Cold atmospheric plasma plus endovascular treatment for diabetic foot ulcers with lower-leg artery blockages

Efficacy and Safety of Cold Atmospheric Plasma Combined With Endovascular Intervention for Diabetic Foot Ulcers With Lower Extremity Arterial Occlusion: A Randomized, Double-Blind, Placebo-Controlled Trial

This will test whether adding cold atmospheric plasma after endovascular revascularisation helps heal diabetic foot ulcers in adults with lower-extremity arterial occlusion.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 40 (estimated)
• Ages: 18 Years to 80 Years
• Sex: All
• Sponsor: Shenyang Medical College (other)
• Locations: 1 site (Anshan, Liaoning)
• Trial ID: NCT07198061 on ClinicalTrials.gov

What this trial studies

This is a prospective, randomized, placebo-controlled, single-center trial comparing active cold atmospheric plasma (CAP) therapy to sham CAP, each given once daily for 10 days in addition to guideline-based standard DFU care after successful infrapopliteal balloon angioplasty. The primary outcome is percent reduction in ulcer area at Week 4, with secondary outcomes including time to early healing response, pain scores, quality of life, and local adverse events. Participants will undergo daily wound assessments and standardized follow-up to monitor safety and wound metrics. The trial enrolls adults with chronic diabetic foot ulcers who meet imaging-confirmed infrapopliteal stenosis/occlusion and achieved ≤30% residual stenosis after revascularisation.

Who should consider this trial

Good fit: Adults aged 18–80 with type 1 or 2 diabetes, HbA1c ≤10%, a chronic foot ulcer (≥3 weeks) of Wagner-Armstrong grade 1D–2D, and successful infrapopliteal balloon angioplasty (≤30% residual stenosis) are ideal candidates.

Not a fit: Patients on dialysis, those using negative pressure wound therapy, maggot debridement, topical antibiotics with biologic activity, or platelet-rich fibrin for the wound—and patients who cannot undergo or did not have successful infrapopliteal revascularisation—are unlikely to benefit from this protocol.

Why it matters

Potential benefit: If successful, adding CAP could speed ulcer healing after revascularisation, reduce local infection and pain, and lower the likelihood of prolonged wound care or limb loss.

How similar studies have performed: Preclinical work and small clinical reports suggest CAP has antimicrobial and pro-healing effects, but randomized controlled evidence in ischemic diabetic foot ulcers is limited.

Eligibility criteria

Inclusion Criteria:

* 1)Age between 18 and 80 years; diagnosed with type 1 or type 2 diabetes mellitus; with HbA1c ≤10%;
* 2)Presence of at least one chronic foot ulcer persisting for ≥3 weeks, with no signs of healing despite guideline-directed standard care; ulcer classified as Wagner-Armstrong grade 1D or 2D;
* 3)Imaging-confirmed infrapopliteal arterial stenosis or occlusion, assessed by vascular ultrasound and/or computed tomography angiography (CTA); all patients must have undergone infrapopliteal balloon angioplasty, with successful target vessel revascularisation confirmed intraoperatively (≤30% residual stenosis);
* 4)Signed written informed consent prior to study participation.

Exclusion Criteria:

* 1)Concurrent use of negative pressure wound therapy (NPWT) or maggot debridement therapy;
* 2)Undergoing dialysis for end-stage renal disease;
* 3)Use of topical antibiotics with known biological activity on the wound;
* 4)Use of platelet-rich fibrin (PRF) for wound treatment;
* 5)Women of childbearing potential without effective contraception, or currently breastfeeding;
* 6)Presence of severe comorbidities involving other organ systems, with an estimated life expectancy of less than 6 months;
* 7)Participation in another clinical trial within the past 3 months, or currently enrolled in another clinical study;
* 8)Any condition deemed unsuitable for trial participation at the discretion of the investigators.

Where this trial is running

Anshan, Liaoning

• Ansteel Group General Hospital — Anshan, Liaoning, China (RECRUITING)

Study contacts

• Principal investigator: Lin Tao, MM — Shenyang Medical College
• Study coordinator: Yun-En Liu, MD

Conditions: Diabetic Foot Ulcers, Lower Extremity Arterial Occlusion, Cold Atmospheric Plasma, lower extremity arterial occlusion