Critical limb ischemia: primary or secondary amputation versus intervention (bypass or PTA), impact at functional outcome.

• Conditions: critical vascular disease; Fontaine 3 & 4; 10003184; 10003216

• Registration Number: NL-OMON31138
• Lead Sponsor: Academisch Medisch Centrum

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 13 May 2024

Recruitment & Eligibility

• Status: Pending
• Sex: Not specified
• Target Recruitment: 200

Inclusion Criteria

Critical limb ischemia requiring therapy consisting of either a bypass or PTA or major lower limb amputation (below, through, above knee).
Age 18 years or older.

Exclusion Criteria

Unable to fill-in self-reported questionnaires (insufficiently reading or speaking the Dutch language, cognitive disorders, etc).
Life-expectancy less than 3 months.
Legally incompetent adults.

Study & Design

• Study Type: Observational non invasive
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The main endpoint is the functional ability and QoL of patients 6 months and<br /><br>one year after intervention (lower limb amputation or revascularization<br /><br>procedure). </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary endpoint is the assessment in terms of physiological and mobility<br /><br>parameters. </p><br>