Calcium Dobesilate After Radiofrequency Ablation for Varicose Veins

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Chronic Venous Insufficiency; Varicose Veins Leg; Great Saphenous Vein Insufficiency
• Intervention / Treatment: Drug: calcium dobesilate

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.

• Study Type: Interventional
• Enrollment (Estimated): 250
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Oguz Arslanturk, MD; Phone Number: +905395613887; Email: oguz.arslanturk@beun.edu.tr

Study Locations

• Turkey (Türkiye)
  • Zonguldak Province
    • Kozlu, Zonguldak Province, Turkey (Türkiye), 67600
      • Zonguldak Bulent Ecevit University Hospital, Department of Cardiovascular Surgery
      • Contact: Oguz Arslanturk, MD; Phone Number: +905395613887; Email: oguz.arslanturk@beun.edu.tr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control Group; Participants receive standard care only (RFA plus compression stockings) without calcium dobesilate.
Experimental: Calcium Dobesilate Group; 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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Postoperative Pain Score at Day 14 and Day 30	Pain intensity measured using Visual Analog Scale (VAS) ranging from 0 to 10	Postoperative day 14 and day 30
Venous Clinical Severity Score (VCSS)	Clinical assessment of venous disease severity using standardized VCSS scoring system (0-30 points)	Baseline, day 30, and day 90
Quality of Life (CIVIQ-20)	Disease-specific quality of life measured using Chronic Venous Insufficiency Questionnaire (CIVIQ-20)	Baseline, day 14, day 30, and day 90
Ecchymosis Score	Postoperative bruising assessed using a 5-point scale (0=none, 1=<5cm, 2=5-10cm, 3=10-20cm, 4=>20cm)	Postoperative day 1, day 7, and day 14
Time to Return to Normal Activities	Number of days until patient returns to normal daily activities and work	Up to 30 days postoperatively
Postoperative Paresthesia Incidence	Presence and severity of numbness, tingling, or sensory changes along the treated vein assessed using a 4-point scale (0=none, 1=mild, 2=moderate, 3=severe)	Postoperative day 7, day 30, and day 90
Endovenous Heat-Induced Thrombosis (EHIT) Incidence	Presence and grade of thrombus extension into the deep venous system assessed by duplex ultrasound using Lawrence classification (Class 1-4)	Postoperative day 7
Great Saphenous Vein Occlusion Rate	Complete occlusion of treated great saphenous vein confirmed by duplex ultrasound (absence of flow and compressibility)	Postoperative day 30 and day 90

Collaborators and Investigators

• Sponsor: Oguz Arslanturk
• Investigators: Principal Investigator: Oguz Arslanturk, MD, Zonguldak Bülent Ecevit University

Study record dates

Study Major Dates

• Study Start (Estimated): February 28, 2026
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): November 1, 2026

Study Registration Dates

• First Submitted: January 28, 2026
• First Submitted That Met QC Criteria: January 28, 2026
• First Posted (Actual): February 5, 2026

Study Record Updates

• Last Update Posted (Actual): February 5, 2026
• Last Update Submitted That Met QC Criteria: January 28, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: Postoperative Pain; Quality of Life; Radiofrequency Ablation; Calcium Dobesilate; Venoactive Drug
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Pain, Postoperative; Sulfur Compounds; Organic Chemicals; Hydrocarbons; Hydrocarbons, Cyclic; Hydrocarbons, Aromatic; Benzene Derivatives; Sulfonic Acids; Sulfur Acids; Benzenesulfonates; Arylsulfonates; Arylsulfonic Acids; Calcium Dobesilate
• Other Study ID Numbers: BEUN-CVS-2026-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Individual participant data will not be shared due to local data protection regulations and limited resources for data anonymization and management.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No