Calcium Dobesilate After Radiofrequency Ablation for Varicose Veins

NCT07390097 | Not Yet Recruiting Phase 4

• 1 other identifier: BEUN-CVS-2026-001
• Study Type: interventional
• Target: 250
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

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

Keywords

Calcium Dobesilate; Radiofrequency Ablation; Venoactive Drug; Postoperative Pain; Quality of Life

Outcome Measures

Primary Outcomes (1)

• Postoperative Pain Score (VAS)

  Pain intensity measured using Visual Analog Scale (VAS) ranging from 0 (no pain) to 10 (worst possible pain)

  Postoperative day 7

Secondary Outcomes (8)

• Postoperative Pain Score at Day 14 and Day 30

  Postoperative day 14 and day 30

• Venous Clinical Severity Score (VCSS)

  Baseline, day 30, and day 90

• Quality of Life (CIVIQ-20)

  Baseline, day 14, day 30, and day 90

• Ecchymosis Score

  Postoperative day 1, day 7, and day 14

• Time to Return to Normal Activities

  Up to 30 days postoperatively

Study Arms (2)

Control Group

NO INTERVENTION

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

Calcium Dobesilate Group

EXPERIMENTAL

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).

Drug: calcium dobesilate

Interventions

calcium dobesilate DRUG

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.

Calcium Dobesilate Group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Oguz Arslanturk: lead

Study Sites (1)

Zonguldak Bulent Ecevit University Hospital, Department of Cardiovascular Surgery

Kozlu, Zonguldak Province, 67600, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Calcium Dobesilate

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Benzenesulfonates; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Arylsulfonates; Arylsulfonic Acids; Sulfonic Acids; Sulfur Acids; Sulfur Compounds

Study Officials

• Oguz Arslanturk, MD

  Zonguldak Bulent Ecevit University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Oguz Arslanturk, MD

CONTACT

+905395613887; oguz.arslanturk@beun.edu.tr

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Professor, Department of Cardiovascular Surgery

Model Details: Patients will be randomized 1:1 to intervention (calcium dobesilate) or control (standard care) group.

Study Record Dates

• First Submitted: January 28, 2026
• First Posted: February 5, 2026
• Study Start: February 28, 2026
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): November 1, 2026
• Last Updated: February 5, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)