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NCT01450943 · ClinicalTrials.gov registry record · Phase 3

VA MERIT: A Comparative Efficacy Study: Treatment of Non-Healing Diabetic

A Phase 3 study of Diabetic Foot Ulcer, sponsored by VA Office of Research and Development.

Completed
Registry status
Phase 3
Development phase
120
Enrollment target
1
Study location

NCT01450943: Completed Phase 3 study of Diabetic Foot Ulcer, sponsored by VA Office of Research and Development.

NCT01450943 is a Phase 3 study of Diabetic Foot Ulcer that has completed, run by VA Office of Research and Development. The registered enrollment target is 120 participants, below the 253-participant average among 67 other Diabetic Foot Ulcer trials with a reported enrollment target (53% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.

View on ClinicalTrials.gov ↗

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The verdict

NCT01450943, a Phase 3 study of Diabetic Foot Ulcer, has completed, sponsored by VA Office of Research and Development.

COMPLETED
Registry status
Phase 3
Development phase
120 participants
Enrollment target
1
Study location

Study Summary

The primary objective of this study is to assess the effectiveness of cellular dermal replacement tissue vs. non-viable extracellular matrix (ECM) for the treatment of non-healing diabetic foot ulcers. Our hypothesis is that these devices are of equal efficacy.

Primary Outcome

The primary outcome of interest is defined as the wound healed completely on or before visit 15, regardless of a later recurrence.

Conditions Studied

Interventions

  • DEVICE SECONDARY dressing gauze and tape
  • PROCEDURE debridement, irrigation
  • DEVICE Dermagraft
  • DEVICE Oasis

Study Locations (1)

California

  • VA Northern California Health Care System, Mather, CA - Sacramento

Trial Details

FieldValue
Enrollment Target 120 participants
Start Date 2011-10-01
Est. Completion 2018-04-04
Phase Phase 3
VA Office of Research and Development

1,668 total trials

What the finished NCT01450943 record still lists

NCT01450943 is an interventional study that assigns participants to a tested intervention. The registered 120 participants enrollment target is mid-sized for trials with a published cap, below the 253-participant average among 67 other Diabetic Foot Ulcer trials with a reported enrollment target (53% lower).

The record links to 1 condition, with Diabetic Foot Ulcer appearing as the primary indexed condition, and to 4 interventions - of which SECONDARY dressing gauze and tape is the first listed.

NCT01450943 reports a single indexed study location in California.

Frequently Asked Questions

What is clinical trial NCT01450943 about?

NCT01450943 is a clinical study titled "VA MERIT: A Comparative Efficacy Study: Treatment of Non-Healing Diabetic". The primary objective of this study is to assess the effectiveness of cellular dermal replacement tissue vs. non-viable extracellular matrix (ECM) for the treatment of non-healing diabetic foot ulcers. Our hypothesis is that these devices are of equal efficacy.

What is the current status of trial NCT01450943?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 120 participants. The study started on 2011-10-01. Estimated completion is 2018-04-04.

What conditions does trial NCT01450943 study?

This clinical trial studies the following conditions: Diabetic Foot Ulcer.

What interventions are being tested in trial NCT01450943?

The interventions under investigation include: SECONDARY dressing gauze and tape (DEVICE), debridement, irrigation (PROCEDURE), Dermagraft (DEVICE), Oasis (DEVICE).

Who is sponsoring clinical trial NCT01450943?

This trial is sponsored by VA Office of Research and Development, which has 1,668 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT01450943 being conducted?

This trial has 1 study location across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Similar trials for Diabetic Foot Ulcer

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT01450943's enrollment target sits among peer trials

120 32nd of 67 higher than 34 of 67 other Diabetic Foot Ulcer trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Diabetic Foot Ulcer 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 NCT01450943, the US trial registry maintained by the National Library of Medicine. NCT01450943 (mid enrollment · single site footprint · completed) retrieved and formatted by PlainTrial, see methodology.