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NCT03881267 · ClinicalTrials.gov registry record · NA

SkinTE® in the Treatment of Venous Leg Wounds

A NA study, sponsored by PolarityTE.

Completed
Registry status
NA
Development phase
29
Enrollment target

NCT03881267: Completed NA study, sponsored by PolarityTE.

NCT03881267 is a NA study that has completed, run by PolarityTE. The registered enrollment target is 29 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (98% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT03881267, a NA study, has completed, sponsored by PolarityTE.

COMPLETED
Registry status
NA
Development phase
29 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 Venous Leg Wounds

Primary Outcome

examine percent of ulcers healed at week twelve

Interventions

  • OTHER Additional Outer Dressing Application
  • OTHER Fibracol Wound Dressing
  • OTHER Human Autologous Homologous Skin Construct

Trial Details

FieldValue
Enrollment Target 29 participants
Start Date 2019-03-29
Est. Completion 2021-03-23
Phase NA
PolarityTE

4 total trials

What the finished NCT03881267 record still lists

NCT03881267 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 29 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (98% lower).

The record links to 0 conditions, and to 3 interventions - of which Additional Outer Dressing Application is the first listed.

NCT03881267 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT03881267 about?

NCT03881267 is a clinical study titled "SkinTE® in the Treatment of Venous Leg 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 Venous Leg Wounds

What is the current status of trial NCT03881267?

This trial is currently completed. It is a NA study. The enrollment target is 29 participants. The study started on 2019-03-29. Estimated completion is 2021-03-23.

What interventions are being tested in trial NCT03881267?

The interventions under investigation include: Additional Outer Dressing Application (OTHER), Fibracol Wound Dressing (OTHER), Human Autologous Homologous Skin Construct (OTHER).

Who is sponsoring clinical trial NCT03881267?

This trial is sponsored by PolarityTE, which has 4 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT03881267's enrollment target sits among peer trials

29 1702nd of 2000 higher than 297 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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Source: ClinicalTrials.gov NCT03881267, the US trial registry maintained by the National Library of Medicine. NCT03881267 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.