NCT01921491

DHACM vs Other Commercially Available Treatments

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 105 (actual)
• Sponsor: MiMedx Group, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to determine whether dehydrated human amnion/chorion membrane (dHACM) is more effective than another commercially available product or conservative measures alone when used to treat diabetic foot ulcers (DFUs).

Detailed description

This is a prospective, stratified, randomized, controlled, comparative, parallel group, multi-center clinical trial comparing the proportion of ulcers completely healed by use of dehydrated human amnion/chorion membrane (dHACM) placed weekly versus placement of bioengineered skin substitute (BSS) placed weekly, versus standard of care in diabetic patients with a diabetic foot ulcer who have adequate arterial perfusion as defined in section, 2.0 (Patient Eligibility), for wound healing to the affected limb.

Conditions

• Diabetic Foot Ulcer

Interventions

Type	Name	Description
PROCEDURE	Dressing Application	Application of a non-adherent dressing, a moisture retentive dressing, and a multi-layer compression dressing.
DEVICE	Offloading	Provision of offloading cast walker or similar sponsor-approved device. May convert into "instant total contact cast" and/or add felt/foam to supplement offloading.

Timeline

• Start date: 2013-08-01
• Primary completion: 2015-09-01
• Completion: 2015-09-01
• First posted: 2013-08-13
• Last updated: 2020-11-04

Locations

2 sites across 1 country: United States