Study of Cold Atmospheric Plasma with Endovascular Treatment for Diabetic Foot Ulcers and Arterial Blockage in the Lower Limbs

What this Trial Is About

Critical limb ischemia is a severe form of peripheral arterial disease often seen in patients with diabetes, leading to painful ulcers, tissue damage, and sometimes amputation. This study investigates the use of cold atmospheric plasma CAP combined with endovascular intervention to treat diabetic foot ulcers complicated by lower extremity arterial occlusion. The study aims to assess whether this combination can improve healing outcomes and provide safer, more effective care for patients facing high risks from current therapies. Participants will receive successful infrapopliteal angioplasty to restore blood flow in affected arteries. They will then be randomly assigned to receive either CAP therapy or a sham procedure. CAP treatment involves daily sessions for the first five days, followed by every other day for a total of 13 sessions, each lasting about 25 minutes. The CAP device delivers ozone-rich plasma followed by nitric oxide-rich plasma to promote disinfection and healing. The sham procedure mimics the treatment sounds without producing plasma, ensuring blinding. Throughout the 21-day study period, researchers will monitor ulcer size, time to reduction, infection signs, pain levels, and quality of life using questionnaires. Safety will be tracked by recording skin irritation, bleeding, and burning sensations. Assessments include vascular imaging and clinical evaluations to measure treatment effects on wound healing and blood flow, with the goal of gathering evidence for CAPs role alongside endovascular techniques in diabetic foot care.

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