Comparing two treatments for incompetent perforating veins
Percutaneous Electrocoagulation Versus Sclerosing Foam for Patients With Incompetent Perforating Veins : A Multi-center Prospective Randomized Controlled Trial
This study is testing which treatment, either electrocoagulation or sclerotherapy, works better for people with incompetent perforating veins that cause stubborn venous ulcers.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 84 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | Second Affiliated Hospital, School of Medicine, Zhejiang University Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 5 sites (Hefei, Anhui and 4 other locations) |
| Trial ID | NCT04686097 on ClinicalTrials.gov |
What this trial studies
This study aims to compare the effectiveness of percutaneous electrocoagulation and sclerotherapy in treating incompetent perforating veins, which are a significant cause of persistent venous ulcers. It is a multicenter, randomized controlled trial involving 84 patients who will be assigned to either the electrocoagulation group or the sclerotherapy group. The primary outcome will be the occlusion rate of the veins after 12 months, while secondary outcomes will include quality of life assessments and rates of complications. The study seeks to provide evidence on the best treatment approach for this condition.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 to 80 with incompetent perforating veins classified as C4b to C6 according to the CEAP classification.
Not a fit: Patients with a history of deep vein thrombosis, pulmonary embolism, or other significant vascular conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved treatment options for patients suffering from incompetent perforating veins and associated venous ulcers.
How similar studies have performed: While there are no comparative studies of these specific treatment modalities, the approaches have shown promise individually in treating venous conditions.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: (1) outward flow of less than 500 ms duration, with a diameter of \>3.5 mm; (2) According to the CEAP classification method specified by the International Venous Federation, patients with C4b\~C6 grades are included. Exclusion Criteria: (1)age \< 18 years or age \> 80 years; (2)with malignant tumors and life expectancy \< 1 year; (3)with past or current history of deep vein thrombosis and/or pulmonary embolism in the lower extremities; (4)with congenital venous malformations (K-T syndrome, arteriovenous fistula and etc.; (5)inability to walk, long-term braking, restrictive bed rest; severe ischemia of lower extremities or diagnosed severity of peripheral artery occlusive disease; (6)according to the researcher's judgment, it is not suitable for foam hardener and puncture coagulation treatment; (7)allergic to the drugs and equipment materials involved in the research; (8)with inferior vena cava and/or iliac vein stenosis or occlusion; (9)with autoimmune disease, receiving chemotherapy, hormone therapy or immunomodulatory treatment; (10)other underlying severe diseases; women who are pregnant, breastfeeding or have pregnancy plans during the study period; (11)the patient cannot cooperate to complete the inspection and follow-up required by the study.
Where this trial is running
Hefei, Anhui and 4 other locations
- Anhui Provincial Hospital — Hefei, Anhui, China (Suspended)
- Yantai Yuhuangding Hospital — Yantai, Shandong, China (Suspended)
- Zhongshan Hospital affiliated to Fudan University — Shanghai, Shanghai, China (Suspended)
- Sir Run Run Shaw Hospital — Hangzhou, Zhejiang, China (Suspended)
- The second affiliated hospital of zhejiang university school of medicine — Hangzhou, Zhejiang, China (Recruiting)
Study contacts
- Principal investigator: Zhen jie Liu, MD,PhD — Second Affiliated Hospital, School of Medicine, Zhejiang University
- Study coordinator: Zhen jie Liu
- Email: lawson4001@zju.edu.cn
- Phone: 86-0571-87913706
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.