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Comparing Open Cut Surgery Treatment of Varicose Veins of legs with Injection only Therapy

A Randomized controlled trial comparing efficacy, quality of life and cost effectiveness following ultrasound sclerotherapy in comparison to conventional surgery in varicose veins of lower limb

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2018/02/012224
Enrollment
60
Registered
2018-02-28
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: null- patients suffering from varicose veins of lower limb

Interventions

Intervention1: ultrasound guided foam sclerotherapy: under guidence of ultrasound, cannulated lower limb veins are injected foam sclrosant(sodium tetradecayl sulphate). Control Intervention1: conventi

Sponsors

AIIMS
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. All patients, in the age group 15-70 years with varicose veins. 2. Primary Varicose veins of lower limbs - long saphenous system with SFJ incompetence. 3. CEAP classification grade 2 to 6 4. Diameter of the varicose veins up to 10 mm 5. Patients who gave written informed consent

Exclusion criteria

Exclusion criteria: Patients who were unwilling or unable to provide informed consent 2 Patients who were less than 15, greater than 70 years of age 3 Patients with deep vein thrombosis 4 Patients with connective tissue disorders like SLE, vasculitis, thrombophilia, asthma, 5 Pregnancy, peripheral arterial disease, diabetic foot, neuropathy 6 Presence of patent foramen ovale on echocardiography. 7 Known allergy to local anaesthetics, sclerosants 8 Varicose vein diameter more then 11mm

Design outcomes

Primary

MeasureTime frame
1. The comparison of rate of recurrence of varicose veins in the two groupsTimepoint: 6 months

Secondary

MeasureTime frame
1.The comparison of rate of ulcer healing in the two groups 2.The comparison of pain relief in the two groups 3.The comparison of quality of life scores in the two groups 4.The comparison of cost-effectiveness of the two groups Timepoint: 6 months

Countries

India

Contacts

Public ContactDr Nitish Aggarwal

All India Institute of Medical Sciences

dranitadharbhan@gmail.com

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026