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SCLEROTHERAPY FOR MANAGEMENT OF VENOUS MALFORMATION.

EVALUATION OF COMPARATIVE EFFICACY OF COMBINATION SCLEROTHERAPY AGAINST SINGLE AGENT SCLEROTHERAPY FOR TREATMENT OF SLOW FLOW PERIPHERAL VASCULAR MALFORMATION: A RANDOMIZED CONTROLLED TRIAL. - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2026/07/114140
Enrollment
92
Registered
2026-07-16
Start date
Unknown
Completion date
Unknown
Last updated
2026-08-03

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

Conditions

Health Condition 1: I878- Other specified disorders of veins

Interventions

Intervention1: Combination sclerosant agent: Combination of 2 ml of sodium tetradecyl sulfate + 2 ml lipiodol + 6 ml (12IU) bleomycin. Intervention will be carried out every 4 weeks depending on the r

Sponsors

Datta Meghe Institue of Higher Education and Research
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Patients having slow flow vascular malformation who have not undergone any invasive intervention for venous malformation. Patients willing to participate in study and giving written informed consent.

Exclusion criteria

Exclusion criteria: Patients having high flow vascular malformation. Patients with slow flow vascular malformation who had underwent prior invasive intervention. Pregnant women with slow flow vascular malformation. Patients not willing to participate and not giving consent for the study.

Design outcomes

Primary

MeasureTime frame
post-intervention change in size of vascular malformationTimepoint: post-intervention change in size of vascular malformation at every sclerotherapy cycle and 3 months after last cycle of sclerotherapy

Secondary

MeasureTime frame
Secondary outcome in form of any adverse effects of sclerotherapy in intervention & control group.Timepoint: Adverse events if present will be recorded during every sclerotherapy session & during follow up period at 3 months after last cycle of sclerotherapy.

Countries

India

Contacts

Public ContactDr NAMRATA

Datta meghe Institue of Higher Education and Research, Sawangi meghe, Wardha, Maharashtra

pjbanode@gmail.com9960713020

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Aug 10, 2026