Treatment of Venous Malformation

Venous Malformation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05586919
• Other study ID #: Venous Malformation
• Status: Completed
• Phase: N/A
• Start date: October 1, 2018
• Est. completion date: March 1, 2021

Study information

• Verified date: October 2022
• Source: Al-Azhar University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: March 1, 2021
• Est. primary completion date: January 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Months to 36 Years

Eligibility

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.

Related Conditions & MeSH terms

• Congenital Abnormalities
• Venous Malformation

Intervention

Procedure:
• Direct Puncture Repair / Ethanol
Ethanol is an organic compound that will be injected in the venous malformation as a sclerotherapy by Direct Puncture Repair
• Direct Puncture Repair / Polidocanol
Polidocanol is a sclerosing agent that will be injected in the venous malformation by Direct Puncture Repair

Locations

Country	Name	City	State
Egypt	Walied Khereba	Zagazig

Sponsors (1)

Lead Sponsor	Collaborator
Al-Azhar University

Country where clinical trial is conducted

Egypt, 

Outcome

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