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Compare Two Different Sclerosing Agents in the Treatment of Venous Malformations

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

Status
UNKNOWN
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01347294
Enrollment
135
Registered
2011-05-04
Start date
2011-08-31
Completion date
2025-06-30
Last updated
2023-11-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Venous Malformation

Brief summary

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

Detailed 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.

Interventions

DRUGBleomycin

Intralesional

DRUGFibrovein

Intralesional

DRUGBleomycin + Fibrovein

Intralesional

Sponsors

Oslo University Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
12 Years to 80 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Intesity, frequency and type of pain.1 yearPain 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.

Countries

Norway

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026