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NCT07198061
Efficacy and Safety of Cold Atmospheric Plasma Combined With Endovascular Intervention for Diabetic Foot Ulcers With Lower Extremity Arterial Occlusion
NA trial testing Cold Atmospheric Plasma (CAP) in Diabetic Foot Ulcers (DFU) in 40 participants. Currently enrolling.
20 March 2026
Quick facts
| Lead sponsor | Shenyang Medical College |
|---|---|
| Phase | NA |
| Status | Recruiting now |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | double |
| Primary purpose | treatment |
| Enrollment | 40 |
| Start date | 9 October 2025 |
| Primary completion | 20 March 2026 |
| Estimated completion | 30 March 2026 |
| Sites | 1 location across China |
Drugs / interventions tested
- Cold Atmospheric Plasma (CAP)
- Sham CAP Therapy
- Infrapopliteal Endovascular Revascularisation
- Guideline-Based Standard DFU Care
Conditions studied
- Diabetic Foot Ulcers (DFU) — all drugs for Diabetic Foot Ulcers (DFU) →
- Lower Extremity Arterial Occlusion — all drugs for Lower Extremity Arterial Occlusion →
Sponsor
Shenyang Medical College
Who can join
Adults 18 to 80, any sex, with Diabetic Foot Ulcers (DFU) or Lower Extremity Arterial Occlusion. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT07198061
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Diabetic Foot Ulcers (DFU)
Currently open trials in the same condition.
- NCT07073040 — Efficacy and Safety of Cold Atmospheric Plasma Combined With Endovascular Intervention in Patients With Diabetic Foot Ul · NA · recruiting
- NCT06977048 — Effects of an Animated Mobile Application on Diabetic Foot Ulcer Management · NA · active not recruiting
Other Shenyang Medical College trials
Trials by the same sponsor.
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- NCT07233278 — High-Intensity, Low-Frequency Periodic rTMS Over the Right Dorsolateral Prefrontal Cortex on Cardiac Autonomic Regulatio · NA · not yet recruiting
- NCT07238920 — Closed-Loop Neurofeedback Targeting the Right Dorsolateral Prefrontal Cortex for Cardiac Autonomic Modulation in Coronar · NA · not yet recruiting
- NCT07056673 — Cold Atmospheric Plasma for Moderate-to-severe Acne Vulgaris Study · NA · recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT07198061 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Shenyang Medical College
- Last refreshed: 18 November 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT07198061.
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