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Finding the safer and more effective treatment option for below knee perforators

Comparative study of the safety and efficacy of perforator ligation vs foam sclerotherapy for below knee perforators - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
CTRI
Registry ID
CTRI/2025/09/095426
Enrollment
50
Registered
2025-09-26
Start date
Unknown
Completion date
Unknown
Last updated
2025-10-13

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

Conditions

Health Condition 1: I83- Varicose veins of lower extremities

Interventions

Intervention1: Perforator ligation: Perforator ligation of incompetent below knee perforators performed by standard surgical technique Intervention2: Foam sclerotherapy: Foam sclerotherapy for incomp

Sponsors

Dr Kumar Shivam
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1.Adults aged 18 and above 2.Diagnosed with symptomatic varicose veins with incompetent perforators confirmed by Doppler ultrasound 3.Undergoing perforator ligation or foam sclerotherapy for below knee perforators, irrespective of the simultaneous appropriate above-knee treatment (Trendelenberg s procedure/RFA/EVLA)

Exclusion criteria

Exclusion criteria: 1.Pregnant or breastfeeding women 2.Patients with active deep vein thrombosis (DVT)

Design outcomes

Secondary

MeasureTime frame
To compare the incidence of post-operative complications between the two treatment groups Timepoint: clinical examination for post-op complications on POD-2 and first follow up visit;To assess and compare the post-operative pain in both treatment groups using VAS scaleTimepoint: pain evaluation using VAS scale on POD-0 and POD-1;To compare the time to return to normal daily activities in each treatment groupTimepoint: to be asked to the patients via telephonic interview at 3 months.—

Primary

MeasureTime frame
To compare the efficacy of perforator ligation and foam sclerotherapy in the management of below knee perforators, based on quality of life improvement assessed using the CIVIQ 14 questionnaireTimepoint: To compare the efficacy of perforator ligation and foam sclerotherapy in the management of below knee perforators, based on quality of life improvement assessed using the CIVIQ 14 questionnaire at baseline(pre-operatively in person) and at 3 months post-op(via telephonic interview).—

Countries

India

Contacts

Public ContactDr Pavan M Bhat

Kasturba Medical College, Manipal

rajgopal.shenoy@manipal.edu9845243460

Outcome results

None listed

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