20% lower).
The record links to 1 condition, with Diabetic Foot Ulcer appearing as the primary indexed condition, and to 3 interventions - of which DermACELL is the first listed.
NCT01970163 lists 12 locations in 8 states (California, Pennsylvania, Alabama).
Frequently Asked Questions
What is clinical trial NCT01970163 about?
NCT01970163 is a clinical study titled "DermACELL in Subjects With Chronic Wounds of the Lower Extremities". The study will compare treatment with DermACELL to conventional care in diabetic foot ulcers (DFU) and venous stasis ulcers (VSU).
What is the current status of trial NCT01970163?
This trial is currently completed. It is a NA study. The enrollment target is 202 participants. The study started on 2013-10. Estimated completion is 2016-04.
What conditions does trial NCT01970163 study?
This clinical trial studies the following conditions: Diabetic Foot Ulcer.
What interventions are being tested in trial NCT01970163?
The interventions under investigation include: DermACELL (OTHER), GraftJacket (OTHER), Conventional Care Dressings (OTHER).
Who is sponsoring clinical trial NCT01970163?
This trial is sponsored by LifeNet Health, which has 8 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01970163 being conducted?
This trial has 12 study locations across Alabama, Arizona, California, Connecticut, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Diabetic Foot 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 NCT01970163's enrollment target sits among peer trials
202 18th of 67 higher than 50 of 67 other Diabetic Foot Ulcer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Diabetic Foot 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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