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Tests treatment safety and results for Diabetic Foot Ulcers (DFU)
Official title Efficacy and Safety of Cold Atmospheric Plasma Combined With Endovascular Intervention in Patients With Diabetic Foot Ulcers and Lower Extremity Arterial Occlusion
ClinicalTrials.gov ID: NCT07073040
What this study is testing
- What it's testing
- Critical limb ischemia is the end-stage manifestation of peripheral arterial disease (PAD), frequently presenting as ischemic rest pain, ulceration, or gangrene. Diabetes mellitus is a major risk factor for lower extremity arterial occlusion, with infrapopliteal arteries most commonly affected.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 80
You may be able to join if
- 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...
- Documented infrapopliteal arterial stenosis or occlusion by vascular ultrasound and/or CT angiography (CTA), meeting indications for...
- Provision of written informed consent.
You likely can't join if
- 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.
See the full eligibility 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...
- 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...
- Provision of written informed consent.
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Anshan, Liaoning, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 80 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Anshan, Liaoning, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.