Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
128 participants
INTERVENTIONAL
2014-03-31
2017-11-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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dHACM
Application of multi-layer compression therapy with application of dHACM.
Multi-layer compression therapy
Application of multi-layer compression therapy.
Application of dHACM
Application of dHACM to ulcer.
Control
Application of multi-layer compression therapy without application of dHACM.
Multi-layer compression therapy
Application of multi-layer compression therapy.
Interventions
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Multi-layer compression therapy
Application of multi-layer compression therapy.
Application of dHACM
Application of dHACM to ulcer.
Eligibility Criteria
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Inclusion Criteria
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. 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)
18 Years
ALL
No
Sponsors
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MiMedx Group, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Don Fetterolf, MD
Role: STUDY_DIRECTOR
MiMedx Group, Inc.
Locations
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Associated Foot & Ankle Specialists, PC
Phoenix, Arizona, United States
ILD Research
Carlsbad, California, United States
Center for Clinical Research, Inc.
Castro Valley, California, United States
Center for Clinical Research, Inc.
Fair Oaks, California, United States
Limb Preservation Platform, Inc.
Fresno, California, United States
VA Loma Linda Healthcare System
Loma Linda, California, United States
VA Northern California
Mather, California, United States
Center for Clinical Research, Inc.
San Francisco, California, United States
Atlanta Veteran's Administration
Decatur, Georgia, United States
Hackensack University Medical Center
Hackensack, New Jersey, United States
VA Western New York Health Care System
Buffalo, New York, United States
Center for Clinical Research, Inc.
Eugene, Oregon, United States
SGM Physicians
Haverford, Pennsylvania, United States
Allegheny-Singer Research Institute
Pittsburgh, Pennsylvania, United States
William Jennings Bryan Dorn Veterans Affairs Medical Center
Columbia, South Carolina, United States
Countries
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Other Identifiers
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EFVLU003
Identifier Type: -
Identifier Source: org_study_id
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