Venous Malformation, Low FlowPhase 2ASPIRINNCT07663825
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.
A Phase 2 study testing AAS at anti-inflammatory doses from 3 days to 14 days. and Application of Diclofenac gel 1% twice a day in people with Venous Malformation, Low Flow and Venous Malformations, run by University Hospital, Tours at 6 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 6 to 17 years
- Conditions the study is for
- Venous Malformation, Low Flow, Venous Malformations
- What is being tested?
- AAS at anti-inflammatory doses from 3 days to 14 days. and Application of Diclofenac gel 1% twice a day
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 34 participants
- Where
- 6 sitesFrance
- Study dates
- Sep 2026to 31 Oct 2030
- Phase
- Phase 2
- 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 6 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Patients aged 6 to 17 years
- Weight ≥ 20 kg
- Isolated or combined superficial venous malformation, confirmed by imaging, with the presence of phleboliths indicating the occurrence of previous superficial venous thrombosis
- Complicated by acute thrombotic episodes (2 or more in the previous 12 months)
- Written consent of the child's legal representatives or of the participant if over 18 years of age
- Affiliation of a social security scheme
- Highly effective contraception for young women of childbearing age
Who cannot join
- Patients with deep or syndromic venous malformation
- Patients with known G6PD deficiency
- Patients with known mastocytosis
- History of hemarthrosis
- Simultaneous participation in another biomedical study
- Constitutional or acquired haemostasis pathology
Show all 15Show fewer
- Current treatment affecting haemostasis (anticoagulants, platelet anti aggregants, oral NSAIDs)
- Frequent bleeding (epistaxis, other) requiring management
- Basic treatment of venous malformation (mTOR inhibitor)
- Active neoplasia or infection (altered coagulation balance)
- Known allergy to acetylsalicylic acid
- Injured skin, whatever the lesion: oozing dermatitis, eczema, infected lesions, burns or wounds
- Pregnant and breastfeeding women
- Severe renal insufficiency, severe hepatic insufficiency, severe uncontrolled cardiac insufficiency
- Methotrexate ≥ 20 mg/week
Trial locations and contacts
6 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Coralie TAILLEBUIS contact
6 sites in 1 country
France6 sites
Centre Hospitalier Universitaire d'Angers
Angers
Ludovic MARTIN, +332 41 35 34 19, lumartin@chu-angers.fr
Centre Hospitalier Universitaire de Brest
Brest
Claire ABASQ-THOMAS, +332 98 22 33 15, claire.abasq@chu-brest.fr
AP-HM
Marseille
Stéphanie MALLET, +334 91 38 88 01, Stephanie.MALLET@ap-hm.fr
Centre Hospitalier Universitaire de Nantes
Nantes
Sébastien BARBAROT, MD, +332 40 08 40 86, sebastien.barbarot@chu-nantes.fr
AP-HP
Paris
Olivia BOCCARA, +331 44 49 46 63, olivia.boccara@aphp.fr
Centre Hospitalier Universitaire de Rennes
Rennes
Catherine DROITCOURT, +332 99 28 98 89, catherine.droitcourt@chu-rennes.fr
About this study
Official title: 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: a Controlled Randomised, Double-blind, Cross-over, Multicenter Trial
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.
Read more
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.
- Being tested
- AAS at anti-inflammatory doses from 3 days to 14 days., Placebo from 3 days to 14 days., Application of Diclofenac gel 1% twice a day
- Keywords
- superficial venous thrombosis, superficial venous malformations, acetylsalicylic acid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AAS at anti-inflammatory doses from 3 days to 14 days.Drug
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.
Placebo from 3 days to 14 days.Drug
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.
Application of Diclofenac gel 1% twice a dayDrug
Application of 1% diclofenac gel (NSAID) twice a day.
| Study group | Role | What they receive |
|---|---|---|
| ASA + local NSAID then placebo + local NSAIDs | Other | This is a cross-over design. Patients randomized in this sequence will receive ASA + local NSAIDs during their first flare-up, then placebo + local NSAIDs during their second flare-up (with a wash out period of two weeks). Receives: Drug: AAS at anti-inflammatory doses from 3 days to 14 days.; Drug: Placebo from 3 days to 14 days.; Drug: Application of Diclofenac gel 1% twice a day |
| Placebo + local NSAID then AAS + local NSAIDs | Other | This is a cross-over design. Patients randomized in this sequence will receive placebo + local NSAIDs during their first flare-up, then AAS + local NSAIDs during their second flare-up (with a wash out period of two weeks). Receives: Drug: AAS at anti-inflammatory doses from 3 days to 14 days.; Drug: Placebo from 3 days to 14 days.; Drug: Application of Diclofenac gel 1% twice a day |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary criterion is the total pain experienced during the episode, reflecting both intensity and duration.
