Health TrialsbyHealthPanel

Calcium Dobesilate After Radiofrequency Ablation for Varicose Veins

ConditionsVaricose Veins LegGreat Saphenous Vein InsufficiencyChronic Venous Insufficiency
Trial statusNot yet recruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18-70
SponsorOguz Arslanturk

About this 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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

History of deep vein thrombosis

Peripheral arterial disease (ABI <0.9)

Active venous ulcer (CEAP C6)

Pregnancy or breastfeeding

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

Treatment groups

250 Participants
are divided into 2 treatment groups
Group A: Control GroupNo intervention 0 interventions
Group B: Calcium Dobesilate GroupExperimental treatment 1 intervention

Trial outcomes

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)

Time frame
Postoperative day 7

Secondary outcomes

1

Postoperative Pain Score at Day 14 and Day 30

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

Time frame
Postoperative day 14 and day 30
2

Venous Clinical Severity Score (VCSS)

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

Time frame
Baseline, day 30, and day 90
3

Quality of Life (CIVIQ-20)

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

Time frame
Baseline, day 14, day 30, and day 90
4

Ecchymosis Score

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

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Oguz Arslanturk

Lead sponsor

Bulent Ecevit University

Sponsor institution

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: