Use of dHACM in the Treatment of Venous Leg Ulcers

NCT02011503 | Completed

• 1 other identifier: EFVLU003
• Study Type: interventional
• Target: 128
• Locations: 1 country
• Sites: 15

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).

Conditions

Leg Ulcer

Outcome Measures

Primary Outcomes (1)

• Time to 100% epithelialization of study ulcer

  12 weeks

Secondary Outcomes (1)

• Proportion of patients in both groups with complete wound healing at 12 weeks

  12 weeks

Other Outcomes (2)

• Comparison of Quality of Life as assessed by Short Form 36 (SF-36)

  16 weeks

• Crossover Subject Analysis

  12 weeks

Study Arms (2)

dHACM

EXPERIMENTAL

Application of multi-layer compression therapy with application of dHACM.

Procedure: Multi-layer compression therapy; Other: Application of dHACM

Control

OTHER

Application of multi-layer compression therapy without application of dHACM.

Procedure: Multi-layer compression therapy

Interventions

Multi-layer compression therapy PROCEDURE

Application of multi-layer compression therapy.

Control; dHACM

Application of dHACM OTHER

Application of dHACM to ulcer.

dHACM

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Index ulcer characteristics:
• Full-thickness venous leg ulcer for ≥ 30 days
• Ulcer area after debridement is ≥ 1 cm² and ≤ 25 cm² at the randomization visit
• Has a clean, granulating base with minimal adherent slough
• Subject has completed 14 day run-in period with ≤ 25% wound area reduction post-debridement.
• 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.
• Age ≥ 18.
• Females of childbearing potential must be willing to use acceptable methods of contraception (birth control pills, barriers, or abstinence).
• Ability to read/understand and sign Informed Consent and Release of Medical Information Forms.
• Ability to understand and comply with weekly visits and follow-up regimen.

You may not qualify if:

• Index Ulcer Assessment - Index ulcer meeting the following criteria will not be eligible for enrollment:
• Penetrates down to muscle, tendon, or bone
• Presence of another venous ulcer ≤ 2 cm from index ulcer
• Is deemed by the Investigator to be caused by a medical condition other than venous insufficiency
• Exhibits clinical signs and symptoms of infection
• 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.
• Located on the dorsum of the foot or with more than 50% of the ulcer below the malleolus
• Prior therapies - Subjects receiving treatment with any of the following will not be eligible for enrollment:
• In the last 7 days - Negative pressure wound therapy of the index ulcer
• In the last 7 days - Hyperbaric oxygen therapy
• 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
• 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)
• In the last 30 days - Subject has been on any investigational drug(s) or therapeutic device(s)
• In the last 8 weeks - Amputation or revascularization (surgical or stenting) to the affected leg
• Any history of radiation at the ulcer site

Sponsors & Collaborators

• MiMedx Group, Inc.: lead

Study Sites (15)

Associated Foot & Ankle Specialists, PC

Phoenix, Arizona, 85015, United States

Location

ILD Research

Carlsbad, California, 92009, United States

Location

Center for Clinical Research, Inc.

Castro Valley, California, 94546, United States

Location

Center for Clinical Research, Inc.

Fair Oaks, California, 95628, United States

Location

Limb Preservation Platform, Inc.

Fresno, California, 93720, United States

Location

VA Loma Linda Healthcare System

Loma Linda, California, 92357, United States

Location

VA Northern California

Mather, California, 95655, United States

Location

Center for Clinical Research, Inc.

San Francisco, California, 94115, United States

Location

Atlanta Veteran's Administration

Decatur, Georgia, 30033, United States

Location

Hackensack University Medical Center

Hackensack, New Jersey, 07601, United States

Location

VA Western New York Health Care System

Buffalo, New York, 14215, United States

Location

Center for Clinical Research, Inc.

Eugene, Oregon, 97401, United States

Location

SGM Physicians

Haverford, Pennsylvania, 19041, United States

Location

Allegheny-Singer Research Institute

Pittsburgh, Pennsylvania, 15212, United States

Location

William Jennings Bryan Dorn Veterans Affairs Medical Center

Columbia, South Carolina, 29209, United States

Location

MeSH Terms

Conditions

Leg Ulcer

Condition Hierarchy (Ancestors)

Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Don Fetterolf, MD

  MiMedx Group, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 21, 2013
• First Posted: December 13, 2013
• Study Start: March 1, 2014
• Primary Completion: August 5, 2017
• Study Completion: November 30, 2017
• Last Updated: August 24, 2018

Record last verified: 2018-08

Locations

US (15)