Background: Diabetic foot ulcers (DFUs) are chronic wounds that contribute significantly to morbidity, mortality, and healthcare costs. Despite current standard-of-care (SOC) approaches, healing rates re-main suboptimal, emphasizing the urgent need for innovative and cost-effective treatment options.

Methods: An interim analysis of this multicenter, prospective, randomized controlled platform clinical trial evaluated the efficacy of multiple lyophilized human amnion/chorion membrane (LHACMs) with SOC versus SOC alone. The primary endpoint was percentage of target ulcers achieving complete wound closure in 12 weeks, defined as 100% reepithelialization without drainage for two consecutive weeks, confirmed by blinded independent review.

Type 2 diabetes mellitus (T2DM) represents the predominant form of diabetes, comprising the majority of the over 500 million cases globally.1

Its growing prevalence is largely driven by modifiable risk factors such as obesity, poor metabolic health, sedentary behavior, tobacco use, and alcohol consumption.2

One of its most debilitating complications is the development of diabetic foot ulcers (DFUs), which result from factors such as excessive plantar pressure, ill-fitting footwear, abnormal gait, and repetitive trauma.3

Evaluation and classification of DFUs typically take into account ulcer size and depth, severity of infection, presence of peripheral neuropathy or peripheral arterial disease, and anatomical location.