Trial of Dehydrated Human Amnion/Chorion Membrane (dHACM) In the Management of Diabetic Foot Ulcers

A Multicenter, Prospective, Randomized, Controlled, Comparative Parallel Study of Dehydrated Human Amnion/Chorion Membrane (dHACM) Wound Graft in the Management of Diabetic Foot Ulcers

The objective of this study is to evaluate the percentage of patients with complete diabetic foot ulcer (DFU) closure following up to 12 weeks of treatment with either dehydrated human amnion/chorion membrane (dHACM) plus standard of care (SOC) or SOC alone.

Study Overview

• Status: Completed
• Conditions: Diabetic Foot Ulcer
• Intervention / Treatment: Other: Standard of Care: Moist Wound Therapy and Offloading; Other: EpiFix plus Standard of Care

• Study Type: Interventional
• Enrollment (Actual): 132
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Birmingham, Alabama, United States, 35205
      • Central Research Associates, Inc.
  • California
    • Bakersfield, California, United States, 93309
      • Stockdale Podiatry Group
    • Castro Valley, California, United States, 94546
      • Center for Clinical Research Inc
    • Fresno, California, United States, 93721
      • Limb Preservation Platform
    • Fresno, California, United States, 93720
      • Valley Vascular Surgery Associates
    • Indio, California, United States, 92201
      • Novak Urgent Care and Family Practice
    • Loma Linda, California, United States, 92357
      • Loma Linda VA Medical Center
    • Los Angeles, California, United States, 90057
      • Foot & Ankle Clinic
    • Palm Springs, California, United States, 92262
      • Palmtree Clinical Research, Inc.
    • Sacramento, California, United States, 95628
      • Center for Clinical Research, Inc.
    • San Francisco, California, United States, 94115
      • Center for Clinical Research
  • Massachusetts
    • Framingham, Massachusetts, United States, 01702
      • MetroWest Medical Center
    • Weymouth, Massachusetts, United States, 02190
      • South Shore Hospital
  • Ohio
    • Toledo, Ohio, United States, 43606
      • Jobst Vascular Institute, Promedica Toledo Hospital
  • Oregon
    • Eugene, Oregon, United States, 97401
      • Center for Clinical Research, Inc.
  • South Carolina
    • Columbia, South Carolina, United States, 29209
      • Dorn VA
  • Texas
    • McAllen, Texas, United States, 78501
      • Futuro Clinical Trials, LLC
  • Utah
    • Murray, Utah, United States, 84157
      • IMC Wound Care
    • Salt Lake City, Utah, United States, 84143
      • LDS Hospital
  • Virginia
    • Virginia Beach, Virginia, United States, 23464
      • Coastal Podiatry, Inc.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Male or female age 18 or older.
2. The patient is willing and able to provide informed consent and participate in all procedures and follow up evaluations necessary to complete the study.
3. Patient's ulcer must be diabetic in origin with a size ranging from 1 to 25 cm2. Debridement will be done prior to randomization, if clinically indicated.
4. Wounds should be diabetic foot ulcers located on the dorsal or plantar surface of the foot.
5. Patients with Type 1 or 2 diabetes (criteria for the diagnosis of diabetes mellitus per ADA).
6. Ulcer must be present for a minimum of 30 days before enrollment/randomization, with documented failure of prior treatment to heal the wound (≤25% wound area reduction after 14 consecutive days of therapy immediately prior to randomization when treated with standard protocol of care).
7. Affected leg has been offloaded (removable walker or total contact cast) for >14 consecutive days prior to randomization.
8. Serum Creatinine less than 3.0mg/dl (within last 6 months).
9. HbA1c less than 12% within previous 60 days.

10. Patient 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 ≥30mmHg, OR
    • ABIs with results of ≥0.7 and ≤1.2, OR
    • Doppler arterial waveforms, which are triphasic or biphasic at the ankle of affected foot.
11. Females of childbearing potential must be willing to use acceptable methods of contraception (birth control pills, barriers, or abstinence).

