Polarityte, Inc. ((RGTPQ)) announced an update on their ongoing clinical study.
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PolarityTE, Inc. is conducting a clinical study titled ‘Multi-Center, Prospective, Randomized Controlled Trial Evaluating SkinTE® for the Treatment of Wagner 1 Diabetic Foot Ulcers’ (COVER DFUS II). The study aims to assess the safety and efficacy of SkinTE, an innovative treatment for diabetic foot ulcers, which are a common complication of diabetes. This trial is significant as it could provide a new therapeutic option for patients suffering from these challenging wounds.
The intervention being tested is SkinTE, an Autologous Heterogeneous Skin Construct. It is designed to promote wound healing by using the patient’s own skin cells to regenerate the damaged area. This biological treatment is compared against standard care practices, which include debridement and various dressings.
The study is interventional, with a randomized, parallel assignment model. It is single-blinded, meaning that the outcomes assessors are unaware of which treatment the participants receive. The primary purpose of the study is treatment-focused, aiming to improve healing outcomes for diabetic foot ulcers.
The study began on February 22, 2024, with its primary completion and estimated completion dates yet to be announced. The latest update was submitted on July 8, 2025. These dates are crucial as they indicate the progress and current status of the trial.
From a market perspective, the success of this study could positively influence PolarityTE’s stock performance by validating SkinTE’s effectiveness, potentially increasing investor confidence. It could also impact the competitive landscape by offering a novel solution in the diabetic foot ulcer treatment market.
The study is ongoing, with further details available on the ClinicalTrials portal.