Vascular MalformationNCT07320430
Comparative Study Between Sclerosing Agents Used in Treatment of Vascular Malformation
A study testing sclerotherapy with intralesional injection of Ethanol for treatment of low-flow vascular malformatio, Sclerotherapy with intralesional bleomycin injection and Sclerotherapy with intralesional injection of polidocanol in people with Vascular Malformation, run by Ain Shams University at 1 site in Egypt.
Trial summary
This study aims to Compare the Efficacy and Safety of Different sclerosing Agents Used in Treatment of Low-Flow Vascular Malformation Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Vascular Malformation
- What is being tested?
- sclerotherapy with intralesional injection of Ethanol for treatment of low-flow vascular malformatio, Sclerotherapy with intralesional bleomycin injection and Sclerotherapy with intralesional injection of polidocanol
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 1 siteEgypt
- Study dates
- 14 Feb 2024to 15 Aug 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients with schobinger stage II, III low- flow vascular malformation.
- Lesion affecting Patients trunk and extremity..
- Patient accepting the risk of the procedure and sign the detailed informed - consent, and in case of children-age less than18 years old- the consent will be signed by the parents
Who cannot join
- Patient with high- flow vascular malformation.
- Patients with schobinger I and IV AVM.
- Lesion affecting face, head, and neck.
- Vascular tumours; haemangioma.
- Patient with hypersensitivity to embolic agents e.g., hypersensitivity to bleomycin.
- Patients with CKD and elevated serum creatinine level.
- Critically ill patients Including pulmonary diseases, insufficient cardiac and hepatorenal functions, systemic infection, haemorrhagic tendency.
- Patient who /or his parents don't accept the risk of our procedure and don't sign the detailed informed consent.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparative Study Between the Efficacy and Safety of Different Sclerosing Agents Used in Treatment of Low-Flow Vascular Malformation
This study aims to Compare the Efficacy and Safety of Different sclerosing Agents Used in Treatment of Low-Flow Vascular Malformation
Read the detailed description
This study aims to Compare the Efficacy and Safety of Different sclerosing Agents Used in Treatment of Low-Flow Vascular Malformation.
Study Population: Patients with low -flow vascular malformations who visit Ain Shams University hospitals outpatient clinic.
- Type of Study: Randomized Controlled Clinical Trial.
- Study Setting: Ain Shams University hospitals.
- Study Period: 18 months.
- Sample Size: 75 patients.
- Sampling Method: Convenient sample, divided into three equal groups by closed enveloped method.
- First group will receive ethanol, second group will receive bleomycin, and third group will receive polidocanol.
- Study procedure: patients will be lying flat supine or prone according to the anatomical site of the lesion, torniquet is applied over the draining vein , US guided puncture of the VM using 21gauge butterfly needle under local, regional or light general anaesthesia according to the topography of the lesion and patient's age, when flow seen, contrast is used to confirm correct access, visualization of the vascular channels and any connection with arterial or deep venous system, injection of the sclerosing agent under fluoroscopy showing contrast displacement.
- Ethanol 99.8% with maximum dose 1ml/kg/session, bleomycin (15 U per bottle) will be reconstituted with 10 mL of normal saline to a final concentration of 1.5 U/ML, then 4ml will be foamed with 6ml human albumin, polidocanol 3% will be foamed 1ml+4ml air to a maximum dose of 15 ml /session.
- First group will receive ethanol, second group will receive bleomycin, and third group will receive polidocanol.
- After injection, DSA to allow visualization of negative or reduced dye filling, needle will be removed, then compression with bandage except for ethanol group, with mean procedure time about 20 minutes
- Medications:
- Pre-operative: Prophylactic dose of anticoagulation will be given 5 days before operation for those with elevated D-dimer and will be continued for ten days post-operative.
- Intraoperative: Each patient will receive an injection of 0.5 mg/kg of corticosteroids during the procedure.
- Post-operative: PPI, oral corticosteroids- prednisolone 20mg once/day- for 5 days, anti-oedematous measures, and will be prescribed paracetamol tablets after the procedure.
- Follow up:
The investigators will follow those patients clinically, and radiologically (follow up US\&MRI selectively).
patients will be followed up few hours after operation, 2-4 weeks later between sessions, decision to continue the treatment or not will be made with the patient on the basis of the clinical efficacy. At the end of the treatment, patients will be followed up in a non-standardised manner up to 18 months, usually 1-3 months after the last session. When a consultation was not possible, telephone contact will be made with the patient.
