EPC Silver Wound Gel (EPC-123) Feasibility Study in the Management of Mildly Infected Diabetic Foot Ulcers

Inclusion Criteria: * Diagnosed with diabetes mellitus according to definitions outlined by the American Diabetes Association * Presenting with an active or current foot ulcer that has been identified as stalled or persistent non-healing under current standard-of-care; showing no progression in 2 weeks as per IDSA guidelines. * Presenting with a localized mild or local infection of the ulcer as listed in the IWGDF/IDSA Clinical Practice Guideline for the Diagnosis and Treatment of Diabetic Foot Infections (Table 1); exceeding 0.5 cm2 in area after appropriate debridement. * Subject must agree to adhere to all protocol procedures and must be willing and able to provide written informed consent. * Correction or optimization of underlying medical problems (e.g. diabetes or systemic infection). Exclusion Criteria: * Participants exhibiting extensive gangrene, and/or immediately limb-threatening infection * Indications of osteomyelitis identified by plain radiographs taken within 2 days prior to study entry. * No palpable dorsalis pedis or posterior tibial pulse or a pedal systolic pressure (Doppler ultrasound) of ≤ 40 mm Hg * Clinically significant peripheral arterial disease requiring vascular intervention * Patients requiring renal dialysis, immunosuppressive mediation, or those with uncontrolled hypertension. * Lymphangitis; spread beneath the fascia; muscle, joint, or bone involvement. * IDSA-defined severe infection, including systemic toxicity or metabolic instability * …