Transparency Life Sciences and Lakewood Amedex Launch Protocol Design for New Clinical Trial on Chronic Diabetic Foot Ulcers

New approach prioritizes patient and physician feedback during trial design to more effectively reach milestones sooner

June 03, 2020 08:02 AM Eastern Daylight Time

BOSTON & SARASOTA, Fla.–(BUSINESS WIRE)–Transparency Life Sciences (TLS) today announced a partnership with the Lakewood Amedex Inc. for crowdsourced design of a Phase 2a/b protocol to test a novel class of synthetic broad-spectrum antimicrobials and antifungals for the treatment of Chronic Diabetic Foot Ulcers (cDFU). The partnership uses TLS’ novel patient-centric protocol builder for clinical trials called Transparency Protocol Crowdsourcing© (TPC) to solicit input from patients, caregivers, and health care professionals to contribute to the setup and design of trials using a proprietary online survey tool. The results are then analyzed using AI-enabled natural language processing and TLS’ proprietary advanced analytic tools to draft protocols more relevant to patient needs and clinical practice.

Diabetic foot infections are one of the most common complications for people who suffer from diabetes and a frequent cause of hospitalization. According to the American Diabetes Association, approximately 8.3 percent of the US population suffers from diabetes, and in 2006 there were 65,700 nontraumatic amputations performed on diabetic patients. Earlier trials of the Lakewood Amedex therapy indicated it was well tolerated for safety and the cohort treated with the 2 percent solution demonstrated improvement in ulcer healing in the small number of subjects. For the next phase, Lakewood Amedex has partnered with TLS to discover optimal protocol preferences for a variety of voices involved in the study, from patients to providers to caregivers. The survey will ask for feedback on dosing intervals, delivery mechanisms, and inclusion/exclusion criteria.

“Patients needing treatment for cDFU face many obstacles, as mobility and dependency on others is a big part of their care, in addition to their own suffering from the condition itself,” said Harry Glorikian,

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