- Conditions
- Vascular Malformation
- Being tested
- sclerotherapy with intralesional injection of Ethanol for treatment of low-flow vascular malformatio, Sclerotherapy with intralesional bleomycin injection, Sclerotherapy with intralesional injection of polidocanol
- Keywords
- low-flow, sclerosing, vascular malformation
- Medical subject headings
- Vascular Malformations
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
sclerotherapy with intralesional injection of Ethanol for treatment of low-flow vascular malformatioProcedure or surgery
First group will receive Ethanol. patients will be lying flat supine or prone according to the anatomical site of the lesion, US guided puncture of the vascular malformation (VM) using 21gauge butterfly needle under local, regional or light general anaesthesia according to the topography of the lesion and patient's age, when flow seen, contrast is used to confirm correct access, visualization of the vascular channels and any connection with arterial or deep venous system.
injection of the sclerosing agent(Ethanol 99.8% with maximum dose 1ml/kg/session ) under fluoroscopy showing contrast displacement.
After injection, DSA to allow visualization of negative or reduced dye filling, needle will be removed.
compression will not be done for this group for fear of complications ( post operative pain- skin gangrene)
Sclerotherapy with intralesional bleomycin injectionProcedure or surgery
second group will receive bleomycin. patients will be lying flat supine or prone according to the anatomical site of the lesion, US guided puncture of the vascular malformation (VM) using 21gauge butterfly needle under local, regional or light general anaesthesia according to the topography of the lesion and patient's age, when flow seen, contrast is used to confirm correct access, visualization of the vascular channels and any connection with arterial or deep venous system, injection of the sclerosing agent: bleomycin (15 U per bottle) will be reconstituted with 10 mL of normal saline to a final concentration of 1.5 U/ML, then 4ml will be foamed with 6ml human albumin, under fluoroscopy showing contrast displacement.
After injection, DSA to allow visualization of negative or reduced dye filling, needle will be removed, then compression with bandage will be done .
Sclerotherapy with intralesional injection of polidocanolProcedure or surgery
Third group will receive polidocanol. patients will be lying flat supine or prone according to the anatomical site of the lesion, torniquet is applied over the draining vein , US guided puncture of the VM using 21gauge butterfly needle under local, regional or light general anaesthesia according to the topography of the lesion and patient's age, when flow seen, contrast is used to confirm correct access, visualization of the vascular channels and any connection with arterial or deep venous system, injection of the sclerosing agent under fluoroscopy showing contrast displacement.
polidocanol 3% will be foamed 1ml+4ml air to a maximum dose of 15 ml /session. After injection DSA to DSA to allow visualization of negative or reduced dye filling, needle will be removed, then compression with bandage .
| Study group | Role | What they receive |
|---|---|---|
| first group(Ethanol) | Active comparator | * 25 patients receiving Ethanol 99.8% with maximum dose 1ml/kg/session
* sclerotherapy with intralesional injection of ethanol for treatment of low-flow vascular malformation. Receives: Procedure: sclerotherapy with intralesional injection of Ethanol for treatment of low-flow vascular malformatio |
| second group(Bleomycin) | Active comparator | 25 patients receiving bleomycin (15 U per bottle) will be reconstituted with 10 mL of normal saline to a final concentration of 1.5 U/ML, then 4ml will be foamed with 6ml human albumin.
sclerotherapy with intralesional injection of bleomycin for treatment of low-flow vascular malformation. Receives: Procedure: Sclerotherapy with intralesional bleomycin injection |
| third group(Polidocanol) | Active comparator | 25 patients receiving Polidocanol 3% which will be foamed 1ml+4ml air to a maximum dose of 15 ml /session. Receives: Procedure: Sclerotherapy with intralesional injection of polidocanol |
What is being measured
The primary outcome is the main question the study is designed to answer.
cure rate
cure rate defined as:
- Complete cure as 100% lesion devascularization on DSA or US with complete resolution of initial symptoms and signs.
- partial cure has been established as devascularization of 50%-99% with complete or partial resolution.
Measured: 3 months after the last procedure
Secondary outcomes (2)
Rate of complications .
1-Rate of complications including( pain, skin rash, hyperpigmentation, hypersensitivity reaction, PE
Measured: within1 months after the last procedure
patient satisfaction
Level of patient's satisfaction expressed through 5-point Likert scale.
Items included are:
- Post-Operative Pain Management .
- Cosmetic Improvement .
- Functional improvement .
- Communication with the investigator about the case (diagnosis\& management).
- Follow up after intervention.
Overall Lowest score (5)means worst outcome, while Overall highest score (25)means best outcome.
Measured: within 1 month after last procedure.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2026
- Study start14 Feb 2024
- Primary completion15 Jul 2025
- Study completion15 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vascular MalformationStudies of the same condition, open and under way.
