Heath-related Quality of Life of Diabetic Transmetatarsal Amputees and Below-knee Prosthetic Users

August 17, 2016 updated by: Jussi Repo, Helsinki University Central Hospital
The present study assesses the health-related quality of life of diabetic transmetatarstal and below-knee prosthetic user. The study design is cross-sectional with a retrospective review of patient hospital records and an assessment with patient-reported outcome measure.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Detailed Description

The present study aims to recruit 100 diabetic transmetatarsal and below-knee prosthetic user to assess the health-related quality of life (HRQoL) between these two patient groups. The 15D HRQoL instrument is applied. An additional comparison with the age-standardized Finnish general population will be performed.

Study Type

Observational

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Finland
    • Uusimaa
      • Helsinki, Uusimaa, Finland, 00029
        • Helsinki University Central Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Diabetic patients who underwent transmetatarsal amputaion or below-knee prosthetic users in a time frame of 2-5 years from the amputation.

Description

Inclusion Criteria:

  • Patients with diabetes
  • Transmetatarsal amputation
  • Below-knee prosthetic user
  • 2-5 years from surgery

Exclusion Criteria:

  • No diabetes
  • Other than transmetatarsal or below-knee amputation
  • Below-knee amputation but not a below-knee prosthetic user
  • Less than 2 years from the amputation
  • Over 5 years from amputation

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Below-knee amputees
The present group consists of diabetic below-knee prosthetic user
Procedure: Amputation
Transmetatarsal or below-knee amputation
Transmetatarsal amputees
The present group consists of diabetic transmetatarsal amputees
Procedure: Amputation
Transmetatarsal or below-knee amputation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Health-related quality of life measured by the HRQoL score
Time Frame: 2-5 years
2-5 years

Secondary Outcome Measures

Outcome Measure
Time Frame
The 15D health-related quality of life instrument
Time Frame: 2-5 years
2-5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Helsinki University Central Hospital

Investigators

  • Study Director: Erkki J Tukiainen, professor, Helsinki University Hospital and Helsinki University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2015

Primary Completion (Anticipated)

December 1, 2015

Study Completion (Anticipated)

December 1, 2015

Study Registration Dates

First Submitted

May 8, 2015

First Submitted That Met QC Criteria

May 12, 2015

First Posted (Estimate)

May 15, 2015

Study Record Updates

Last Update Posted (Estimate)

August 19, 2016

Last Update Submitted That Met QC Criteria

August 17, 2016

Last Verified

August 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 364/13/03/02/2014/8

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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