SkinTE® in the Treatment of Venous Leg Wounds

Venous Leg Ulcer Clinical Trial

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

Status Completed

Clinical Trial 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

Clinical Trial 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). ;

Related Conditions & MeSH terms

• Leg Ulcer
• Ulcer
• Varicose Ulcer
• Venous Leg Ulcer
• Venous Stasis
• Venous Stasis Ulcer

• NCT number: NCT03881267
• Study type: Interventional
• Source: PolarityTE
• Status: Completed
• Phase: N/A
• Start date: March 29, 2019
• Completion date: March 23, 2021