HRQoL Among Patients Amputated Due to Peripheral Arterial Disease

Completed

• Conditions: Quality of Life; Amputation; Prosthesis User; Peripheral Arterial Disease

• Registration Number: NCT03570788
• Lead Sponsor: Jonas Malmstedt

Brief Summary

A prospective cohort study over the prosthetic use among patients amputated after vascular disease and the impact of their HRQoL.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-09-12
• Study First Submitted: 2018-06-13
• Study First Submitted QC: 2018-06-25
• Study First Posted: 2018-06-27
• Primary Completion: 2019-05-20
• Study Completion: 2019-05-20
• Status Verified: 2019-06
• Last Update Submitted: 2019-06-27
• Last Update Posted: 2019-06-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 98

Inclusion Criteria

• Patients amputated at femoral, knee or tibial level due to peripheral arterial disease

Exclusion Criteria

• Patients not able to provide informed consent
• Patients not able to verbally express their experience of the amputation.
• Patients that not speak Swedish

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in Health related quality of life according to EQ-5D	1 year	The change in HRQoL between baseline and after 1 year. Measured with EQ-5D-3L

Secondary Outcome Measures

Name	Time	Method
Proportion of patients using prosthesis	1 year after the amputation	Prosthesis use after a major amputation is measured with Stanmore mobility grade

Trial Locations

Locations (1)

Department of Clinical Science and Education, Södersjukhuset, Karolinska Institutet; 🇸🇪 Stockholm, Sweden