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Treatment of Venous Malformation

Primary Purpose

Venous Malformation

Status

Completed

Phase

Not Applicable

Locations

Egypt

Study Type

Interventional

Intervention

Direct Puncture Repair / Ethanol

Direct Puncture Repair / Polidocanol

About this trial

This is an interventional treatment trial for Venous Malformation

Eligibility Criteria

18 Months - 36 Years (Child, Adult)All SexesDoes not accept 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.

Sites / Locations

Walied Khereba

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

Direct Puncture Repair / Ethanol

Direct Puncture Repair / Polidocanol

Arm Description

Outcomes

Primary Outcome Measures

Heaviness questionnaire

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

Disfigurement questionnaire

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

size of venous malformation

it assess the size of malformations after injection; which may be unchanged, or decreased or disppeared, or relapsed

Degree of satisfaction

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

Secondary Outcome Measures

Full Information

NCT ID

NCT05586919

First Posted

October 1, 2022

Last Updated

October 16, 2022

Sponsor

Al-Azhar University

1. Study Identification

Unique Protocol Identification Number

NCT05586919

Brief Title

Treatment of Venous Malformation

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2022

Overall Recruitment Status

Completed

Study Start Date

October 1, 2018 (Actual)

Primary Completion Date

January 1, 2021 (Actual)

Study Completion Date

March 1, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Al-Azhar University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Venous Malformation

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

20 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Direct Puncture Repair / Ethanol

Arm Type

Active Comparator

Arm Title

Direct Puncture Repair / Polidocanol

Arm Type

Active Comparator

Intervention Type

Procedure

Intervention Name(s)

Direct Puncture Repair / Ethanol

Intervention Description

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

Intervention Type

Procedure

Intervention Name(s)

Direct Puncture Repair / Polidocanol

Intervention Description

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

Primary Outcome Measure Information:

Title

Heaviness questionnaire

Description

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

Time Frame

6 months post operative

Title

Disfigurement questionnaire

Description

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

Time Frame

6 months post operative

Title

size of venous malformation

Description

it assess the size of malformations after injection; which may be unchanged, or decreased or disppeared, or relapsed

Time Frame

6 months post operative

Title

Degree of satisfaction

Description

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

Time Frame

6 months post operative

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Months

Maximum Age & Unit of Time

36 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Facility Information:

Facility Name

Walied Khereba

City

Zagazig

Country

Egypt

12. IPD Sharing Statement

Learn more about this trial

Treatment of Venous Malformation

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