Treatment of Venous Malformation

Treatment of Venous Malformation by Direct Puncture Repair: Ethanol Versus Polidocanol

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05586919

Enrollment

Registered

2022-10-19

Start date

2018-10-01

Completion date

2021-03-01

Last updated

2022-10-19

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

Conditions

Venous Malformation

Brief summary

Vascular malformations are birth defects that happen when different stages of angiogenesis shut down. 44 - 64% of all vascular malformations are venous malformations (VMs). Sclerotherapy is the first treatment line for VMs. It acts by getting rid of the vascular endothelial cells in the lesion. One of the most common and well researched sclerosing agents for VMs is polidocanol, which is a popular counterpart for concentrated ethanol.

Interventions

PROCEDUREDirect Puncture Repair / Ethanol

Ethanol is an organic compound that will be injected in the venous malformation as a sclerotherapy by Direct Puncture Repair

PROCEDUREDirect Puncture Repair / Polidocanol

Polidocanol is a sclerosing agent that will be injected in the venous malformation by Direct Puncture Repair

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Months to 36 Years

Healthy volunteers

Inclusion criteria

* Patients diagnosed with venous malformation of both genders and age above one year.

Exclusion criteria

* Age below one year. * Patients had any other vascular malformations. * Indication for contrast material or Alcohol and polidocanol injection. * Unfit for general anesthesia. 5) Pregnancy. 6) Skin infection, inflammation, and ulcers. * Pulmonary embolism. * Acute Ischemia, and acute DVT.

Design outcomes

Primary

Measure	Time frame	Description
Heaviness questionnaire	6 months post operative	Heaviness of the affected part may be unchanged, or decreased or disppeared, or relapsed
Disfigurement questionnaire	6 months post operative	Disfigurementof the affected part may be unchanged, or decreased or disppeared, or relapsed
size of venous malformation	6 months post operative	it assess the size of malformations after injection; which may be unchanged, or decreased or disppeared, or relapsed
Degree of satisfaction	6 months post operative	It may be; Very satisfied, or satisfied, or not satisfied, or Dissatisfied.

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026