Heath-related Quality of Life of Diabetic Transmetatarsal Amputees and Below-knee Prosthetic Users
Withdrawn
- Conditions
- AmputeesDiabetes Complications
- Interventions
- Procedure: Amputation
- Registration Number
- NCT02445170
- Lead Sponsor
- Helsinki University Central Hospital
- Brief 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.
- 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.
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- All
- Target Recruitment
- Not specified
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
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Transmetatarsal amputees Amputation The present group consists of diabetic transmetatarsal amputees Below-knee amputees Amputation The present group consists of diabetic below-knee prosthetic user
- Primary Outcome Measures
Name Time Method Health-related quality of life measured by the HRQoL score 2-5 years
- Secondary Outcome Measures
Name Time Method The 15D health-related quality of life instrument 2-5 years
Trial Locations
- Locations (1)
Helsinki University Central Hospital
🇫🇮Helsinki, Uusimaa, Finland