NCT03881267

SkinTE® in the Treatment of Venous Leg Wounds

A Multi-center, Randomized Controlled Clinical Trial Evaluating the Effects of SkinTE® in the Treatment of Venous Leg Ulcers

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 29 (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 Venous Leg 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 Venous Leg Wounds (VLU). 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 twelve 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 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 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

• Venous Leg Ulcer
• Venous Stasis
• Venous Stasis Ulcer

Interventions

Type	Name	Description
OTHER	Human Autologous Homologous Skin Construct	Application of a autologous human derived skin polar units
OTHER	Additional Outer Dressing Application	Application of Moisture retentive dressing, and a multi-layer compression dressing
OTHER	Fibracol Wound Dressing	Application of Collagen Alginate Dressing

Timeline

• Start date: 2019-03-29
• Primary completion: 2021-03-23
• Completion: 2021-03-23
• First posted: 2019-03-19
• Last updated: 2022-04-04

Locations

2 sites across 1 country: United States