Calcium Dobesilate After Radiofrequency Ablation for Varicose Veins
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: calcium dobesilate.
- Who it may be relevant to
- Registry conditions: Varicose Veins Leg, Great Saphenous Vein Insufficiency, Chronic Venous Insufficiency. Basic parameters: 18 years — 70 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Turkey (Türkiye)
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Effect of Perioperative Calcium Dobesilate on Postprocedural Pain, Symptom Relief, and Quality of Life After Radiofrequency Ablation for Great Saphenous Vein Insufficiency: A Randomized Controlled Trial
Overview
This study evaluates whether calcium dobesilate, a venoactive drug, improves recovery after radiofrequency ablation (RFA) for varicose veins. Patients with great saphenous vein insufficiency undergoing RFA will be randomly assigned to receive either calcium dobesilate (500 mg twice daily) or standard care alone. The treatment starts 7 days before the procedure and continues for 30 days after. The primary outcome is postoperative pain at day 7. Secondary outcomes include pain at days 14 and 30, quality of life, ecchymosis, and return to daily activities.
Detailed description
Radiofrequency ablation (RFA) is a minimally invasive treatment for great saphenous vein insufficiency. Although effective, patients may experience postprocedural pain, ecchymosis, and discomfort during recovery. Venoactive drugs have been shown to reduce symptoms in chronic venous disease and may improve recovery after venous procedures.
Calcium dobesilate is a venoactive agent that reduces capillary permeability, inhibits platelet aggregation, and has anti-inflammatory properties. It is approved for chronic venous insufficiency treatment in many countries including Turkey.
This prospective, randomized, open-label, controlled trial will investigate whether perioperative calcium dobesilate administration improves clinical outcomes after RFA. Approximately 100 patients will be enrolled and randomized 1:1 to either:
* Intervention group: Calcium dobesilate 500 mg twice daily starting 7 days before RFA and continuing for 30 days postoperatively, plus standard care * Control group: Standard care alone (RFA plus compression stockings)
All patients will undergo standardized RFA procedure under tumescent anesthesia. Assessments will be performed at baseline, and postoperative days 1, 7, 14, 30, and 90. Primary endpoint is pain score (VAS) at day 7. Secondary endpoints include VCSS, CIVIQ-20 quality of life score, ecchymosis score, analgesic use, and time to return to normal activities.
Interventions
- Drug calcium dobesilate
Calcium dobesilate 500 mg oral tablet, twice daily (morning and evening), starting 7 days before radiofrequency ablation and continuing for 30 days postoperatively. Total treatment duration is 37 days.
Primary outcome measures
- Postoperative Pain Score (VAS) [Time frame: Postoperative day 7]
Secondary outcome measures (8)
- Postoperative Pain Score at Day 14 and Day 30 [Time frame: Postoperative day 14 and day 30]
- Venous Clinical Severity Score (VCSS) [Time frame: Baseline, day 30, and day 90]
- Quality of Life (CIVIQ-20) [Time frame: Baseline, day 14, day 30, and day 90]
- Ecchymosis Score [Time frame: Postoperative day 1, day 7, and day 14]
- Time to Return to Normal Activities [Time frame: Up to 30 days postoperatively]
- Postoperative Paresthesia Incidence [Time frame: Postoperative day 7, day 30, and day 90]
- Endovenous Heat-Induced Thrombosis (EHIT) Incidence [Time frame: Postoperative day 7]
- Great Saphenous Vein Occlusion Rate [Time frame: Postoperative day 30 and day 90]
Eligibility criteria
Inclusion criteria
- Age 18-70 years
- Symptomatic primary varicose veins (CEAP classification C2-C4)
- Great saphenous vein insufficiency confirmed by duplex ultrasound (reflux >0.5 seconds)
- Great saphenous vein diameter 5-12 mm
- Scheduled for radiofrequency ablation
- Able to provide written informed consent
Exclusion criteria
- History of deep vein thrombosis
- Peripheral arterial disease (ABI <0.9)
- Active venous ulcer (CEAP C6)
- Pregnancy or breastfeeding
- Severe renal or hepatic insufficiency
- Known allergy to calcium dobesilate
- Use of venoactive drugs within the past 4 weeks
- Current anticoagulant therapy
- Previous venous intervention on the same limb
- Bilateral disease requiring simultaneous treatment
- Inability to comply with follow-up schedule
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Supportive care
Study locations
Turkey (Türkiye) · 1 center
- Zonguldak Bulent Ecevit University Hospital, Department of Cardiovascular Surgery — Kozlu
Identifiers
NCT: NCT07390097 · BEUN-CVS-2026-001