Use of dHACM in the Treatment of Venous Leg 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. Read our disclaimer for details. Identifier: NCT02011503
Recruitment Status : Active, not recruiting
First Posted : December 13, 2013
Last Update Posted : March 23, 2017
Information provided by (Responsible Party):
MiMedx Group, Inc.

Brief Summary:
The overall objective of this study is to evaluate the effectiveness of dehydrated human amnion/ chorion membrane (dHACM) in reducing time to complete wound closure in patients with venous leg ulcers (VLUs).

Condition or disease Intervention/treatment Phase
Leg Ulcer Procedure: Multi-layer compression therapy Other: Application of dHACM Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomized Controlled Clinical Trial Evaluating The Application Of Dehydrated Human Amnion/ Chorion Membrane (dHACM) Plus Standard Of Care Vs. Standard Of Care Alone In The Treatment Of Venous Leg Ulcers
Study Start Date : March 2014
Estimated Primary Completion Date : June 2017
Estimated Study Completion Date : July 2017

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: dHACM
Application of multi-layer compression therapy with application of dHACM.
Procedure: Multi-layer compression therapy
Application of multi-layer compression therapy.
Other: Application of dHACM
Application of dHACM to ulcer.
Application of multi-layer compression therapy without application of dHACM.
Procedure: Multi-layer compression therapy
Application of multi-layer compression therapy.

Primary Outcome Measures :
  1. Time to 100% epithelialization of study ulcer [ Time Frame: 12 weeks ]

Secondary Outcome Measures :
  1. Proportion of patients in both groups with complete wound healing at 12 weeks [ Time Frame: 12 weeks ]

Other Outcome Measures:
  1. Comparison of Quality of Life as assessed by Short Form 36 (SF-36) [ Time Frame: 16 weeks ]
  2. Crossover Subject Analysis [ Time Frame: 12 weeks ]

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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. Index ulcer characteristics:

    1. Full-thickness venous leg ulcer for ≥ 30 days
    2. Ulcer area after debridement is ≥ 1 cm² and ≤ 25 cm² at the randomization visit
    3. Has a clean, granulating base with minimal adherent slough
  2. Subject has completed 14 day run-in period with ≤ 25% wound area reduction post-debridement.
  3. Have one of the following:

    • Ankle Brachial Pressure Index (ABI) > 0.75. (Calculations will be made using measurements from both posterior tibial and dorsalis pedis arteries as well as both arms) OR
    • Have venous insufficiency confirmed by duplex ultrasound examination for valvular or venous incompetence.
  4. Age ≥ 18.
  5. Females of childbearing potential must be willing to use acceptable methods of contraception (birth control pills, barriers, or abstinence).
  6. Ability to read/understand and sign Informed Consent and Release of Medical Information Forms.
  7. Ability to understand and comply with weekly visits and follow-up regimen.

Exclusion Criteria:

  1. Index Ulcer Assessment - Index ulcer meeting the following criteria will not be eligible for enrollment:

    1. Penetrates down to muscle, tendon, or bone
    2. Presence of another venous ulcer ≤ 2 cm from index ulcer
    3. Is deemed by the Investigator to be caused by a medical condition other than venous insufficiency
    4. Exhibits clinical signs and symptoms of infection
    5. If in the opinion of the Investigator, the wound is suspicious for cancer, the subject should undergo an ulcer biopsy to rule out carcinoma. If carcinoma is ruled out, the subject may be re-screened.
    6. Located on the dorsum of the foot or with more than 50% of the ulcer below the malleolus
  2. Prior therapies - Subjects receiving treatment with any of the following will not be eligible for enrollment:

    1. In the last 7 days - Negative pressure wound therapy of the index ulcer
    2. In the last 7 days - Hyperbaric oxygen therapy
    3. 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
    4. In the last 30 days - study ulcer treatment with any advanced therapy, including EpiFix®, tissue engineered materials (e.g. Apligraf® or Dermagraft®), or other scaffold materials (e.g. OASIS® Wound Matrix, MatriStem® Wound Matrix)
    5. In the last 30 days - Subject has been on any investigational drug(s) or therapeutic device(s)
    6. In the last 8 weeks - Amputation or revascularization (surgical or stenting) to the affected leg
    7. Any history of radiation at the ulcer site
    8. Any prior participation in a MiMedx® study
    9. Study ulcer has undergone ≥ 12 months of continuous high strength compression therapy over its duration
  3. Subject criteria that will make subject ineligible for enrollment:

    1. Known osteomyelitis or active cellulitis at wound site
    2. Hemoglobin A1C >12 in the last 60 days prior to randomization
    3. Active malignant disease or subject is less than 1 year disease-free
    4. NYHA Class III and IV congestive heart failure (CHF), as defined by the following criteria: Class III: Symptoms with moderate exertion; Class IV: Symptoms at rest
    5. Auto-immune disorders including Systemic Lupus Erythematosus (SLE), Fibromyalgia, Acquired Immunodeficiency Syndrome (AIDS) or HIV
    6. Allergy or known sensitivity to Aminoglycosides such as gentamicin sulfate and/or streptomycin sulfate
    7. Known allergy to the components of the multi-layer compression bandaging, or who cannot tolerate MLCT
    8. Presence of any condition (including current drug or alcohol abuse, medical or psychiatric condition) that is likely to impair understanding of or compliance with the study protocol in the judgment of the Investigator
    9. Pregnancy at enrollment or within last 6 months, women who are breastfeeding, or women of childbearing potential who are planning to become pregnant during the time of the study OR are unwilling/unable to use acceptable methods of contraception (birth control pills, barriers, or abstinence)

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): NCT02011503

United States, Arizona
Associated Foot & Ankle Specialists, PC
Phoenix, Arizona, United States, 85015
United States, California
ILD Research
Carlsbad, California, United States, 92009
Center for Clinical Research, Inc.
Castro Valley, California, United States, 94546
Center for Clinical Research, Inc.
Fair Oaks, California, United States, 95628
Limb Preservation Platform, Inc.
Fresno, California, United States, 93720
VA Loma Linda Healthcare System
Loma Linda, California, United States, 92357
VA Northern California
Mather, California, United States, 95655
Center for Clinical Research, Inc.
San Francisco, California, United States, 94115
United States, Georgia
Atlanta Veteran's Administration
Decatur, Georgia, United States, 30033
United States, New Jersey
Hackensack University Medical Center
Hackensack, New Jersey, United States, 07601
United States, New York
VA Western New York Health Care System
Buffalo, New York, United States, 14215
United States, Oregon
Center for Clinical Research, Inc.
Eugene, Oregon, United States, 97401
United States, Pennsylvania
SGM Physicians
Haverford, Pennsylvania, United States, 19041
Allegheny-Singer Research Institute
Pittsburgh, Pennsylvania, United States, 15212
United States, South Carolina
William Jennings Bryan Dorn Veterans Affairs Medical Center
Columbia, South Carolina, United States, 29209
Sponsors and Collaborators
MiMedx Group, Inc.
Study Director: Don Fetterolf, MD MiMedx Group, Inc.

Responsible Party: MiMedx Group, Inc. Identifier: NCT02011503     History of Changes
Other Study ID Numbers: EFVLU003
First Posted: December 13, 2013    Key Record Dates
Last Update Posted: March 23, 2017
Last Verified: March 2017

Additional relevant MeSH terms:
Leg Ulcer
Varicose Ulcer
Pathologic Processes
Skin Ulcer
Skin Diseases
Varicose Veins
Vascular Diseases
Cardiovascular Diseases