Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

HRQoL Among Patients Amputated Due to Peripheral Arterial Disease

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03570788
Recruitment Status : Completed
First Posted : June 27, 2018
Last Update Posted : June 28, 2019
Sponsor:
Information provided by (Responsible Party):
Jonas Malmstedt, Karolinska Institutet

Study Description
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
A prospective cohort study over the prosthetic use among patients amputated after vascular disease and the impact of their HRQoL.

Condition or disease Intervention/treatment
Quality of Life Amputation Peripheral Arterial Disease Prosthesis User Procedure: Amputation

Study Design
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Observational
Actual Enrollment : 98 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Health-related Quality of Life Among Patients Amputated Due to Peripheral Arterial Disease
Actual Study Start Date : September 12, 2014
Actual Primary Completion Date : May 20, 2019
Actual Study Completion Date : May 20, 2019

Resource links provided by the National Library of Medicine


Groups and Cohorts
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Intervention Details:
  • Procedure: Amputation
    Major amputation defined as at or above ankle

Outcome Measures
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. Proportion of patients using prosthesis [ Time Frame: 1 year after the amputation ]
    Prosthesis use after a major amputation is measured with Stanmore mobility grade


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
All patients amputated at Södersjukhuset during 2014-2018 are reviewed based on criteria for inclusion and exclusion. All patients that meets the inclusion criteria during the period will be contacted by the researcher in connection with the amputation and informed about the study.
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
Contacts and Locations
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03570788


Locations
Layout table for location information
Sweden
Department of Clinical Science and Education, Södersjukhuset, Karolinska Institutet
Stockholm, Sweden, SE-118 83
Sponsors and Collaborators
Jonas Malmstedt
Investigators
Layout table for investigator information
Principal Investigator: Eva Torbjörnsson Department of Clinical Science and Education, Södersjukhuset, Karolinska Institutet
More Information
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: Jonas Malmstedt, Co - Principal Investigator, M.D Ph.D., Karolinska Institutet
ClinicalTrials.gov Identifier: NCT03570788    
Other Study ID Numbers: 2014/801-31/1
First Posted: June 27, 2018    Key Record Dates
Last Update Posted: June 28, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Peripheral Arterial Disease
Peripheral Vascular Diseases
Atherosclerosis
Arteriosclerosis
 Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases