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OpenTrials
Completed

NCT Number: NCT05586919

Treatment of Venous Malformation

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.

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Key information

Conditions

Venous Malformation

Age range

18 month–36 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Walied Khereba

Zagazig, Egypt

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Direct Puncture Repair / Ethanol

Procedure

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

Direct Puncture Repair / Polidocanol

Procedure

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

Primary outcomes

  1. Heaviness questionnaire

    Time frame: 6 months post operative

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

  2. Disfigurement questionnaire

    Time frame: 6 months post operative

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

  3. size of venous malformation

    Time frame: 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

    Time frame: 6 months post operative

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

Sponsors and collaborators

Lead sponsor

Al-Azhar University

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2021
Study completion
2021
First posted
Oct 19, 2022
Registry last updated
Oct 19, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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