Efficacy and Safety of Cold Atmospheric Plasma Combined With Endovascular Intervention for Diabetic Foot Ulcers With Lower Extremity Arterial Occlusion

The goal of this clinical trial is to evaluate whether cold atmospheric plasma (CAP) combined with endovascular intervention can accelerate wound healing and improve safety outcomes in patients aged 18 to 80 years with diabetic foot ulcers (DFUs) complicated by lower extremity arterial occlusion. The main questions it aims to answer are: 1. Does CAP treatment lead to a greater reduction in ulcer area by Week 4 compared to placebo?; 2. Is CAP therapy safe and well-tolerated in patients with DFUs after successful infrapopliteal revascularisation?; Researchers will compare CAP treatment plus standard care to sham CAP (placebo) plus standard care to see if CAP improves wound healing more effectively and reduces adverse local symptoms. Participants will: 1. Receive either active CAP therapy or sham CAP therapy once daily for 10 days following endovascular revascularisation 2. Undergo daily wound assessments for ulcer area, signs of infection, and pain scores 3. Complete quality-of-life questionnaires (EQ-5D and SF-12) at baseline and Week 4 4. Be followed through Week 4 to assess efficacy and safety endpoints

NCT Number	NCT07198061
Lead Sponsor	Shenyang Medical College Collaborators: Ansteel Group General Hospital
Conditions	Diabetic Foot Ulcers (DFU), Lower Extremity Arterial Occlusion
Enrollment	40 participants
Start Date	2025-10-09
Primary Completion	2026-11-20 (estimated)
Study Completion	2026-12-30 (estimated)
Updated on ClinicalTrials.gov	2026-04-22