NCT03881254

SkinTE™ in the Treatment of Diabetic Foot Wounds

A Multi-center, Randomized Controlled Clinical Trial Evaluating the Effects of SkinTE™ in the Treatment of Wagner One Diabetic Foot Ulcers

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (actual)
• Sponsor: PolarityTE · Industry
• 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 on a commercially available human autologous homologous skin construct 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 collect patient outcome data on a commercially available human autologous homologous skin construct (SkinTE™) with SOC dressing compared to SOC dressings alone in the treatment of Diabetic Foot Wounds (DFU) .The trial will be single blinded in regard to wound healing assessment (another clinician, other than the investigator at each site will assess wound healing) and confirmation of wound healing will be overseen by an independent adjudication committee made up of wound care experts. The study will last thirteen weeks, with a two week screening period prior to enrollment. 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 the experimental wound care covering with human autologous,homologous skin construct (SkinTE™ 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
• Diabetic Foot Ulcer
• Ulcer Foot

Interventions

Type	Name	Description
OTHER	Human Autologous Homologous Skin Construct	Application of a autologous human derived skin polar units
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: 2019-04-02
• Primary completion: 2021-07-28
• Completion: 2021-07-28
• First posted: 2019-03-19
• Last updated: 2021-08-26

Locations

1 site across 1 country: United States