NIPH Clinical Trials Search

JAPANESE
国立保健医療科学院
JRCT ID: jRCT1030210271

Registered date:24/08/2021

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

Basic Information

Recruitment status Recruiting
Health condition(s) or Problem(s) studiedKlippel Trenaunay Weber syndrome
Date of first enrollment24/08/2021
Target sample size20
Countries of recruitmentJapan
Study typeInterventional
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 OutcomeComparison value of the circumference of the affected lower leg with respect to the circumference of the non-affected lower leg.
Secondary OutcomeMeasuring 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 maximumNot applicable
GenderBoth
Include criteriaPatients 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 criteriaPatients 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

Contact

Public contact
Name Shunsuke Yuzuriha
Address 3-1-1 Asahi, Matsumoto, Nagano, 390-8621 Nagano Japan 390-8621
Telephone +81-263-37-2833
E-mail yuzuriha@shinshu-u.ac.jp
Affiliation Shinshu University
Scientific contact
Name Shunsuke Yuzuriha
Address 3-1-1 Asahi, Matsumoto, Nagano, 390-8621 Nagano Japan 390-8621
Telephone +81-263-37-2833
E-mail yuzuriha@shinshu-u.ac.jp
Affiliation Shinshu University