Cold plasma could save limbs in diabetic patients
NCT ID NCT07073040
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests whether adding cold atmospheric plasma to standard artery-opening treatment helps heal diabetic foot ulcers faster. About 86 adults with diabetes and blocked leg arteries will receive either real or fake plasma sessions over two weeks. The goal is to see if the plasma reduces wound size and prevents infection.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- cold atmospheric plasma (device)
- What this could lead to
- If it works, this could provide a new, safe way to help heal stubborn diabetic foot ulcers and lower the risk of amputation.
- What could go wrong
- This is a small, early-stage trial with only 86 participants. The added benefit of plasma over standard care may be modest, and the device requires multiple sessions.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 86 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jul 2025
- Expected to finish
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May 2026
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 80 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Aged 18-80 years, with a diagnosis of type 1 or type 2 diabetes and diabetic foot ulcer; glycated hemoglobin (HbA1c) ≤ 10%. * Presence of at least one chronic foot ulcer persisting for at least three weeks, with no signs of healing after standard-of-care treatment based on current clinical guidelines. The ulcer must be classified as Wagner-Armstrong grade 1D or 2D (Wagner: superficial ulcer \[grade 1\] or ulcer extending to tendon \[grade 2\]; Armstrong: presence of both ischaemia and infection \[stage D\]). * Documented infrapopliteal arterial stenosis or occlusion by vascular ultrasound and/or CT angiography (CTA), meeting indications for revascularization. All enrolled patients must have received successful infrapopliteal balloon angioplasty, with intraoperative angiography confirming target artery patency. * Provision of written informed consent. Exclusion Criteria: * Concurrent treatment of the wound with local vacuum therapy or maggot therapy. * Undergoing dialysis. * Use of local active antibiotics. * Treatment with platelet-rich fibrin. * Women of childbearing potential without effective contraception, or women who are actively breastfeeding. * Presence of other severe organ dysfunction, with an expected survival of less than six months. * Participation in another clinical trial within the past three months or currently enrolled in another clinical trial.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Ansteel General Hospital
RECRUITINGAnshan, Liaoning, China
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