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

MiMedx Group, Inc.12 sites in 1 country128 target enrollmentMarch 2014

ConditionsLeg Ulcer

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Leg Ulcer
Sponsor: MiMedx Group, Inc.
Enrollment: 128
Locations: 12
Primary Endpoint: Time to 100% epithelialization of study ulcer
Status: Completed
Last Updated: 7 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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).

Registry

clinicaltrials.gov

Start Date

March 2014

End Date

November 30, 2017

Last Updated

7 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

MiMedx Group, Inc.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•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.
•(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.
•Females of childbearing potential must be willing to use acceptable methods of contraception (birth control pills, barriers, or abstinence).

Exclusion Criteria

•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