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

NCT01450943 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2019-09-17

Study results available
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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.

Conditions

  • Diabetic Foot Ulcer

Interventions

DEVICE

SECONDARY dressing gauze and tape

SECONDARY dressing gauze and tape

PROCEDURE

debridement, irrigation

debridement, irrigation

DEVICE

Dermagraft

Dermagraft per company protocol

DEVICE

Oasis

Oasis per company protocol

Sponsors & Collaborators

  • VA Northern California Health Care System

    collaborator FED

  • VA Office of Research and Development

    lead FED

Principal Investigators

  • Rivkah R. Isseroff, MD · VA Northern California Health Care System, Mather, CA

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-10-01
Primary Completion
2017-12-14
Completion
2018-04-04
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01450943 on ClinicalTrials.gov