Clinical Research
Wound care has become an increased focus as the prevalence of chronic wounds continues to increase to epidemic proportions. Current care practices lack standardization and randomized clinical trial results to guide best practices. There is a critical need for multidisciplinary collaboration and research to effectively establish evidenced based wound care protocols to optimally treat chronic wounds, including diabetic foot ulcers (DFUs).1,2
We present 3 subjects who completed an ongoing clinical trial (funded by Naval Medical Research Command - Naval Advanced Medical Development via Medical Technology Enterprise Consortium) entitled “Randomized Clinical Trial to Compare Transforming Powder Dressing (TPD) and Standard of Care (SOC) Dressing Therapies to Heal Diabetic Foot Ulcers”.
Methods: Prospective, multi-center, open-label, interventional study comparing the effectiveness of TPD treatment to SOC dressings in subjects with Wagner Grade 1 and 2 DFUs. The primary objective is to evaluate the incidence of wound closure in subjects in up to 12-weeks of treatment. Secondary objectives include evaluation of wound healing trajectories, infections, subject satisfaction, pain and quality of life, comparing both groups.
This case series presents results of 3 subjects (from one site) with diabetes type 2, Wagner Grade 2 DFUs refractory to SOC, who were randomized to TPD.