Pilot study added value intermittent vacuum therapy (IVT) in the treatment of intermittent claudicatio

Recruiting

• Conditions: Peripheral arterial disease; Intermittent claudication; Perifeer arteriaal vaatlijden; Claudicatio intermittens

• Registration Number: NL-OMON26769
• Lead Sponsor: Catharina Hospital, Eindhoven, the Netherlands

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 11 June 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: 80

Inclusion Criteria

Conservative treatment with supervised exercise therapy (SET)

-Sufficient additional insurance or sufficient financial resources for a SET program of 1 year

Exclusion Criteria

-Maximal walking distance >1000 meters at baseline

-Inability to complete 12 IVT sessions in first 12 weeks (vacation)

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Maximal walking distance, measured by a standardized treadmill test

Secondary Outcome Measures

Name	Time	Method
-Functional walking distance, measured by a standardized treadmill test<br /><br>-Walking distance, measured by a six-minute walk test<br /><br>-General quality of life, measured by a EQ-5D questionnaire<br /><br>-Disease-specific quality of life, measured by a VascuQol questionnaire<br /><br>-Walking impairment, measured by a WIQ questionnaire