Study of Cold Atmospheric Plasma Plus Endovascular Treatment for Diabetic Foot Ulcers with Lower Limb Artery Blockage Evaluating Healing and Safety in Adults Aged 18 to 80

What this Trial Is About

This research aims to evaluate whether combining cold atmospheric plasma CAP therapy with endovascular intervention can speed up wound healing and improve safety in adults aged 18 to 80 with diabetic foot ulcers DFUs complicated by lower extremity arterial blockage. The study compares CAP treatment plus standard care to placebo sham CAP plus standard care to investigate if CAP leads to greater ulcer area reduction and fewer adverse local symptoms. The trial is randomized, double-blind, and placebo-controlled to ensure reliable results. Participants receive either active CAP therapy or sham CAP therapy once daily for 10 days following successful balloon angioplasty of infrapopliteal arteries. CAP treatment involves applying CAP-activated gas for 25 minutes per session using a specialized device. Sham CAP uses identical equipment without plasma activation to maintain blinding. All participants continue to receive guideline-based standard diabetic foot ulcer care throughout the study. During the study, participants undergo daily wound assessments to measure ulcer size, infection signs, and pain levels. Quality of life questionnaires EQ-5D and SF-12 are completed at the start and at Week 4. The main outcome measured is the change in ulcer area from baseline through Day 10 and Week 4. Researchers also monitor pain scores, time to early healing, quality of life changes, and local adverse events. The study follow-up period is 4 weeks after randomization to evaluate efficacy and safety outcomes.

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