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NCT Number: NCT07390097

Calcium Dobesilate After Radiofrequency Ablation for Varicose Veins

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.

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Key information

Conditions

Varicose Veins Leg Chronic Venous Insufficiency Great Saphenous Vein Insufficiency Neurologic Manifestations Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Zonguldak Bulent Ecevit University Hospital, Department of Cardiovascular Surgery

Kozlu, Zonguldak Province, 67600, Turkey (Türkiye)

Location contact

Oguz Arslanturk, MD

CONTACT

[email protected]

+905395613887

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Postoperative Pain Score (VAS)

    Time frame: Postoperative day 7

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

Secondary outcomes

  1. Postoperative Pain Score at Day 14 and Day 30

    Time frame: Postoperative day 14 and day 30

    Pain intensity measured using Visual Analog Scale (VAS) ranging from 0 to 10

  2. Venous Clinical Severity Score (VCSS)

    Time frame: Baseline, day 30, and day 90

    Clinical assessment of venous disease severity using standardized VCSS scoring system (0-30 points)

  3. Quality of Life (CIVIQ-20)

    Time frame: Baseline, day 14, day 30, and day 90

    Disease-specific quality of life measured using Chronic Venous Insufficiency Questionnaire (CIVIQ-20)

  4. Ecchymosis Score

    Time frame: Postoperative day 1, day 7, and day 14

    Postoperative bruising assessed using a 5-point scale (0=none, 1=<5cm, 2=5-10cm, 3=10-20cm, 4=>20cm)

  5. Time to Return to Normal Activities

    Time frame: Up to 30 days postoperatively

    Number of days until patient returns to normal daily activities and work

  6. Postoperative Paresthesia Incidence

    Time frame: Postoperative day 7, day 30, and day 90

    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)

  7. Endovenous Heat-Induced Thrombosis (EHIT) Incidence

    Time frame: Postoperative day 7

    Presence and grade of thrombus extension into the deep venous system assessed by duplex ultrasound using Lawrence classification (Class 1-4)

  8. Great Saphenous Vein Occlusion Rate

    Time frame: Postoperative day 30 and day 90

    Complete occlusion of treated great saphenous vein confirmed by duplex ultrasound (absence of flow and compressibility)

Study contacts

Contact information is provided by the study sponsor or research team.

Oguz Arslanturk, MD

CONTACT

[email protected]

+905395613887

Sponsors and collaborators

Lead sponsor

Oguz Arslanturk

Other

Registry information

Official study 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

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Feb 5, 2026
Registry last updated
Feb 5, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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