Ignite Creation Date:
2025-12-24 @ 12:37 PM
Ignite Modification Date:
2025-12-28 @ 2:19 AM
Study NCT ID:
NCT07198061
Status:
RECRUITING
Last Update Posted:
2025-11-18
First Post:
2025-09-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy and Safety of Cold Atmospheric Plasma Combined With Endovascular Intervention for Diabetic Foot Ulcers With Lower Extremity Arterial Occlusion
Sponsor:
Shenyang Medical College
Organization:
Study Overview
Official Title:
Efficacy and Safety of Cold Atmospheric Plasma Combined With Endovascular Intervention for Diabetic Foot Ulcers With Lower Extremity Arterial Occlusion: A Randomized, Double-Blind, Placebo-Controlled Trial
Status:
RECRUITING
Status Verified Date:
2025-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
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
Detailed Description:
Diabetic foot ulcers (DFUs) complicated by lower extremity arterial occlusion are difficult to heal, even after successful endovascular revascularisation, due to persistent microcirculatory impairment and chronic inflammation. Cold atmospheric plasma (CAP) has shown promising effects in promoting wound healing through antimicrobial activity, angiogenesis induction, and modulation of inflammatory responses. However, its efficacy and safety in the clinical treatment of DFUs remain to be validated in randomized controlled trials.
This prospective, randomized, placebo-controlled, single-center clinical trial aims to assess the efficacy and safety of CAP therapy, delivered as CAP-activated gas, in patients with DFUs who have undergone successful infrapopliteal balloon angioplasty. Participants will receive either active or sham CAP therapy once daily for 10 days, in addition to standard DFU care. The primary endpoint is the percentage reduction in ulcer area at Week 4. Secondary outcomes include time to early healing response, pain scores, quality of life, and local adverse events.
The results of this study are expected to provide clinical evidence supporting the use of CAP as an adjunctive therapy in ischemic diabetic foot wound management.
This prospective, randomized, placebo-controlled, single-center clinical trial aims to assess the efficacy and safety of CAP therapy, delivered as CAP-activated gas, in patients with DFUs who have undergone successful infrapopliteal balloon angioplasty. Participants will receive either active or sham CAP therapy once daily for 10 days, in addition to standard DFU care. The primary endpoint is the percentage reduction in ulcer area at Week 4. Secondary outcomes include time to early healing response, pain scores, quality of life, and local adverse events.
The results of this study are expected to provide clinical evidence supporting the use of CAP as an adjunctive therapy in ischemic diabetic foot wound management.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: