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Clinical Trials/NCT03570788
NCT03570788CompletedNot Applicable

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

Jonas Malmstedt1 site in 1 country98 target enrollmentStarted: September 12, 2014Last updated:
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Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
98
Locations
1
Primary Endpoint
Change in Health related quality of life according to EQ-5D
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

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

Study Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Outcomes

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(1 year after the amputation)

Investigators

Sponsor
Jonas Malmstedt
Sponsor Class
Other
Responsible Party
Sponsor Investigator
Principal Investigator

Jonas Malmstedt

Co - Principal Investigator, M.D Ph.D.

Karolinska Institutet

Study Sites (1)

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