AOTI, Inc. ((GB:AOTI)) announced an update on their ongoing clinical study.
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The clinical study titled A Multi-national, Prospective, Randomized, Double Blinded, Placebo-controlled Trial to Evaluate Cyclical Topical Wound Oxygen Therapy (TWO2) in the Treatment of Chronic Venous Leg Ulcers aims to assess the efficacy, safety, and economic benefits of TWO2 Therapy for venous leg ulcers. This study is significant as it explores a potentially effective treatment for a common and challenging condition.
The intervention being tested is the Topical Wound Oxygen Therapy device, which delivers cyclical oxygen pressure to the wound site. This device is compared against a sham control that mimics the treatment without delivering oxygen, to evaluate its true effectiveness.
The study is designed as a randomized, double-blinded, placebo-controlled trial with a parallel intervention model. Participants, care providers, investigators, and outcomes assessors are all blinded to the treatment allocation, ensuring unbiased results. The primary purpose of the study is treatment-focused.
The study began on December 16, 2024, with the latest update submitted on January 30, 2025. These dates are crucial for tracking the study’s progress and ensuring timely updates for stakeholders.
This study update could positively impact AOTI, Inc.’s stock performance and investor sentiment, as successful results may lead to a competitive advantage in the wound care market. Investors should watch for further developments, especially in comparison to other industry players.
The study is ongoing, with further details available on the ClinicalTrials portal.