Multi-institutional clinical study to verify the efficacy and safety of wearing custom-made compression elastic garment for 6 months in cases of Klippel-Trenaunay syndrome with venous malformation

JRCT ID: jRCT1030210271

Registered date:24/08/2021

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Klippel Trenaunay Weber syndrome
• Date of first enrollment: 24/08/2021
• Target sample size: 20
• Study type: Interventional
• Intervention(s): Compression therapy by wearing the custom-made elastic garment for 26 weeks, Stopping the ongoing compression therapy using the elastic bandage or the srtandard garment 3 days before measuring the affected leg to make the custom-made elastic garment.

Outcome(s)

• Primary Outcome: Comparison value of the circumference of the affected lower leg with respect to the circumference of the non-affected lower leg.

Secondary Outcome

Measuring water content of the affected leg using the bioelectrical impedance analysis.
Pain evaluation using the 5-point visual analogue scale.
The modified Rankin Scale based on activities of daily living.
Blood pressure and heart pulsation values.
Elasytic strength of the garment material.

Key inclusion & exclusion criteria

• Age minimum: >= 2age old
• Age maximum: Not applicable
• Gender: Both
• Include criteria: Patients who have some typess of vascular malformations including venous malformation on the unilateral lower leg, are dagnosed as Klippel-Trenaunay syndorome, and can walk independently.
• Exclude criteria: Patients who have bilateral lesions, those who had treated by sclerotherpy or surgery in 12 weeks, those who have allergic reactions to materials of the elastic garment, those who are continuously administered diuretic medicine to, and those who suffered from heart failure within 1 year.

Related Information

• Primary Sponsor: Yuzuriha Shunsuke
• Secondary Sponsor: The Health, Labor and Welfare Sciences Research Grants (Research on Measures for Intractable Diseases), Research Committee for Intractable Vascular Anomalies (a representative: Sadanori Akita)