Compare Two Different Sclerosing Agents in the Treatment of Venous Malformations

Venous Malformation Clinical Trial

Official title:

Compare the Effect of Bleomycin and Tetradecyl Sodium Sulphate in the Treatment of Venous Malformations

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01347294
• Other study ID #: 1331TMF
• Secondary ID: TMF1331
• Status: Active, not recruiting
• Phase: Phase 4
• Start date: August 2011
• Est. completion date: June 30, 2025

Study information

• Verified date: November 2023
• Source: Oslo University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to determine the effectiveness of bleomycin, fibrovein and bleomycin and fibrovein in the treatment of venous malformation.

Description:

Patients with scanty symptoms from their vascular malformation can do well with conservative treatment and / or with aids and adaptations in daily life. Compression therapy (elastic stockings), pain medication and good counseling is adequate for many. Patients with significant symptoms, however, may require more invasive treatment. Previously, it was common with surgical removal, but serious sequelae and frequent recurrence after surgery resulted in caution. Today it is more common with intervention radiology treatment with injection of sclerosing agents into existing malformation. This type of therapy almost always requires repeated treatment sequences, sometimes over several months. Treatment aims to seal blood vessels in the malformation and / or make the patient as possible symptoms. Recurrence occurs frequently and there are many who are not completely free from symptoms. Many patients have chronic problems with pain, wounds, bleeding and / or they have a cosmetically disfiguring condition. Predicting the performance of a specific type of treatment can be very difficult.

Until now, there are some studies that have considered the effect of bleomycin / pingyangmycin (China) and ethanol in the treatment of vascular malformations. To our knowledge there is no prospective or retrospective studies that compare the efficacy and side effects of bleomycin and sodium tetradecyl sulfate (Fibrovein ™) in the treatment of VM.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 135
• Est. completion date: June 30, 2025
• Est. primary completion date: November 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years to 80 Years

Eligibility

Inclusion Criteria:

• Clinical diagnosis of Venous malformation

• Must be able to fill in questionary form

• Must be able to sign informed consent form

Exclusion Criteria:

• Kidney disease

• Lung disease

• Pregnancy or not willing to safe contraception

• Allergy to Bleomycin or Fibrovein

Related Conditions & MeSH terms

• Congenital Abnormalities
• Venous Malformation

Intervention

Drug:
• Bleomycin
Intralesional
• Fibrovein
Intralesional
• Bleomycin + Fibrovein
Intralesional

Locations

Country	Name	City	State
Norway	Oslo Universitetssykehus Rikshospitalet	Oslo

Sponsors (1)

Lead Sponsor	Collaborator
Oslo University Hospital

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Intesity, frequency and type of pain.	Pain will be measured before, during and after treatment. It will be asked about type, characteristics and intensity of pain. Using the Visual Analog Score 0-10, 0 beingno pain,10 being maximum pain, will be used in this matter.	1 year