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NCT01270633 · ClinicalTrials.gov registry record · NA

A Study With Primatrix Dermal Repair Scaffold For The Treatment Of Diabetic Foot Ulcers

A NA study, sponsored by Integra LifeSciences Corporation.

Terminated
Registry status
NA
Development phase
30
Enrollment target

NCT01270633: Clinical Trial NA study, sponsored by Integra LifeSciences Corporation.

NCT01270633 is a NA study that was terminated before completion, run by Integra LifeSciences Corporation. The registered enrollment target is 30 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

NCT01270633, a NA study, was terminated before completion, sponsored by Integra LifeSciences Corporation.

TERMINATED
Registry status
NA
Development phase
30 participants
Enrollment target

Study Summary

The purpose of this study is to compare the clinical and economic effectiveness of PriMatrix and Standard of Care in the treatment of diabetic foot ulcers (DFUs) in subjects with controlled diabetes mellitus and without significantly compromised arterial circulation.

Primary Outcome

Percent of study ulcers healed at week 12 post-randomization

Interventions

  • OTHER Standard of Care
  • DEVICE PriMatrix

Trial Details

FieldValue
Enrollment Target 30 participants
Start Date 2010-12
Est. Completion 2017-09
Phase NA
Integra LifeSciences Corporation

60 total trials

Why NCT01270633 stopped before completion

NCT01270633 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 30 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 2 interventions - of which Standard of Care is the first listed.

NCT01270633 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT01270633 about?

NCT01270633 is a clinical study titled "A Study With Primatrix Dermal Repair Scaffold For The Treatment Of Diabetic Foot Ulcers". The purpose of this study is to compare the clinical and economic effectiveness of PriMatrix and Standard of Care in the treatment of diabetic foot ulcers (DFUs) in subjects with controlled diabetes mellitus and without significantly compromised arterial circulation.

What is the current status of trial NCT01270633?

This trial is currently terminated. It is a NA study. The enrollment target is 30 participants. The study started on 2010-12. Estimated completion is 2017-09.

What interventions are being tested in trial NCT01270633?

The interventions under investigation include: Standard of Care (OTHER), PriMatrix (DEVICE).

Who is sponsoring clinical trial NCT01270633?

This trial is sponsored by Integra LifeSciences Corporation, which has 60 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT01270633's enrollment target sits among peer trials

30 1593rd of 2000 higher than 299 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 NCT01270633, the US trial registry maintained by the National Library of Medicine. NCT01270633 (small enrollment · none site footprint · terminated) retrieved and formatted by PlainTrial, see methodology.