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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT01693133
Recruitment Status : Recruiting
First Posted : September 26, 2012
Last Update Posted : February 23, 2017
Information provided by (Responsible Party):
MiMedx Group, Inc.

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Diabetic Foot Ulcer Other: Standard of Care: Moist Wound Therapy and Offloading Other: EpiFix plus Standard of Care Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 130 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Multicenter, Prospective, Randomized, Controlled, Comparative Parallel Study of Dehydrated Human Amnion/Chorion Membrane (dHACM) Wound Graft in the Management of Diabetic Foot Ulcers
Study Start Date : July 2012
Estimated Primary Completion Date : May 2017
Estimated Study Completion Date : October 2017

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. Percentage of subjects with complete closure of the study ulcer [ Time Frame: Week 12 ]
    Assessed by the Investigator, during treatment (Visits 1 - 13).

Secondary Outcome Measures :
  1. Time to complete closure for both groups [ Time Frame: Up to 12 Weeks ]
    As assessed by photographic evaluation and the Investigator

  2. Rate of wound closure [ Time Frame: Up to Week 12 ]
    As assessed by photographic evaluation and the Investigator

  3. Incidence of ulcer recurrence [ Time Frame: Up to Week 16 ]
    Incidence of ulcer recurrence at the site of the study ulcer during the follow up phase.

  4. Quality of Life [ Time Frame: Up to Week 12 ]
    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.

  5. Cost effectiveness of treatment [ Time Frame: Up to Week 12 ]
    Cost effectiveness of treatment regimen.

Other Outcome Measures:
  1. Safety [ Time Frame: Up to Week 16 ]
    The Safety population will be used for the analysis of safety endpoints.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01693133

Contact: William Tettlebach, MD 801-507-9310

United States, Alabama
Central Research Associates, Inc. Active, not recruiting
Birmingham, Alabama, United States, 35205
United States, California
Stockdale Podiatry Group Completed
Bakersfield, California, United States, 93309
Center for Clinical Research Inc Recruiting
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Novak Urgent Care and Family Practice Completed
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Loma Linda VA Medical Center Completed
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Foot & Ankle Clinic Active, not recruiting
Los Angeles, California, United States, 90057
Palmtree Clinical Research, Inc. Completed
Palm Springs, California, United States, 92262
Center for Clinical Research, Inc. Active, not recruiting
Sacramento, California, United States, 95628
Center for Clinical Research Active, not recruiting
San Francisco, California, United States, 94115
United States, Massachusetts
MetroWest Medical Center Completed
Framingham, Massachusetts, United States, 01702
South Shore Hospital Completed
Weymouth, Massachusetts, United States, 02190
United States, Ohio
Jobst Vascular Institute, Promedica Toledo Hospital Active, not recruiting
Toledo, Ohio, United States, 43606
United States, Oregon
Center for Clinical Research, Inc. Completed
Eugene, Oregon, United States, 97401
United States, South Carolina
Dorn VA Completed
Columbia, South Carolina, United States, 29209
United States, Texas
Futuro Clinical Trials, LLC Recruiting
McAllen, Texas, United States, 78501
Contact: Jessica Rodriguez    956-999-8399    RODRIGUEZCFFC@GMAIL.COM   
Principal Investigator: Joseph M Caporusso, DPM         
United States, Utah
IMC Wound Care Completed
Murray, Utah, United States, 84157
LDS Hospital Completed
Salt Lake City, Utah, United States, 84143
United States, Virginia
Coastal Podiatry, Inc. Active, not recruiting
Virginia Beach, Virginia, United States, 23464
Sponsors and Collaborators
MiMedx Group, Inc.
Principal Investigator: William Tettelbach, MD Intermountain Medical Center

Responsible Party: MiMedx Group, Inc. Identifier: NCT01693133     History of Changes
Other Study ID Numbers: EFDFU003
First Posted: September 26, 2012    Key Record Dates
Last Update Posted: February 23, 2017
Last Verified: February 2017

Additional relevant MeSH terms:
Diabetic Foot
Foot Ulcer
Pathologic Processes
Diabetic Angiopathies
Vascular Diseases
Cardiovascular Diseases
Leg Ulcer
Skin Ulcer
Skin Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Diabetic Neuropathies
Foot Diseases