Varicose Veins LegPhase 4NCT07390097
Calcium Dobesilate After Radiofrequency Ablation for Varicose Veins
A Phase 4 study testing calcium dobesilate in people with Varicose Veins Leg and Great Saphenous Vein Insufficiency, run by Oguz Arslanturk at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Varicose Veins Leg, Great Saphenous Vein Insufficiency, Chronic Venous Insufficiency
- What is being tested?
- calcium dobesilate
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 250 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 28 Feb 2026to Nov 2026
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 11Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site
Zonguldak Bulent Ecevit University Hospital, Department of Cardiovascular Surgery
Kozlu, Zonguldak Province, 67600
Oguz Arslanturk, MD, +905395613887, oguz.arslanturk@beun.edu.tr
About this study
Official 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
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.
Read the 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.
- Being tested
- calcium dobesilate
- Keywords
- Calcium Dobesilate, Radiofrequency Ablation, Venoactive Drug, Postoperative Pain, Quality of Life
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
calcium dobesilateDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: Drug: calcium dobesilate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative Pain Score (VAS)
Pain intensity measured using Visual Analog Scale (VAS) ranging from 0 (no pain) to 10 (worst possible pain)
Measured: Postoperative day 7
Secondary outcomes (8)
Postoperative Pain Score at Day 14 and Day 30
Pain intensity measured using Visual Analog Scale (VAS) ranging from 0 to 10
Measured: 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)
Measured: Baseline, day 30, and day 90
Quality of Life (CIVIQ-20)
Disease-specific quality of life measured using Chronic Venous Insufficiency Questionnaire (CIVIQ-20)
Measured: 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)
Measured: 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
Measured: 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)
Measured: 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)
Measured: Postoperative day 7
Great Saphenous Vein Occlusion Rate
Complete occlusion of treated great saphenous vein confirmed by duplex ultrasound (absence of flow and compressibility)
Measured: Postoperative day 30 and day 90
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2026
- Study start28 Feb 2026 (estimated)
- Primary completionAug 2026 (estimated)
- Study completionNov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Varicose Veins LegStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Patients will be randomized 1:1 to intervention (calcium dobesilate) or control (standard care) group.
- Masking
- None (open label)
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Oguz Arslanturk
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Oguz Arslanturk, Bulent Ecevit University
- Investigators
- Oguz Arslanturk, MD, Principal investigator, Zonguldak Bulent Ecevit University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07390097
- Sponsor's protocol ID
- BEUN-CVS-2026-001
- Status last verified
- Jan 2026
- First submitted
- 28 Jan 2026
- Last updated
- 5 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared due to local data protection regulations and limited resources for data anonymization and management.
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT07390097
- Acronym / sponsor ID
- BEUN-CVS-2026-001
- Keywords
- Calcium Dobesilate, Radiofrequency Ablation, Venoactive Drug, Postoperative Pain, Quality of Life
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- Oguz ArslanturkUniversity, hospital or other
- Study start
- 28 Feb 2026 (estimated)
- Primary completion
- Aug 2026 (estimated)
- Study completion
- Nov 2026 (estimated)
- First posted
- 5 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Patients will be randomized 1:1 to intervention (calcium dobesilate) or control (standard care) group.
| Arm | Type | Receives |
|---|---|---|
| Control Group | No intervention | –Participants receive standard care only (RFA plus compression stockings) without calcium dobesilate. |
| Calcium Dobesilate Group | Experimental | Drug: calcium dobesilateParticipants 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). |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (11 listed)
- History of deep vein thrombosis
- Peripheral arterial disease (ABI <0.9)
- Active venous ulcer (CEAP C6)
- Pregnancy or breastfeeding
- Severe renal or hepatic insufficiency
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| calcium dobesilateCalcium 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. | Drug | Calcium Dobesilate Group |
Primary outcome
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)
8 secondary outcomes
Postoperative Pain Score at Day 14 and Day 30
Time frame: Postoperative day 14 and day 30
Venous Clinical Severity Score (VCSS)
Time frame: Baseline, day 30, and day 90
Quality of Life (CIVIQ-20)
Time frame: Baseline, day 14, day 30, and day 90
Ecchymosis Score
Time frame: Postoperative day 1, day 7, and day 14
Time to Return to Normal Activities
Time frame: Up to 30 days postoperatively
Postoperative Paresthesia Incidence
Time frame: Postoperative day 7, day 30, and day 90
Endovenous Heat-Induced Thrombosis (EHIT) Incidence
Time frame: Postoperative day 7
Great Saphenous Vein Occlusion Rate
Time frame: Postoperative day 30 and day 90
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2026.
- Individual participant dataSharing planned: No. Individual participant data will not be shared due to local data protection regulations and limited resources for data anonymization and management.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Oguz Arslanturk, MD principal investigator
Zonguldak Bulent Ecevit University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing calcium dobesilate in people with Varicose Veins Leg and Great Saphenous Vein Insufficiency, run by Oguz Arslanturk at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 5 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Oguz Arslanturk, MD (+905395613887, oguz.arslanturk@beun.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative Pain Score (VAS) (time frame: Postoperative day 7). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Feb 2026.