Use of dHACM in the Treatment of Venous Leg Ulcers

Leg Ulcer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02011503
• Other study ID #: EFVLU003
• Status: Completed
• Phase: N/A
• Start date: March 2014
• Est. completion date: November 30, 2017

Study information

• Verified date: August 2018
• Source: MiMedx Group, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 128
• Est. completion date: November 30, 2017
• Est. primary completion date: August 5, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Leg Ulcer
• Ulcer
• Varicose Ulcer

Intervention

Procedure:
• Multi-layer compression therapy
Application of multi-layer compression therapy.

Other:
• Application of dHACM
Application of dHACM to ulcer.

Locations

Country	Name	City	State
United States	VA Western New York Health Care System	Buffalo	New York
United States	ILD Research	Carlsbad	California
United States	Center for Clinical Research, Inc.	Castro Valley	California
United States	William Jennings Bryan Dorn Veterans Affairs Medical Center	Columbia	South Carolina
United States	Atlanta Veteran's Administration	Decatur	Georgia
United States	Center for Clinical Research, Inc.	Eugene	Oregon
United States	Center for Clinical Research, Inc.	Fair Oaks	California
United States	Limb Preservation Platform, Inc.	Fresno	California
United States	Hackensack University Medical Center	Hackensack	New Jersey
United States	SGM Physicians	Haverford	Pennsylvania
United States	VA Loma Linda Healthcare System	Loma Linda	California
United States	VA Northern California	Mather	California
United States	Associated Foot & Ankle Specialists, PC	Phoenix	Arizona
United States	Allegheny-Singer Research Institute	Pittsburgh	Pennsylvania
United States	Center for Clinical Research, Inc.	San Francisco	California

Sponsors (1)

Lead Sponsor	Collaborator
MiMedx Group, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Comparison of Quality of Life as assessed by Short Form 36 (SF-36)		16 weeks
Other	Crossover Subject Analysis		12 weeks
Primary	Time to 100% epithelialization of study ulcer		12 weeks
Secondary	Proportion of patients in both groups with complete wound healing at 12 weeks		12 weeks