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

Launched by SHENYANG MEDICAL COLLEGE · Jul 9, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment approach for people with diabetic foot ulcers—open sores that can develop on the feet of people with diabetes—and poor blood flow in the legs caused by blocked arteries. The study is looking at whether adding a therapy called cold atmospheric plasma (CAP), which uses a special type of energized gas to help kill bacteria and promote healing, can improve recovery when combined with a common procedure that opens blocked blood vessels in the legs. The goal is to see if this combination is safe and helps these hard-to-heal wounds get better.

To take part, participants need to be adults aged 18 to 80 with diabetes and a foot ulcer that hasn’t healed for at least three weeks despite standard treatment. They must have confirmed blockages in leg arteries that have been successfully treated with a procedure to open the vessels. People with certain other treatments or health conditions, like dialysis or active infections treated with antibiotics, may not be eligible. If you join the trial, you will receive the usual blood vessel opening treatment plus the CAP therapy, and doctors will monitor your wound healing and overall health to see how well this new combination works. This study is not yet recruiting, but it aims to provide better options for people struggling with these serious foot ulcers.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Aged 18-80 years, with a diagnosis of type 1 or type 2 diabetes and diabetic foot ulcer; glycated hemoglobin (HbA1c) ≤ 10%.
• • Presence of at least one chronic foot ulcer persisting for at least three weeks, with no signs of healing after standard-of-care treatment based on current clinical guidelines. The ulcer must be classified as Wagner-Armstrong grade 1D or 2D (Wagner: superficial ulcer \[grade 1\] or ulcer extending to tendon \[grade 2\]; Armstrong: presence of both ischaemia and infection \[stage D\]).
• • Documented infrapopliteal arterial stenosis or occlusion by vascular ultrasound and/or CT angiography (CTA), meeting indications for revascularization. All enrolled patients must have received successful infrapopliteal balloon angioplasty, with intraoperative angiography confirming target artery patency.
• • Provision of written informed consent.
• Exclusion Criteria:
• • Concurrent treatment of the wound with local vacuum therapy or maggot therapy.
• • Undergoing dialysis.
• • Use of local active antibiotics.
• • Treatment with platelet-rich fibrin.
• • Women of childbearing potential without effective contraception, or women who are actively breastfeeding.
• • Presence of other severe organ dysfunction, with an expected survival of less than six months.
• • Participation in another clinical trial within the past three months or currently enrolled in another clinical trial.