Multi-Center, Prospective, Randomized Controlled Trial Evaluating SkinTE® in the Treatment of Wagner 2 DFUs

SkinTE is an Autologous Heterogeneous Skin Construct (AHSC), which is manufactured from a small piece of healthy full-thickness skin harvested from the patient at the time of randomization to the SkinTE arm. SkinTE is manufactured aseptically by PolarityTE following current Good Manufacturing Practice (cGMP). SkinTE is not cultured ex vivo; rather, it is returned to the provider expeditiously to maintain cellular viability. SkinTE includes various multicellular segments as a result of the manufacturing process. The different multicellular segments contain different types of skin cells, such as keratinocytes, dermal fibroblasts, dermal endothelial cells, and follicular cells, as well as extracellular matrix. The multicellular segments have a surface area-to-volume ratio for improved sustenance by imbibition prior to engraftment.

"Standard care is defined in this protocol to include the following:~* Debridement~* Collagen-alginate primary wound dressing~* Local offloading with felt pad for wounds on weight bearing surfaces~* Foam~* Multi-layer compression dressing~* Off-loading device such as a full-length boot or total contact cast (if full-length boot cannot accommodate the patient) or surgical shoe for ulcers in non-weight bearing locations"