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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 for Diabetic Foot Ulcers With Lower Extremity Arterial Occlusion
ClinicalTrials.gov ID: NCT07198061
What this study is testing
- What it's testing
- 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.
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance.
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
- 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...
- 3)Imaging-confirmed infrapopliteal arterial stenosis or occlusion, assessed by vascular ultrasound and/or computed tomography angiography (CTA); all...
- 4)Signed written informed consent prior to study participation.
You likely can't join if
- 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;
See the full eligibility 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...
- 4)Signed written informed consent prior to study participation.
- 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.
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.