NCT03570788

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
98

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Sep 2014

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 12, 2014

Completed
3.8 years until next milestone

First Submitted

Initial submission to the registry

June 13, 2018

Completed
14 days until next milestone

First Posted

Study publicly available on registry

June 27, 2018

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 20, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 20, 2019

Completed
Last Updated

June 28, 2019

Status Verified

June 1, 2019

Enrollment Period

4.7 years

First QC Date

June 13, 2018

Last Update Submit

June 27, 2019

Conditions

Quality of LifeAmputationPeripheral Arterial DiseaseProsthesis User

Outcome Measures

Primary Outcomes (1)

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

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

    1 year

Secondary Outcomes (1)

  • Proportion of patients using prosthesis

    1 year after the amputation

Interventions

AmputationPROCEDURE

Major amputation defined as at or above ankle

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Clinical Science and Education, Södersjukhuset, Karolinska Institutet

Stockholm, SE-118 83, Sweden

Location

MeSH Terms

Conditions

Peripheral Arterial Disease

Interventions

Amputation, Surgical

Condition Hierarchy (Ancestors)

AtherosclerosisArteriosclerosisArterial Occlusive DiseasesVascular DiseasesCardiovascular DiseasesPeripheral Vascular Diseases

Intervention Hierarchy (Ancestors)

Orthopedic ProceduresSurgical Procedures, Operative

Study Officials

  • Eva Torbjörnsson

    Department of Clinical Science and Education, Södersjukhuset, Karolinska Institutet

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Co - Principal Investigator, M.D Ph.D.

Study Record Dates

First Submitted

June 13, 2018

First Posted

June 27, 2018

Study Start

September 12, 2014

Primary Completion

May 20, 2019

Study Completion

May 20, 2019

Last Updated

June 28, 2019

Record last verified: 2019-06

Data Sharing

IPD Sharing
Will not share

Locations

SE(1)