Exclusion Criteria:

1. Patients presenting with an ulcer probing to bone (UT Grade IIIA-D). A positive probe-tobone will be confirmed when bone or joint can be felt with a sterile, ophthalmological probe.
2. Patients with multiple wounds on the same foot where other wounds are within 3 cm of the wound under care.
3. Patients considered not in reasonable metabolic control, confirmed by an HbA1c 12% or greater at any time within previous 60 days.
4. Known history of poor compliance with medical treatments.
5. Patients currently enrolled in this study. Concurrent enrollment in the study is prohibited.
6. Patients treated with investigational drug(s) or therapeutic device(s) within 30 days.
7. Patients currently receiving radiation therapy or chemotherapy.
8. Known or suspected local skin malignancy to the index diabetic ulcer.
9. Patients diagnosed with autoimmune connective tissue diseases.
10. Non-revascularizable surgical sites.
11. Active infection at index site or currently being treated with antibiotics
12. Any pathology that would limit the blood supply and compromise healing.
13. Patients that have received a biomedical or topical growth factor for their wound within the previous 30 days. Study ulcer has been previously treated with tissue engineered materials (e.g. Apligraf® or Dermagraft®) or other scaffold materials (e.g. Oasis, Matristem) within the last 30 days.
14. Patients who are known to be pregnant, plan to become pregnant, or are breast feeding.
15. Known allergy to Gentamicin sulfate or Streptomycin sulfate.
16. Active Charcot deformity or major structural abnormalities of the foot.
17. Wounds that are greater than one year in duration without intermittent closure.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Control; Standard of Care: Moist Wound Therapy and Offloading	Other: Standard of Care: Moist Wound Therapy and Offloading; Standard of Care: Moist Wound Therapy and Offloading
Experimental: EpiFix plus Standard of Care; Weekly application of EpiFix (up to 12 week) and standard of care (moist wound therapy and offloading)	Other: EpiFix plus Standard of Care; Weekly application of EpiFix and Standard of Care

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of subjects with complete closure of the study ulcer	Assessed by the Investigator, during treatment (Visits 1 - 13).	Week 12

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to complete closure for both groups	As assessed by photographic evaluation and the Investigator	Up to 12 Weeks
Rate of wound closure	As assessed by photographic evaluation and the Investigator	Up to Week 12
Incidence of ulcer recurrence	Incidence of ulcer recurrence at the site of the study ulcer during the follow up phase.	Up to Week 16
Quality of Life	Change in quality of life metrics as measured by SF-36 Health Survey and changes in the patient's reported pain scores as measured by the Visual Analog Scale.	Up to Week 12
Cost effectiveness of treatment	Cost effectiveness of treatment regimen.	Up to Week 12

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety	The Safety population will be used for the analysis of safety endpoints.	Up to Week 16

Collaborators and Investigators

• Sponsor: MiMedx Group, Inc.
• Investigators: Principal Investigator: William Tettelbach, MD, Intermountain Medical Center

Study record dates

Study Major Dates

• Study Start: July 1, 2012
• Primary Completion (Actual): June 1, 2018
• Study Completion (Actual): June 1, 2018

Study Registration Dates

• First Submitted: September 19, 2012
• First Submitted That Met QC Criteria: September 21, 2012
• First Posted (Estimate): September 26, 2012

Study Record Updates

• Last Update Posted (Actual): September 24, 2018
• Last Update Submitted That Met QC Criteria: September 21, 2018
• Last Verified: September 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Skin Diseases; Endocrine System Diseases; Diabetic Angiopathies; Leg Ulcer; Skin Ulcer; Diabetes Complications; Diabetes Mellitus; Diabetic Neuropathies; Foot Diseases; Diabetic Foot; Foot Ulcer; Ulcer
• Other Study ID Numbers: EFDFU003