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NCT05372809 · ClinicalTrials.gov registry record · Phase 3

Multi-Center, Prospective, Randomized Controlled Trial Evaluating SkinTE® in the Treatment of Wagner 2 DFUs

A Phase 3 study, sponsored by PolarityTE.

Terminated
Registry status
Phase 3
Development phase
42
Enrollment target

NCT05372809: Clinical Trial Phase 3 study, sponsored by PolarityTE.

NCT05372809 is a Phase 3 study that was terminated before completion, run by PolarityTE. The registered enrollment target is 42 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (95% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT05372809, a Phase 3 study, was terminated before completion, sponsored by PolarityTE.

TERMINATED
Registry status
Phase 3
Development phase
42 participants
Enrollment target

Study Summary

The purpose of this study is to assess the safety and efficacy of SkinTE for treatment of Wagner grade 2 diabetic foot ulcers.

Primary Outcome

Wound closure is confirmed at two consecutive visits each two weeks apart

Interventions

  • OTHER Control
  • BIOLOGICAL SkinTE

Trial Details

FieldValue
Enrollment Target 42 participants
Start Date 2022-04-28
Est. Completion 2024-02-21
Phase Phase 3
PolarityTE

4 total trials

Why NCT05372809 stopped before completion

NCT05372809 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 42 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (95% lower).

The record links to 0 conditions, and to 2 interventions - of which Control is the first listed.

NCT05372809 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT05372809 about?

NCT05372809 is a clinical study titled "Multi-Center, Prospective, Randomized Controlled Trial Evaluating SkinTE® in the Treatment of Wagner 2 DFUs". The purpose of this study is to assess the safety and efficacy of SkinTE for treatment of Wagner grade 2 diabetic foot ulcers.

What is the current status of trial NCT05372809?

This trial is currently terminated. It is a Phase 3 study. The enrollment target is 42 participants. The study started on 2022-04-28. Estimated completion is 2024-02-21.

What interventions are being tested in trial NCT05372809?

The interventions under investigation include: Control (OTHER), SkinTE (BIOLOGICAL).

Who is sponsoring clinical trial NCT05372809?

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

How this trial's enrollment target compares

Where NCT05372809's enrollment target sits among peer trials

42 1877th of 2000 higher than 124 of 2,000 other Phase 3 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 3 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 NCT05372809, the US trial registry maintained by the National Library of Medicine. NCT05372809 (small enrollment · none site footprint · terminated) retrieved and formatted by PlainTrial, see methodology.