Pain intensity will be measured using a visual analog scale (VAS) ranging from 0 (no pain) to 10 (the most intense pain imaginable). The child will self-assess their pain, with a parent's help if necessary, twice a day (morning and evening). The area under the EVA-time curve is calculated using the trapezoidal method based on the available values over the duration of the episode.
Measured: The first measurement is defined as the start of treatment following the onset of pain reported by the child. VAS data will be collected until the child has a VAS of 0 for two consecutive days, or for up to 14 days.
Secondary outcomes (12)
Total consumption of analgesics
Total consumption of analgesics over the 14-day period. Each day, parents will record in a patient logbook, in addition to the pain VAS score, all medication doses (study medications and others)
Measured: Over the 14-day period after the start of treatment
Child's quality of life
Child's quality of life as measured by the C-DLQI [Children's Dematology Quality of Life Index] scoring from 0 to 30, 0-1 = no effect on child's life · 2-6 = small effect · 7-12 = moderate effect · 13-18 = very large effect · 19-30 = extremely large effect.
Measured: At baseline and 2 weeks after the start of the treatment;
Child's quality of life
Child's quality of life measured by the CLFMQol [Specific Quality of Life Questionnaire for Slow-Flow Vascular Malformations] including 15 items, with a total score ranging from 0 to 45, 0 being the worst value and 45 the best value.
Measured: At baseline and 2 weeks after the start of the treatment;
Sleep quality
Fast Score SLEEP VASC a scale scoring from 0 to 10, 10 being the best sleep quality
Measured: Measured once a day for 14 days
Functional impairment
Functional impairment related to the malformation will be assessed using a VAS ranging from 0 to 10 (0 = no discomfort, 10 = maximum discomfort; inability to move a limb or body segment)
Measured: Daily over 14 days, at baseline and 2 weeks after the start of the treatment;
Coagulation markers: Hemoglobin
Hemoglobin
Measured: At baseline, within 72 hours after the start of the treatment, and 2 weeks after the start of the treatment
Coagulation markers: Platelets
Platelets
Measured: At baseline, within 72 hours after the start of the treatment, and 2 weeks after the start of the treatment
Coagulation markers: Prothrombin time
Prothrombin time
Measured: At baseline, within 72 hours after the start of the treatment, and 2 weeks after the start of the treatment
Coagulation markers: Activated partial thromboplastin time
Activated partial thromboplastin time
Measured: At baseline, within 72 hours after the start of the treatment, and 2 weeks after the start of the treatment
Coagulation markers: Fibrinogen
Fibrinogen
Measured: At baseline, within 72 hours after the start of the treatment, and 2 weeks after the start of the treatment
Coagulation markers: D-dimer
D-dimer
Measured: At baseline, within 72 hours after the start of the treatment, and 2 weeks after the start of the treatment
Coagulation markers: Factor V
Factor V
Measured: At baseline, within 72 hours after the start of the treatment, and 2 weeks after the start of the treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2026
- Study startSep 2026 (estimated)
- Primary completionSep 2030 (estimated)
- Study completion31 Oct 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Venous Malformation, Low FlowStudies of the same condition, open and under way.
- More trials run by University Hospital, ToursThe sponsor's other registered studies.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- This is a cross-over design with a wash out period of two weeks.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 34 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Tours
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07663825
- Sponsor's protocol ID
- DR200086
- Other IDs
- 2024-517595-38-00
- Acronym
- ASPIRIN
- Status last verified
- Jun 2026
- First submitted
- 26 May 2026
- Last updated
- 23 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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: a Controlled Randomised, Double-blind, Cross-over, Multicenter Trial
- ClinicalTrials.gov ID
- NCT07663825
- Acronym / sponsor ID
- ASPIRIN / DR200086
- Keywords
- superficial venous thrombosis, superficial venous malformations, acetylsalicylic acid
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 34 participants (estimated)
- Lead sponsor
- University Hospital, ToursUniversity, hospital or other
- Study start
- Sep 2026 (estimated)
- Primary completion
- Sep 2030 (estimated)
- Study completion
- 31 Oct 2030 (estimated)
- First posted
- 23 Jun 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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- This is a cross-over design with a wash out period of two weeks.
