Clinical trial NCT02011503: Use of dHACM in the Treatment of Venous Leg Ulcers
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Leg Ulcer
Lead sponsor: MiMedx Group, Inc.
Sponsor class: INDUSTRY
First posted: 2013-12-13
Enrollment: 128
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).


Eligibility 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)

Primary outcomes:
measure: Time to 100% epithelialization of study ulcer
timeFrame: 12 weeks
Secondary outcomes:
measure: Proportion of patients in both groups with complete wound healing at 12 weeks
timeFrame: 12 weeks
Other outcomes:
measure: Comparison of Quality of Life as assessed by Short Form 36 (SF-36)
timeFrame: 16 weeks
measure: Crossover Subject Analysis
timeFrame: 12 weeks
Locations:
city: Phoenix
country: United States
facility: Associated Foot & Ankle Specialists, PC
state: Arizona
city: Carlsbad
country: United States
facility: ILD Research
state: California
city: Castro Valley
country: United States
facility: Center for Clinical Research, Inc.
state: California
city: Fair Oaks
country: United States
facility: Center for Clinical Research, Inc.
state: California
city: Fresno
country: United States
facility: Limb Preservation Platform, Inc.
state: California
city: Loma Linda
country: United States
facility: VA Loma Linda Healthcare System
state: California
city: Mather
country: United States
facility: VA Northern California
state: California
city: San Francisco
country: United States
facility: Center for Clinical Research, Inc.
state: California
city: Decatur
country: United States
facility: Atlanta Veteran's Administration
state: Georgia
city: Hackensack
country: United States
facility: Hackensack University Medical Center
state: New Jersey
city: Buffalo
country: United States
facility: VA Western New York Health Care System
state: New York
city: Eugene
country: United States
facility: Center for Clinical Research, Inc.
state: Oregon
city: Haverford
country: United States
facility: SGM Physicians
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Allegheny-Singer Research Institute
state: Pennsylvania
city: Columbia
country: United States
facility: William Jennings Bryan Dorn Veterans Affairs Medical Center
state: South Carolina
Study officials:
affiliation: MiMedx Group, Inc.
name: Don Fetterolf, MD
role: STUDY_DIRECTOR
References: