Use of dHACM in the Treatment of Venous Leg Ulcers

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2016 by MiMedx Group, Inc.
Sponsor:
Information provided by (Responsible Party):
MiMedx Group, Inc.
ClinicalTrials.gov Identifier:
NCT02011503
First received: November 21, 2013
Last updated: June 16, 2016
Last verified: June 2016
  Purpose
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 Intervention
Leg Ulcer
Procedure: Multi-layer compression therapy
Other: Application of dHACM

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by MiMedx Group, Inc.:

Primary Outcome Measures:
  • Time to 100% epithelialization of study ulcer [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Proportion of patients in both groups with complete wound healing at 12 weeks [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Other Outcome Measures:
  • Comparison of Quality of Life as assessed by Short Form 36 (SF-36) [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
  • Crossover Subject Analysis [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 120
Study Start Date: March 2014
Estimated Study Completion Date: December 2016
Estimated Primary Completion Date: December 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
Control
Application of multi-layer compression therapy without application of dHACM.
Procedure: Multi-layer compression therapy
Application of multi-layer compression therapy.

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02011503

Contacts
Contact: Don Fetterolf, MD 678-384-6720

Locations
United States, Arizona
Associated Foot & Ankle Specialists, PC Recruiting
Phoenix, Arizona, United States, 85015
Contact: Beverlee Bennett    602-274-4100      
United States, California
ILD Research Recruiting
Carlsbad, California, United States, 92009
Contact: Irene Vayser    760-350-5080      
Center for Clinical Research, Inc. Recruiting
Castro Valley, California, United States, 94546
Contact: Gayana Sarkisova    800-363-1069      
Center for Clinical Research, Inc. Recruiting
Fair Oaks, California, United States, 95628
Contact: Tanya Tovmassian    800-363-1069      
Limb Preservation Platform, Inc. Recruiting
Fresno, California, United States, 93720
Contact: Destiny Stegall    559-431-1700      
VA Loma Linda Healthcare System Recruiting
Loma Linda, California, United States, 92357
Contact: Vicki Bishop    909-825-7084      
Center for Clinical Research, Inc. Recruiting
San Francisco, California, United States, 94115
Contact: Gayana Sarkisova    800-363-1069      
United States, Georgia
Atlanta Veteran's Administration Completed
Decatur, Georgia, United States, 30033
United States, New Jersey
Hackensack University Medical Center Recruiting
Hackensack, New Jersey, United States, 07601
Contact: Susan Mathus    551-996-5722      
United States, New York
VA Western New York Health Care System Recruiting
Buffalo, New York, United States, 14215
Contact: Jennifer Kress    716-862-6092      
United States, Oregon
Center for Clinical Research, Inc. Recruiting
Eugene, Oregon, United States, 97401
Contact: Robert Porter    800-363-1069      
United States, Pennsylvania
SGM Physicians Recruiting
Haverford, Pennsylvania, United States, 19041
Contact: Lucinda Little    610-642-5040      
Allegheny-Singer Research Institute Recruiting
Pittsburgh, Pennsylvania, United States, 15212
Contact: Laurie Machen    412-359-6181      
United States, South Carolina
William Jennings Bryan Dorn Veterans Affairs Medical Center Recruiting
Columbia, South Carolina, United States, 29209
Contact: Joanna Sneed    803-776-4000      
Sponsors and Collaborators
MiMedx Group, Inc.
Investigators
Study Director: Don Fetterolf, MD MiMedx Group, Inc.
  More Information

Responsible Party: MiMedx Group, Inc.
ClinicalTrials.gov Identifier: NCT02011503     History of Changes
Other Study ID Numbers: EFVLU003 
Study First Received: November 21, 2013
Last Updated: June 16, 2016
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on July 26, 2016