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Acetylsalicylic Acid Versus Placebo as an add-on Treatment to Local Non-steroidal Anti-inflammatory Drug for the Management of Thrombotic Episodes in Superficial Venous Malformations in Children Aged 6 to 17 Years.

NCT07663825 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 34

Last updated 2026-06-23

No results posted yet for this study

Summary

Superficial venous malformations (SVMs) are rare congenital anomalies that present as bluish masses. These masses may be focal, with limited skin involvement, or segmental, with more extensive involvement. They may be associated with syndromic conditions such as blue rubber nevus syndrome.

SVMs are characterised by a progressive worsening course, with repeated episodes of superficial venous thrombosis occurring. These episodes become more frequent over time, causing acute, intense and often highly debilitating pain.

To limit progression and in cases of functional impairment, long-term treatments may be offered. These include venous compression, targeted therapies such as mTOR inhibitors, and, where possible, surgical treatment or sclerotherapy.

However, the management of intra-SVM superficial venous thrombosis is not currently standardised, especially in the pediatric population. This study aims to evaluate the benefits of Acetylsalicylic acid (ASA) as an add-on treatment to local non-steroidal anti-inflammatory drug for the management of thrombotic episodes in superficial venous malformations in children aged 6 to 17 years.

Conditions

  • Venous Malformation, Low Flow
  • Venous Malformations

Interventions

DRUG

AAS at anti-inflammatory doses from 3 days to 14 days.

AAS at anti-inflammatory doses administered orally for a minimum of 3 days and a maximum of 14 days. Orally administered AAS is combined with the application of 1% diclofenac gel (NSAID) twice a day.

DRUG

Placebo from 3 days to 14 days.

Placebo administered orally for a minimum of 3 days and a maximum of 14 days. Oral placebo is combined with the application of 1% diclofenac gel (NSAID) twice a day.

DRUG

Application of Diclofenac gel 1% twice a day

Application of 1% diclofenac gel (NSAID) twice a day.

Sponsors & Collaborators

  • University Hospital, Tours

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

Min Age
6 Years
Max Age
17 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-09-30
Primary Completion
2030-09-30
Completion
2030-10-31

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07663825 on ClinicalTrials.gov