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NCT03881254 · ClinicalTrials.gov registry record · NA
SkinTE™ in the Treatment of Diabetic Foot Wounds
A NA study, sponsored by PolarityTE.
- Completed
- Registry status
- NA
- Development phase
- 100
- Enrollment target
NCT03881254: Completed NA study, sponsored by PolarityTE.
NCT03881254 is a NA study that has completed, run by PolarityTE. The registered enrollment target is 100 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (93% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03881254, a NA study, has completed, sponsored by PolarityTE.
- COMPLETED
- Registry status
- NA
- Development phase
- 100 participants
- Enrollment target
Study Summary
This study is a prospective, multi-center, randomized controlled trial designed to collect patient outcome data on a commercially available human autologous homologous skin construct with SOC dressing compared to SOC dressings alone in the treatment of Diabetic Foot Wounds.
Primary Outcome
examine percent of ulcers healed at week twelve
Interventions
- OTHER Offloading
- OTHER Fibracol Wound Dressing
- OTHER Human Autologous Homologous Skin Construct
- OTHER Additional Outer Dressing Applicaiton
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 100 participants |
| Start Date | 2019-04-02 |
| Est. Completion | 2021-07-28 |
| Phase | NA |
What the finished NCT03881254 record still lists
NCT03881254 is an interventional study that assigns participants to a tested intervention. The registered 100 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (93% lower).
The record links to 0 conditions, and to 4 interventions - of which Offloading is the first listed.
NCT03881254 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03881254 about?
NCT03881254 is a clinical study titled "SkinTE™ in the Treatment of Diabetic Foot Wounds". This study is a prospective, multi-center, randomized controlled trial designed to collect patient outcome data on a commercially available human autologous homologous skin construct with SOC dressing compared to SOC dressings alone in the treatment of Diabetic Foot Wounds.
What is the current status of trial NCT03881254?
This trial is currently completed. It is a NA study. The enrollment target is 100 participants. The study started on 2019-04-02. Estimated completion is 2021-07-28.
What interventions are being tested in trial NCT03881254?
The interventions under investigation include: Offloading (OTHER), Fibracol Wound Dressing (OTHER), Human Autologous Homologous Skin Construct (OTHER), Additional Outer Dressing Applicaiton (OTHER).
Who is sponsoring clinical trial NCT03881254?
This trial is sponsored by PolarityTE, which has 4 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03881254's enrollment target sits among peer trials
100 840th of 2000 higher than 1,081 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA 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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