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 malformatio
- Conditions
- Klippel Trenaunay Weber syndromeD007715
- Registration Number
- JPRN-jRCT1030210271
- Lead Sponsor
- Yuzuriha Shunsuke
- Brief Summary
Wearing custom-made compression elastic garments for 6 months suppressed the increase in circumference of the tibial tuberosity and Achilles tendon in the affected limbs of patients with Klippel-Trenaunay-Weber syndrome. The elasticity of compression elastic garments was halved after six months of use. No serious adverse events occurred due to wearing them.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 20
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.
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Comparison value of the circumference of the affected lower leg with respect to the circumference of the non-affected lower leg.
- Secondary Outcome Measures
Name Time Method Measuring water content of the affected leg using the bioelectrical impedance analysis.<br>Pain evaluation using the 5-point visual analogue scale.<br>The modified Rankin Scale based on activities of daily living.<br>Blood pressure and heart pulsation values.<br>Elasytic strength of the garment material.