Treatment of Venous Malformation

• Sponsor: Al-Azhar University (Other)
• Overall Status: Completed
• CT.gov ID: NCT05586919
• Collaborator: (none)
• Enrollment: 20
• Location: 1
• Arms: 2
• Actual Duration (Months): 29
• Patients Per Site Per Month: 0.7

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Venous Malformation	Procedure: Direct Puncture Repair / Ethanol; Procedure: Direct Puncture Repair / Polidocanol	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 20 participants
• Allocation: Non-Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Treatment of Venous Malformation by Direct Puncture Repair: Ethanol Versus Polidocanol
• Actual Study Start Date: Oct 1, 2018
• Actual Primary Completion Date: Jan 1, 2021
• Actual Study Completion Date: Mar 1, 2021

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Direct Puncture Repair / Ethanol	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
Active Comparator: Direct Puncture Repair / Polidocanol	Procedure: Direct Puncture Repair / Polidocanol; Polidocanol is a sclerosing agent that will be injected in the venous malformation by Direct Puncture Repair

Outcome Measures

Primary Outcome Measures

1. Heaviness questionnaire [6 months post operative]

   Heaviness of the affected part may be unchanged, or decreased or disppeared, or relapsed

2. Disfigurement questionnaire [6 months post operative]

   Disfigurementof the affected part may be unchanged, or decreased or disppeared, or relapsed

3. 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

4. Degree of satisfaction [6 months post operative]

   It may be; Very satisfied, or satisfied, or not satisfied, or Dissatisfied.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Months to 36 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Walied Khereba	Zagazig		Egypt

Sponsors and Collaborators

• Al-Azhar University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Walied Khereba, Principal Investigator, Al-Azhar University
• ClinicalTrials.gov Identifier: NCT05586919
• Other Study ID Numbers: Venous Malformation
• First Posted: Oct 19, 2022
• Last Update Posted: Oct 19, 2022
• Last Verified: Oct 1, 2022

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Congenital Abnormalities; Ethanol; Polidocanol

Study Results

No Results Posted as of Oct 19, 2022