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).
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
105
Application of a non-adherent dressing, a moisture retentive dressing, and a multi-layer compression dressing.
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.
St. Johns Outpatient Wound Center
Tulsa, Oklahoma, United States
Professional Education and Research Institute, Inc.
Roanoke, Virginia, United States
Proportion of ulcers achieving 100% epithelialization in the dHACM group vs other commercially available product and control.
Visitrak Wound Measurement System
Time frame: 6 weeks
Proportion of patients achieving 100% epithelialization in dHACM group vs other commercially available product and control.
Visitrak Wound Measurement System
Time frame: 12 weeks
Cost effectiveness of each treatment modality.
Cost of product x number of visits
Time frame: 12 weeks
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