Pilot study added value intermittent vacuum therapy (IVT)

Recruiting

• Conditions: intermittent claudication; peripheral arterial disease; 10003216

• Registration Number: NL-OMON44065
• Lead Sponsor: Catharina-ziekenhuis

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
• Sufficiently motivated to participate in the study (particularly additional (travel) time investment for treatment with IVT in the 'Been-Kliniek' in Eindhoven)
• Informed consent

Exclusion Criteria

• Previous treatment for PAD in the past 2 years (conservative and/or invasive technique)
• Prior treatment with IVT (possibly for other indications than PAD)
• Cognitive disabilities
• Inadequate control of the Dutch language
• Contraindications for IVT (pregnancy, infection and/or inflammation of the lower limb(s), abdominal wall hernia)
• Recent (<6 weeks) trauma of the lower limb(s)
• Severe cox- or gonarthrosis and planned joint replacement therapy

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Maximum walking distance after 6 and 12 weeks, 6 months and 1 year, measured by<br /><br>a standardized treadmill test .</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Functional walking distance after 6 and 12 weeks, 6 months and 1 year, measured<br /><br>by a standardized treadmill test .<br /><br>Quality of life and walking disability after 6 and 12 weeks, 6 months and 1<br /><br>year, measured by questionnaires.</p><br>