RECRUITINGINTERVENTIONAL

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

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

About This Trial

The goal of this clinical trial is to evaluate whether cold atmospheric plasma (CAP) combined with endovascular intervention can accelerate wound healing and improve safety outcomes in patients aged 18 to 80 years with diabetic foot ulcers (DFUs) complicated by lower extremity arterial occlusion. The main questions it aims to answer are: 1. Does CAP treatment lead to a greater reduction in ulcer area by Week 4 compared to placebo?; 2. Is CAP therapy safe and well-tolerated in patients with DFUs after successful infrapopliteal revascularisation?; Researchers will compare CAP treatment plus standard care to sham CAP (placebo) plus standard care to see if CAP improves wound healing more effectively and reduces adverse local symptoms. Participants will: 1. Receive either active CAP therapy or sham CAP therapy once daily for 10 days following endovascular revascularisation 2. Undergo daily wound assessments for ulcer area, signs of infection, and pain scores 3. Complete quality-of-life questionnaires (EQ-5D and SF-12) at baseline and Week 4 4. Be followed through Week 4 to assess efficacy and safety endpoints

Who May Be Eligible (Plain English)

Who May Qualify: - 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 willing to sign a consent form prior to study participation. Who Should NOT Join This Trial: - 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. Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language

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.

Treatments Being Tested

DEVICE

Cold Atmospheric Plasma (CAP)

CAP-activated gas treatment developed by Xi'an Jiaotong University (Chinese patent No. ZL202110209052.X); administered once daily for 10 days, 25 minutes per session.

DEVICE

Sham CAP Therapy

Identical equipment without plasma activation; simulates treatment environment (sound, airflow) for participant blinding.

PROCEDURE

Infrapopliteal Endovascular Revascularisation

Balloon angioplasty is performed on infrapopliteal arteries with significant stenosis or occlusion. Technical success is defined as \<30% residual stenosis, confirmed intraoperatively by digital subtraction angiography (DSA). Only patients with successful revascularisation are eligible for randomisation.

OTHER

Guideline-Based Standard DFU Care

All participants will receive diabetic foot ulcer (DFU) care according to current international and Chinese clinical guidelines

Locations (1)

Ansteel Group General Hospital

Anshan, Liaoning, China