Calcium Dobesilate After Radiofrequency Ablation for Varicose Veins

Oguz Arslanturk

Status and phase: Begins enrollment this month; Phase 4

Conditions: Varicose Veins Leg; Chronic Venous Insufficiency; Great Saphenous Vein Insufficiency

Treatments: Drug: calcium dobesilate

Study type: Interventional

Funder types: Other

Identifiers

NCT07390097

BEUN-CVS-2026-001

Details and patient eligibility

About

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.

Full 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.

Enrollment: 250 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

250 participants in 2 patient groups

Control Group

No Intervention group

Description:

Participants receive standard care only (RFA plus compression stockings) without calcium dobesilate.

Calcium Dobesilate Group

Experimental group

Description:

Participants receive calcium dobesilate 500 mg orally twice daily, starting 7 days before RFA and continuing for 30 days after the procedure, in addition to standard care (RFA plus compression stockings).

Treatment:

Drug: calcium dobesilate