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

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Ansteel Group General Hospital
  Anshan, Liaoning, China Recruiting

Study contacts

• Principal investigator: Lin Tao, MM — Shenyang Medical College
• Study coordinator: Yun-En Liu, MD
• Email: lye9901@163.com
• Phone: 86-24-62215130

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.