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

Browse trials for

• Diabetic Foot 1,053

Keywords

• Cold Atmospheric Plasma
• Diabetic Foot Ulcers
• lower extremity arterial occlusion

Study arms

• Experimental
  Cold Atmospheric Plasma (CAP) Group

  Participants with diabetic foot ulcers (DFUs) and infrapopliteal arterial occlusion who receive CAP therapy once daily for 10 days following successful endovascular intervention.

  Device: Cold Atmospheric Plasma (CAP) · Procedure: Infrapopliteal Endovascular Revascularisation · Other: Guideline-Based Standard DFU Care

• Placebo comparator
  Sham CAP (Placebo) Group

  Participants with DFUs and infrapopliteal arterial occlusion who receive sham CAP therapy with an identical-looking device that does not produce active plasma.

  Device: Sham CAP Therapy · Procedure: Infrapopliteal Endovascular Revascularisation · Other: Guideline-Based Standard DFU Care

Interventions

• DeviceCold 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.

• DeviceSham CAP Therapy

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

• ProcedureInfrapopliteal 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.

• OtherGuideline-Based Standard DFU Care

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

Primary outcomes

1. Change in ulcer area (cm²)

   Ulcer area will be measured at baseline, daily from Day 1 to Day 10, and at Week 4 post-randomisation. Measurements are obtained from calibrated wound photographs and analysed using ImageJ software. Primary endpoint will be analysed using a linear mixed-effects model to evaluate differences between groups over time.

   Time frame: assessed at baseline, Day 1 to Day 10 post-randomisation, and at Week 4

Secondary outcomes

1. Time to 10% reduction in ulcer area

   The time (in days) from baseline to the first documentation of ≥10% reduction in ulcer surface area compared to baseline, as measured by calibrated wound photography analysed using ImageJ software. Ulcer size is measured daily from Day 1 to Day 10 and at Week 4.

   Time frame: From baseline through Day 10 and Week 4 post-randomisation

2. Mean change in pain score measured by Visual Analogue Scale (VAS)

   Pain severity will be assessed using the 10-point Visual Analogue Scale (VAS), where 0 indicates no pain and 10 indicates the worst pain imaginable. Measurements will be taken at baseline, daily from Day 1 to Day 10, and at Week 4 post-randomisation. Change in VAS score over time will be compared between groups.

   Time frame: Baseline; daily from Day 1 to Day 10; and at Week 4 post-randomisation

3. Change in quality of life (EQ-5D)

   Health-related quality of life will be assessed using the EuroQol 5-Dimension 5-Level questionnaire (EQ-5D-5L) at baseline and Week 4 post-randomisation. The EQ-5D-5L descriptive system evaluates five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression, each scored on a 5-point ordinal scale (1 = no problems, 5 = extreme problems).

   Time frame: Baseline and Week 4 post-randomisation

4. Change in quality of life (SF-12)

   Quality of life will be assessed using the 12-Item Short Form Health Survey (SF-12) at baseline and Week 4 post-randomisation. The SF-12 is a validated instrument designed to evaluate health-related quality of life across physical and mental health domains. It yields two composite summary scores: the Physical Component Summary (PCS) and the Mental Component Summary (MCS). Each component score typically ranges from 0 to 100, with higher scores indicating better health status.

   Time frame: Baseline and Week 4 post-randomisation

Other outcomes

1. Incidence of skin irritation

   The presence or absence of skin irritation at the treatment site will be recorded by trained clinical staff during each treatment session (Day 1-10) and at Week 4. Skin irritation includes erythema, rash, itching, or other subjective symptoms reported by the participant or observed by the investigator.

   Time frame: Daily from baseline to Day 10 and at Week 4 post-randomisation

2. Incidence of local bleeding

   Bleeding at the wound or treatment site will be assessed by visual inspection and clinical documentation. Events are recorded as present or absent at each time point, and severity (mild, moderate, severe) will be noted if applicable.

   Time frame: Daily from baseline to Day 10 and at Week 4 post-randomisation

3. Incidence of local burning sensation

   Participants will be asked to report any burning sensation at the treatment site during or after CAP exposure. Events will be recorded as present or absent, and graded based on severity. This outcome will help assess the tolerability of CAP treatment.

   Time frame: Daily from baseline to Day 10 and at Week 4 post-randomisation

Individual participant data

Plan to share: Yes

Supporting information: Study protocol