Varicose Veins Leg, Great Saphenous Vein Insufficiency, Chronic Venous Insufficiency
Conditions
Keywords
Calcium Dobesilate, Radiofrequency Ablation, Venoactive Drug, Postoperative Pain, Quality of Life
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.
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.
Interventions
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.
Sponsors
Oguz Arslanturk
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Intervention model description
Patients will be randomized 1:1 to intervention (calcium dobesilate) or control (standard care) group.
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Postoperative Pain Score (VAS) | Postoperative day 7 | Pain intensity measured using Visual Analog Scale (VAS) ranging from 0 (no pain) to 10 (worst possible pain) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Postoperative Pain Score at Day 14 and Day 30 | Postoperative day 14 and day 30 | Pain intensity measured using Visual Analog Scale (VAS) ranging from 0 to 10 |
| Venous Clinical Severity Score (VCSS) | Baseline, day 30, and day 90 | Clinical assessment of venous disease severity using standardized VCSS scoring system (0-30 points) |
| Quality of Life (CIVIQ-20) | Baseline, day 14, day 30, and day 90 | Disease-specific quality of life measured using Chronic Venous Insufficiency Questionnaire (CIVIQ-20) |
| Ecchymosis Score | 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) |
| Time to Return to Normal Activities | Up to 30 days postoperatively | Number of days until patient returns to normal daily activities and work |
| Postoperative Paresthesia Incidence | 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) |
| Endovenous Heat-Induced Thrombosis (EHIT) Incidence | Postoperative day 7 | Presence and grade of thrombus extension into the deep venous system assessed by duplex ultrasound using Lawrence classification (Class 1-4) |
| Great Saphenous Vein Occlusion Rate | Postoperative day 30 and day 90 | Complete occlusion of treated great saphenous vein confirmed by duplex ultrasound (absence of flow and compressibility) |
Countries
Turkey (Türkiye)
Contacts
CONTACTOguz Arslanturk, MD
PRINCIPAL_INVESTIGATOROguz Arslanturk, MD
Zonguldak Bulent Ecevit University
Outcome results
None listed