Effect of foam sclerotherapy on healing and long-term recurrence in chronic venous leg ulcers.
S R Kulkarni, F J A Slim, L G Emerson...
https://pubmed.ncbi.nlm.nih.gov/22422794Actively Recruiting
Age: 80Years +
All Genders
ID07233616
Risks and Benefits of Radiofrequency Ablation for Chronic Venous Insufficiency (CEAP C3-C6) in Patients Aged 80 and Over: A Prospective Single-Arm Cohort Study
Led by Chengdu University of Traditional Chinese Medicine · Updated on 2025-11-18
50
Participants Needed
1
Research Sites
13 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the risks and benefits of radiofrequency ablation (RFA) for treating severe chronic venous insufficiency (CVI) in patients aged 80 years and older. This study focuses on a vulnerable and growing population with CVI classified as CEAP C3 to C6 and confirmed reflux in the great or small saphenous veins. The purpose is to gather detailed safety and outcome data specific to this high-risk age group to inform clinical decisions and treatment guidelines. All participants will undergo endovenous RFA using the ClosureFast™ system or an equivalent device. The treatment is delivered under local tumescent anesthesia with ultrasound guidance to ablate the target saphenous vein. After the procedure, compression bandaging and Class II compression stockings will be used. This is a single-arm, prospective cohort study enrolling 50 patients, with follow-up assessments at 1, 3, and 6 months after the procedure. Participants will be monitored through duplex ultrasonography to measure vein occlusion rates and will complete quality of life questionnaires such as the Aberdeen Varicose Vein Questionnaire (AVVQ) and the Venous Clinical Severity Score (VCSS). Safety outcomes including complications like deep vein thrombosis and skin burns will be tracked within 30 days. The main outcomes are evaluated at 6 months, and the study provides a comprehensive profile of both technical success and patient-reported improvements over half a year.
CONDITIONS
Brief Title
Risks and Benefits of Radiofrequency Ablation for Chronic Venous Insufficiency (CEAP C3-C6) in Patients Aged 80 and Over
Who Can Participate
Age: 80Years +
All Genders
Eligibility Criteria
You may qualify if you...
- Aged 80 years or older
- Symptomatic chronic venous insufficiency classified as CEAP C3 (venous edema), C4a (pigmentation or eczema), C4b (lipodermatosclerosis or atrophie blanche), C5 (healed venous ulcer), or C6 (active venous ulcer)
- Confirmed reflux in the great or small saphenous vein by color duplex ultrasound (reflux time > 0.5 seconds)
- Able to understand and provide written informed consent
You will not qualify if you...
- Non-ambulatory or bedridden status
- Acute superficial thrombophlebitis or deep vein thrombosis in the target limb
- Significant peripheral arterial disease with ankle-brachial index less than 0.8 in the target limb
- Uncorrectable coagulation disorders
- Known severe allergy to local anesthetics or relevant device materials
- Severe cognitive impairment or psychiatric illness preventing understanding or follow-up
- Life expectancy less than one year due to other serious conditions
- Any other condition deemed unsuitable by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Implementation
Duration - Single procedure with post-treatment care
Participants undergo endovenous radiofrequency ablation under local anesthesia to treat chronic venous insufficiency. Compression bandaging is applied post-procedure and Class II compression stockings are prescribed.
1 procedure visit and follow-up care as needed
Trial Site Locations
Total: 1 location
1
Hospital of Chengdu University of Traditional Chinese Medicine
Chengdu, Sichuan, China, 610072
Actively Recruiting
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Research Team
C
Chunshui He Doctor
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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Published Research Related To This Trial
Catheter-directed foam sclerotherapy for chronic venous leg ulcers.
Caroline Williamsson, Peter Danielsson, Lennart Smith
https://pubmed.ncbi.nlm.nih.gov/24072751Ten-year outcomes of a randomized clinical trial of endothermal ablation versus conventional surgery for great saphenous varicose veins.
Abduraheem H Mohamed, Annabel Howitt, Shivani Rae...
https://pubmed.ncbi.nlm.nih.gov/39162334