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

Diabetes Complications Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02445170
• Other study ID #: 364/13/03/02/2014/8
• Status: Withdrawn
• Phase: N/A
• First received: May 8, 2015
• Last updated: August 17, 2016
• Start date: July 2015
• Est. completion date: December 2015

Study information

• Verified date: August 2016
• Source: Helsinki University Central Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Finland: National Institute for Health and Welfare
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 2015
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Amputees
• Diabetes Complications

Intervention

Procedure:
• Amputation
Transmetatarsal or below-knee amputation

Locations

Country	Name	City	State
Finland	Helsinki University Central Hospital	Helsinki	Uusimaa

Sponsors (1)

Lead Sponsor	Collaborator
Helsinki University Central Hospital

Country where clinical trial is conducted

Finland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Health-related quality of life measured by the HRQoL score		2-5 years	No
Secondary	The 15D health-related quality of life instrument		2-5 years	No