Dehydrated Human Umbilical Cord Allograft in the Management of Diabetic Foot Ulcers

Completed · Not applicable

Conditions studied: Diabetic Foot Ulcers

In brief

A Multicenter, Prospective, Randomized Controlled Comparative Parallel Study To determine the safety and effectiveness of EpiCord as compared to standard of care (SOC) therapy for the treatment of chronic, non-healing diabetic foot ulcers (DFUs)

Key facts

Study ID: NCT02844660
Run by: MiMedx Group, Inc.
People needed: 130
Starts: 2016-07-01
Expected to finish: 2018-07-01
Last updated by the study team: 2022-05-13

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Subject has a known history of Type 1 or Type 2 diabetes (criteria for the diagnosis of diabetes mellitus per ADA).
Index ulcer characteristics:
a. Ulcer present for ≥ 30 days prior to randomization (Day 0) b. Index ulcer is located below the ankle c. Index ulcer area after debridement is ≥ 1 cm² and ≤ 15 cm² at the randomization visit 3. Subject has completed 14-day run-in period with ≤ 30% wound area reduction post-debridement.
Subject has adequate circulation to the affected extremity, as demonstrated by one of the following within the past 60 days:
Dorsum transcutaneous oxygen test (TcPO2) with results ≥ 30 mmHg, OR
ABIs with results of ≥ 0.7 and ≤ 1.2, OR
Doppler arterial waveforms, which are triphasic or biphasic at the ankle of the affected foot 5. Age ≥ 18 6. The subject is willing and able to provide informed consent and participate in all procedures and follow-up evaluations necessary to complete the study
Index Ulcer Assessment:
Penetrates down totendon, or bone
Presence of another diabetic foot ulcer within 3 cm of the index ulcer
Index ulcer determined to be due to active Charcot deformity or major structural abnormalities of the foot
Exhibits clinical signs and symptoms of infection
Known or suspected local skin malignancy to the index diabetic ulcer
Wound duration > one year without intermittent closure
Prior therapies - Subjects receiving treatment with any of the following will not be eligible for enrollment:
In the last 7 days - Negative pressure wound therapy (wound vac or SNaP®) of the index ulcer
In the last 7 days - Hyperbaric oxygen (HBO) therapy
In the last 10 days - Chemical debridement, Dakin's solution, medical honey therapy
In the last 30 days - Treatment with cytotoxic chemotherapy, application of topical steroids to the ulcer surface, or use of ≥ 14 days of immune-suppressants (including systemic corticosteroids); or, subject is anticipated to require such medications during the course of the study
In the last 30 days - study ulcer treatment with any biological skin substitutes, including EpiCord, biomedical or topical growth factors, tissue engineered materials (e.g. Apligraf® or Dermagraft®), or other scaffold materials (e.g. OASIS® Wound Matrix, MatriStem® Wound Matrix, Grafix, etc.)
In the last 30 days - Subject has been on any investigational drug(s) or therapeutic device(s)
In the last 6 months - Amputation or revascularization (surgical or stenting) to the affected leg or foot
Subject criteria that will make subject ineligible for enrollment:
Known osteomyelitis or active cellulitis at wound site
Hemoglobin A1C >12 in the last 60 days prior to randomization

Where it is running

Central Research Associates — Birmingham, Alabama, United States
Arizona Regional Medical Research (ARMR) — Tucson, Arizona, United States
ILD Research — Carlsbad, California, United States
Limb Preservation Platform, Inc — Fresno, California, United States
Foot and ankle clinic — Los Angeles, California, United States
Doctors Research Network — Miami, Florida, United States
Joseph M. Still Burn Center at Doctors Hospital — Augusta, Georgia, United States
Ochsner Clinic Foundation — New Orleans, Louisiana, United States
Advanced Foot & Ankle Center — Las Vegas, Nevada, United States
Foot and Ankle Center — Haverford, Pennsylvania, United States
Futuro Clinical Trials — McAllen, Texas, United States
Ambulatory Foot & Ankle Center, PC — Hampton, Virginia, United States
Costal Podiatry — Virginia Beach, Virginia, United States

Full record on ClinicalTrials.gov

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