SkinTE™ in the Treatment of Diabetic Foot Wounds
Last updated on July 2021Recruitment
- Recruitment Status
- Active, not recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Diabetic Foot
- Diabetic Foot Ulcer
- Ulcer Foot
- Type
- Interventional
- Phase
- Not Applicable
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentIntervention Model Description: Multi-center, Randomized Controlled Clinical Trial Evaluating the Effect of Human Homologous Autologous Skin Construct (SkinTE™) in the Treatment of Diabetic Foot UlcersMasking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Both males and females
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) .T...
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).
Tracking Information
- NCT #
- NCT03881254
- Collaborators
- Professional Education and Research Institute
- Investigators
- Principal Investigator: David Armstrong, DPM, MD, PhD USC / Salsa