| Arm | Type | Receives |
|---|---|---|
| ASA + local NSAID then placebo + local NSAIDs | Other | Drug: AAS at anti-inflammatory doses from 3 days to 14 days., Drug: Placebo from 3 days to 14 days., Drug: Application of Diclofenac gel 1% twice a dayThis is a cross-over design. Patients randomized in this sequence will receive ASA + local NSAIDs during their first flare-up, then placebo + local NSAIDs during their second flare-up (with a wash out period of two weeks). |
| Placebo + local NSAID then AAS + local NSAIDs | Other | Drug: AAS at anti-inflammatory doses from 3 days to 14 days., Drug: Placebo from 3 days to 14 days., Drug: Application of Diclofenac gel 1% twice a dayThis is a cross-over design. Patients randomized in this sequence will receive placebo + local NSAIDs during their first flare-up, then AAS + local NSAIDs during their second flare-up (with a wash out period of two weeks). |
Who may qualify
- Ages
- 6 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- Patients aged 6 to 17 years
- Weight ≥ 20 kg
- Isolated or combined superficial venous malformation, confirmed by imaging, with the presence of phleboliths indicating the occurrence of previous superficial venous thrombosis
- Complicated by acute thrombotic episodes (2 or more in the previous 12 months)
- Written consent of the child's legal representatives or of the participant if over 18 years of age
Key exclusion criteria (15 listed)
- Patients with deep or syndromic venous malformation
- Patients with known G6PD deficiency
- Patients with known mastocytosis
- History of hemarthrosis
- Simultaneous participation in another biomedical study
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 |
|---|---|---|
| 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 | ASA + local NSAID then placebo + local NSAIDs, Placebo + local NSAID then AAS + local NSAIDs |
| 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 | ASA + local NSAID then placebo + local NSAIDs, Placebo + local NSAID then AAS + local NSAIDs |
| Application of Diclofenac gel 1% twice a dayApplication of 1% diclofenac gel (NSAID) twice a day. | Drug | ASA + local NSAID then placebo + local NSAIDs, Placebo + local NSAID then AAS + local NSAIDs |
Primary outcome
The primary criterion is the total pain experienced during the episode, reflecting both intensity and duration.
Time frame: The first measurement is defined as the start of treatment following the onset of pain reported by the child. VAS data will be collected until the child has a VAS of 0 for two consecutive days, or for up to 14 days.
Pain intensity will be measured using a visual analog scale (VAS) ranging from 0 (no pain) to 10 (the most intense pain imaginable). The child will self-assess their pain, with a parent's help if necessary, twice a day (morning and evening). The area under the EVA-time curve is calculated using the trapezoidal method based on the available values over the duration of the episode.
12 secondary outcomes
Total consumption of analgesics
Time frame: Over the 14-day period after the start of treatment
Child's quality of life
Time frame: At baseline and 2 weeks after the start of the treatment;
Child's quality of life
Time frame: At baseline and 2 weeks after the start of the treatment;
Sleep quality
Time frame: Measured once a day for 14 days
Functional impairment
Time frame: Daily over 14 days, at baseline and 2 weeks after the start of the treatment;
Coagulation markers: Hemoglobin
Time frame: At baseline, within 72 hours after the start of the treatment, and 2 weeks after the start of the treatment
Coagulation markers: Platelets
Time frame: At baseline, within 72 hours after the start of the treatment, and 2 weeks after the start of the treatment
Coagulation markers: Prothrombin time
Time frame: At baseline, within 72 hours after the start of the treatment, and 2 weeks after the start of the treatment
Coagulation markers: Activated partial thromboplastin time
Time frame: At baseline, within 72 hours after the start of the treatment, and 2 weeks after the start of the treatment
Coagulation markers: Fibrinogen
Time frame: At baseline, within 72 hours after the start of the treatment, and 2 weeks after the start of the treatment
Coagulation markers: D-dimer
Time frame: At baseline, within 72 hours after the start of the treatment, and 2 weeks after the start of the treatment
Coagulation markers: Factor V
Time frame: At baseline, within 72 hours after the start of the treatment, and 2 weeks after the start of the treatment
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 23 Jun 2026.
- Individual participant dataSharing planned: No
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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.
Coralie TAILLEBUIS contact
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing AAS at anti-inflammatory doses from 3 days to 14 days. and Application of Diclofenac gel 1% twice a day in people with Venous Malformation, Low Flow and Venous Malformations, run by University Hospital, Tours at 6 sites in France.
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 7 inclusion and 15 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 23 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in France. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 Sophie LEDUCQ, MD, PhD (+332 47 47 56 02, S.LEDUCQ@chu-tours.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The primary criterion is the total pain experienced during the episode, reflecting both intensity and duration. (time frame: The first measurement is defined as the start of treatment following the onset of pain reported by the child. VAS data will be collected until the child has a VAS of 0 for two consecutive days, or for up to 14 days.). 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 23 Jun 2026.