HRQoL Among Patients Amputated Due to Peripheral Arterial Disease

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Quality of Life Amputation Arterial Occlusive Diseases Arteriosclerosis Atherosclerosis Cardiovascular Diseases Peripheral Arterial Disease Peripheral Vascular Diseases Prosthesis User Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Department of Clinical Science and Education, Södersjukhuset, Karolinska Institutet

Stockholm, SE-118 83, Sweden

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Amputation

Procedure

Major amputation defined as at or above ankle

Primary outcomes

Change in Health related quality of life according to EQ-5D

Time frame: 1 year

The change in HRQoL between baseline and after 1 year. Measured with EQ-5D-3L

Secondary outcomes

Proportion of patients using prosthesis

Time frame: 1 year after the amputation

Prosthesis use after a major amputation is measured with Stanmore mobility grade

Sponsors and collaborators

Lead sponsor

Jonas Malmstedt

Other

Registry information

Official study title

Health-related Quality of Life Among Patients Amputated Due to Peripheral Arterial Disease

Important dates

Study start: 2014
Primary completion: 2019
Study completion: 2019
First posted: Jun 27, 2018
Registry last updated: Jun 28, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed