A Comparative Efficacy Study: Treatment for Non-healing Diabetic Foot Ulcers

March 19, 2021 updated by: Integra LifeSciences Corporation

An Evaluation of Tissue Engineering Approaches for Treatment of Neuropathic Diabetic Foot Ulcers Resistant to Standard of Care: A Prospective, Randomized Controlled Trial

The primary objective of this study is to assess the effectiveness of MatriStem devices compared to cellular dermal replacement tissue, for the treatment of non-healing diabetic foot ulcers.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

Due to their characteristically poor healing capacity, diabetic foot ulcers (DFUs) are challenging for clinicians to treat. This prospective, multi-center clinical study will examine outcomes following treatment of DFUs, with one of two FDA cleared tissue-engineered devices, MatriStem® or cellular dermal replacement tissue, on DFUs that have demonstrated an inadequate response to initial standard of care therapy. The incidence of ulcer closure, rate of wound closure, and quality of life will be evaluated over a eight week period.

Study Type

Interventional

Enrollment (Actual)

56

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85012
        • Carl t. Hayden Phoenix VA Medical Center
      • Phoenix, Arizona, United States, 85015
        • Associated Foot & Ankle Specialists, PC
    • California
      • Castro Valley, California, United States, 94546
        • Center for Clinical Research Inc.
      • Fresno, California, United States, 93720
        • Valley Vascular Surgery Associates
    • Colorado
      • Denver, Colorado, United States, 80220
        • Denver VA Medical Center
    • District of Columbia
      • Washington, District of Columbia, United States, 20007
        • Georgetown University Medical Center
    • Florida
      • Homestead, Florida, United States, 33030
        • Advanced Research Institute of Miami
      • Miami Beach, Florida, United States, 33140
        • NewPhase Clinical Trials, Corp.
      • Saint Petersburg, Florida, United States, 33713
        • Professional Health Care of Pinellas

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 85 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Major Inclusion Criteria:

  • Subject has a current diagnosis of type I or type II diabetes
  • Subject's ulcer is on the forefoot or heel
  • Subject has chronic ulcer - has been present for minimum of 4 weeks
  • Subject's ulcer extends through the dermis and into the subcutaneous tissue
  • Subject's HgbA1c <12%
  • Subject has adequate circulation to the study foot as evidenced by a Doppler measured ABI greater than or equal to 0.7after 10 minutes rest

Major Exclusion Criteria:

  • Subject has a known sensitivity to bovine- or porcine-derived products.
  • Subject's ulcer is due to a non-diabetic etiology
  • Subject's ulcer is over a Charcot deformity of the mid-foot
  • Subject's random blood sugar readings are >450 mg/dL
  • Subject is on dialysis
  • Subject has a non-study ulcer on the study limb located within 7.0 cm of the study ulcer

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Experimental
MatriStem MicroMatrix and MatriStem Wound Matrix
Device: MatriStem
MatriStem MicroMatrix and MatriStem Wound Matrix
ACTIVE_COMPARATOR: Comparator
Cellular Dermal Replacement Tissue
Device: Cellular Dermal Replacement Tissue
Cellular Dermal Replacement Tissue

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants With Complete Wound Closure
Time Frame: 8 Weeks
Number of participants with incidence of complete wound closure
8 Weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Integra LifeSciences Corporation

Investigators

  • Study Director: Thomas Gilbert, PhD, Integra LifeSciences

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2013

Primary Completion (ACTUAL)

December 1, 2015

Study Completion (ACTUAL)

December 1, 2015

Study Registration Dates

First Submitted

May 17, 2013

First Submitted That Met QC Criteria

May 17, 2013

First Posted (ESTIMATE)

May 21, 2013

Study Record Updates

Last Update Posted (ACTUAL)

April 15, 2021

Last Update Submitted That Met QC Criteria

March 19, 2021

Last Verified

March 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ACL2011-002-I

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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