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NCT00587223 · ClinicalTrials.gov registry record · Phase 3

Safety and Efficacy of Apligraf in Nonhealing Wounds of Subjects With Junctional or Dystrophic Epidermolysis Bullosa (EB)

A Phase 3 study, sponsored by Organogenesis.

Terminated
Registry status
Phase 3
Development phase
1
Enrollment target

NCT00587223: Clinical Trial Phase 3 study, sponsored by Organogenesis.

NCT00587223 is a Phase 3 study that was terminated before completion, run by Organogenesis. The registered enrollment target is 1 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (100% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00587223, a Phase 3 study, was terminated before completion, sponsored by Organogenesis.

TERMINATED
Registry status
Phase 3
Development phase
1 participants
Enrollment target

Study Summary

The purpose of this study is to evaluate the use of Apligraf for the treatment of nonhealing wounds in subjects with dystrophic or junctional epidermolysis bullosa. Apligraf will be evaluated for efficacy and safety compared to a conventional nonadherent dressing. A matched-pair design will be used to evaluate Apligraf treatment versus conventional treatment in 68 study pairs.

Interventions

  • DEVICE Apligraf
  • OTHER Standard dressing regimen

Trial Details

FieldValue
Enrollment Target 1 participants
Start Date 2007-12
Est. Completion 2008-12
Phase Phase 3
Organogenesis

20 total trials

Why NCT00587223 stopped before completion

NCT00587223 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 1 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (100% lower).

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

NCT00587223 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00587223 about?

NCT00587223 is a clinical study titled "Safety and Efficacy of Apligraf in Nonhealing Wounds of Subjects With Junctional or Dystrophic Epidermolysis Bullosa (EB)". The purpose of this study is to evaluate the use of Apligraf for the treatment of nonhealing wounds in subjects with dystrophic or junctional epidermolysis bullosa. Apligraf will be evaluated for efficacy and safety compared to a conventional nonadherent dressing. A matched-pair design will be used ...

What is the current status of trial NCT00587223?

This trial is currently terminated. It is a Phase 3 study. The enrollment target is 1 participants. The study started on 2007-12. Estimated completion is 2008-12.

What interventions are being tested in trial NCT00587223?

The interventions under investigation include: Apligraf (DEVICE), Standard dressing regimen (OTHER).

Who is sponsoring clinical trial NCT00587223?

This trial is sponsored by Organogenesis, which has 20 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT00587223's enrollment target sits among peer trials

1 2001st of 2000 the lowest 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 NCT00587223, the US trial registry maintained by the National Library of Medicine. NCT00587223 (small enrollment · none site footprint · terminated) retrieved and formatted by PlainTrial, see methodology.