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Clinical Trials/NCT03570788
NCT03570788
Completed
N/A

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

Jonas Malmstedt1 site in 1 country98 target enrollmentSeptember 12, 2014
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ConditionsQuality of LifeAmputationPeripheral Arterial DiseaseProsthesis User

Overview

Phase
N/A
Intervention
Not specified
Conditions
Quality of Life
Sponsor
Jonas Malmstedt
Enrollment
98
Locations
1
Primary Endpoint
Change in Health related quality of life according to EQ-5D
Status
Completed
Last Updated
6 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSitesSimilar Trials

Overview

Brief Summary

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

Registry
clinicaltrials.gov
Start Date
September 12, 2014
End Date
May 20, 2019
Last Updated
6 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Jonas Malmstedt
Responsible Party
Sponsor Investigator
Principal Investigator

Jonas Malmstedt

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

Karolinska Institutet

Eligibility Criteria

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)

Study Sites (1)

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