NCT04040426

Bioactive Split Thickness Skin Allograft Versus Standard of Care in the Treatment of Diabetic Foot Ulcers

A Multi-center, Randomized Controlled ClinicalTrial Evaluating a Unique Bioactive SplitThickness Skin Allograft Versus Standard of Care in the Treatment of Diabetic Foot Ulcers

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (actual)
• Sponsor: Professional Education and Research Institute · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

This study is a prospective, multi-center, randomized controlled trial designed to collect patient outcome data as well as assess performance and safety of a commercially available human split thickness skin allograft with SOC dressing compared to SOC dressings alone in the treatment of Diabetic Foot Wounds.

Detailed description

This study is a prospective, multi-center, Randomized Controlled Trial ( RCT ) designed to assess performance and safety and collect patient outcome data on a commercially available human split thickness skin allograft (Theraskin™) with SOC dressing compared to SOC dressings alone in the treatment of Diabetic Foot Wounds (DFU) . The study will last thirteen weeks, with a two week screening period prior to enrollment. Theraskin™ is an allograft tissue and will be used in compliance with homologous use by the FDA under section 361 of the PHS Act and 21 CFR Part 1271. There are two arms in the study: Arm 1: The Experimental Arm , that will include SOC Therapy. SOC therapy in this study is offloading of the DFU (CAM boots or total contact casting \[TCC\] if the subject's foot is too large for a CAM), appropriate sharp or surgical debridement, infection management (systemic antibiotics only in conjunction with debridement) and application of human split thickness skin allograft (Theraskin™) followed by a moisture retention dressing and a padded 3-layer dressing comprised of 4x4 gauze pads, soft roll and compression wrap (DynaflexTM or equivalent). Arm 2: The Standard of Care Arm. The SOC therapy in this study is offloading of the DFU (CAM boots or total contact casting \[TCC\] if the subject's foot is too large for a CAM), appropriate sharp or surgical debridement, infection management (systemic antibiotics only in conjunction with debridement) and wound care covering with calcium alginate Fibracol dressing followed by a moisture retentive dressing and a padded 3-layer dressing comprised of 4x4 gauze pads, soft roll and compressive wrap (DynaflexTM or equivalent).

Conditions

• Diabetic Foot
• Ulcer Foot

Interventions

Type	Name	Description
OTHER	Human split thickness skin allograft	Application of a fenestrated human skin graft
OTHER	Additional Outer Dressing Applicaiton	Application of Moisture retentive dressing, and a multi-layer compression dressing
OTHER	Offloading	Patient will be offloaded in a diabetic camboot after treatment, or total contact cast if patient cannot be fit with diabetic offloading boot
OTHER	Fibracol Wound Dressing	Application of Collagen Alginate Dressing

Timeline

• Start date: 2019-08-06
• Primary completion: 2021-09-14
• Completion: 2021-10-01
• First posted: 2019-07-31
• Last updated: 2022-01-28

Locations

5 sites across 1 country: United States