Evaluate the Efficacy and Safety of Xianglei Tangzu Gao for the Treatment of Wagner Grade II Diabetic Foot Ulcers
Trial Parameters
Brief Summary
This is a phase II/III seamless design, randomized, double-blind, paralleled-group, placebo-controlled study to evaluate the efficacy and safety of Xianglei Tangzu Gao for the treatment of Wagner grade II diabetic foot ulcers. The primary endpoint is the proportion of subjects with complete closure of target ulcer during the 16-week treatment phase.
Eligibility Criteria
Inclusion Criteria: 1. Subjects, male or female, aged 18 to 80 years (inclusive) with Type 1 or Type 2 diabetes undergoing therapy for glycemic control using available diabetes drugs including insulin. 2. Subject has a glycosylated hemoglobin, HbA1c ≤ 12%. 3. Diagnosis with Diabetic Peripheral Neuropathy (DPN) or vascular disease defined by Chinese guidelines for diagnosis and treatment of diabetic foot (2020 version). Subject has adequate vascular perfusion of the affected limb, no obvious clinical manifestations of lower limb ischemia, confirmed by Ankle-Brachial Index (ABI) ≥ 0.8 and ≤ 1.3, or transcutaneous pressure of oxygen (TcPO2) \> 30 mmHg on at least one lead. 4. An ulcer of Wagner Grade II. 5. Presence of at least one diabetic foot ulcer that meets all of the following criteria: 1. Ulcer size (area) is \> 1 cm2 and ≤ 25 cm2 (post-debridement at time of screening and randomization) 2. Ulcer is located on or below the malleoli and presents duration of between 4 weeks and 12 mo