- More trials run by Ain Shams UniversityThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mohamed A Hagag, Lecturer, MD vascular surgery, Study director, faculty of medicine Ain shams UniverisityAmr N kamel, professor of vascular surgery, Study director, faculty of medicine Ain shams UniverisityAyman A Mohamed, professor of vascular surgery, Study director, faculty of medicine Ain shams Univerisity
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07320430
- Sponsor's protocol ID
- FMASU MD15/2024
- Status last verified
- Jun 2025
- First submitted
- 15 Jun 2025
- Last updated
- 6 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All available demographic data, photos taken before, during and after procedures, results can be shared
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Study Between the Efficacy and Safety of Different Sclerosing Agents Used in Treatment of Low-Flow Vascular Malformation
- ClinicalTrials.gov ID
- NCT07320430
- Acronym / sponsor ID
- FMASU MD15/2024
- Conditions
- Vascular Malformation
- Keywords
- low-flow, sclerosing, vascular malformation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 14 Feb 2024 (actual)
- Primary completion
- 15 Jul 2025 (actual)
- Study completion
- 15 Aug 2025 (actual)
- First posted
- 6 Jan 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.
This study aims to Compare the Efficacy and Safety of Different sclerosing Agents Used in Treatment of Low-Flow Vascular Malformation
Detailed description
This study aims to Compare the Efficacy and Safety of Different sclerosing Agents Used in Treatment of Low-Flow Vascular Malformation.
Study Population: Patients with low -flow vascular malformations who visit Ain Shams University hospitals outpatient clinic.
- Type of Study: Randomized Controlled Clinical Trial.
- Study Setting: Ain Shams University hospitals.
- Study Period: 18 months.
- Sample Size: 75 patients.
- Sampling Method: Convenient sample, divided into three equal groups by closed enveloped method.
- First group will receive ethanol, second group will receive bleomycin, and third group will receive polidocanol.
- Study procedure: patients will be lying flat supine or prone according to the anatomical site of the lesion, torniquet is applied over the draining vein , US guided puncture of the VM using 21gauge butterfly needle under local, regional or light general anaesthesia according to the topography of the lesion and patient's age, when flow seen, contrast is used to confirm correct access, visualization of the vascular channels and any connection with arterial or deep venous system, injection of the sclerosing agent under fluoroscopy showing contrast displacement.
- Ethanol 99.8% with maximum dose 1ml/kg/session, bleomycin (15 U per bottle) will be reconstituted with 10 mL of normal saline to a final concentration of 1.5 U/ML, then 4ml will be foamed with 6ml human albumin, polidocanol 3% will be foamed 1ml+4ml air to a maximum dose of 15 ml /session.
- First group will receive ethanol, second group will receive bleomycin, and third group will receive polidocanol.
- After injection, DSA to allow visualization of negative or reduced dye filling, needle will be removed, then compression with bandage except for ethanol group, with mean procedure time about 20 minutes
- Medications:
- Pre-operative: Prophylactic dose of anticoagulation will be given 5 days before operation for those with elevated D-dimer and will be continued for ten days post-operative.
- Intraoperative: Each patient will receive an injection of 0.5 mg/kg of corticosteroids during the procedure.
- Post-operative: PPI, oral corticosteroids- prednisolone 20mg once/day- for 5 days, anti-oedematous measures, and will be prescribed paracetamol tablets after the procedure.
- Follow up:
The investigators will follow those patients clinically, and radiologically (follow up US\&MRI selectively).
patients will be followed up few hours after operation, 2-4 weeks later between sessions, decision to continue the treatment or not will be made with the patient on the basis of the clinical efficacy. At the end of the treatment, patients will be followed up in a non-standardised manner up to 18 months, usually 1-3 months after the last session. When a consultation was not possible, telephone contact will be made with the patient.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| first group(Ethanol) | Active comparator | Procedure: sclerotherapy with intralesional injection of Ethanol for treatment of low-flow vascular malformatio* 25 patients receiving Ethanol 99.8% with maximum dose 1ml/kg/session * sclerotherapy with intralesional injection of ethanol for treatment of low-flow vascular malformation. |
| second group(Bleomycin) | Active comparator | Procedure: Sclerotherapy with intralesional bleomycin injection25 patients receiving bleomycin (15 U per bottle) will be reconstituted with 10 mL of normal saline to a final concentration of 1.5 U/ML, then 4ml will be foamed with 6ml human albumin. sclerotherapy with intralesional injection of bleomycin for treatment of low-flow vascular malformation. |
| third group(Polidocanol) | Active comparator | Procedure: Sclerotherapy with intralesional injection of polidocanol25 patients receiving Polidocanol 3% which will be foamed 1ml+4ml air to a maximum dose of 15 ml /session. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Patients with schobinger stage II, III low- flow vascular malformation.
