SkinTE™ in the Treatment of Diabetic Foot Wounds

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 Diabetic Foot 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 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). ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT03881254
Study type	Interventional
Source	PolarityTE
Contact
Status	Completed
Phase	N/A
Start date	April 2, 2019
Completion date	July 28, 2021

View Details

See also
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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.