- Lesion affecting Patients trunk and extremity..
- Patient accepting the risk of the procedure and sign the detailed informed - consent, and in case of children-age less than18 years old- the consent will be signed by the parents
Key exclusion criteria (8 listed)
- Patient with high- flow vascular malformation.
- Patients with schobinger I and IV AVM.
- Lesion affecting face, head, and neck.
- Vascular tumours; haemangioma.
- Patient with hypersensitivity to embolic agents e.g., hypersensitivity to bleomycin.
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 |
|---|---|---|
| sclerotherapy with intralesional injection of Ethanol for treatment of low-flow vascular malformatioFirst group will receive Ethanol. patients will be lying flat supine or prone according to the anatomical site of the lesion, US guided puncture of the vascular malformation (VM) using 21gauge butterfly needle under local, regional or light general anaesthesia according to the topography of the lesion and patient's age, when flow seen, contrast is used to confirm correct access, visualization of the vascular channels and any connection with arterial or deep venous system. injection of the sclerosing agent(Ethanol 99.8% with maximum dose 1ml/kg/session ) under fluoroscopy showing contrast displacement. After injection, DSA to allow visualization of negative or reduced dye filling, needle will be removed. compression will not be done for this group for fear of complications ( post operative pain- skin gangrene) | Procedure or surgery | first group(Ethanol) |
| Sclerotherapy with intralesional bleomycin injectionsecond group will receive bleomycin. patients will be lying flat supine or prone according to the anatomical site of the lesion, US guided puncture of the vascular malformation (VM) using 21gauge butterfly needle under local, regional or light general anaesthesia according to the topography of the lesion and patient's age, when flow seen, contrast is used to confirm correct access, visualization of the vascular channels and any connection with arterial or deep venous system, injection of the sclerosing agent: bleomycin (15 U per bottle) will be reconstituted with 10 mL of normal saline to a final concentration of 1.5 U/ML, then 4ml will be foamed with 6ml human albumin, under fluoroscopy showing contrast displacement. After injection, DSA to allow visualization of negative or reduced dye filling, needle will be removed, then compression with bandage will be done . | Procedure or surgery | second group(Bleomycin) |
| Sclerotherapy with intralesional injection of polidocanolThird group will receive polidocanol. patients will be lying flat supine or prone according to the anatomical site of the lesion, torniquet is applied over the draining vein , US guided puncture of the VM using 21gauge butterfly needle under local, regional or light general anaesthesia according to the topography of the lesion and patient's age, when flow seen, contrast is used to confirm correct access, visualization of the vascular channels and any connection with arterial or deep venous system, injection of the sclerosing agent under fluoroscopy showing contrast displacement. polidocanol 3% will be foamed 1ml+4ml air to a maximum dose of 15 ml /session. After injection DSA to DSA to allow visualization of negative or reduced dye filling, needle will be removed, then compression with bandage . | Procedure or surgery | third group(Polidocanol) |
Primary outcome
cure rate
Time frame: 3 months after the last procedure
cure rate defined as: 1. Complete cure as 100% lesion devascularization on DSA or US with complete resolution of initial symptoms and signs. 2. partial cure has been established as devascularization of 50%-99% with complete or partial resolution.
2 secondary outcomes
Rate of complications .
Time frame: within1 months after the last procedure
patient satisfaction
Time frame: within 1 month after last procedure.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jan 2026.
- Individual participant dataSharing planned: Yes. All available demographic data, photos taken before, during and after procedures, results can be shared
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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. This study is not recruiting at the moment.
Mohamed A Hagag, Lecturer, MD vascular surgery study director
faculty of medicine Ain shams Univerisity
Amr N kamel, professor of vascular surgery study director
faculty of medicine Ain shams Univerisity
Ayman A Mohamed, professor of vascular surgery study director
faculty of medicine Ain shams Univerisity
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing sclerotherapy with intralesional injection of Ethanol for treatment of low-flow vascular malformatio, Sclerotherapy with intralesional bleomycin injection and Sclerotherapy with intralesional injection of polidocanol in people with Vascular Malformation, run by Ain Shams University at 1 site in Egypt.
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 3 inclusion and 8 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: finished, as of the sponsor's last update on 6 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
cure rate (time frame: 3 months after the last procedure). 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 6 Jan 2026.