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

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

Status
Withdrawn
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02445170
Enrollment
0
Registered
2015-05-15
Start date
2015-07-31
Completion date
2015-12-31
Last updated
2016-08-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Amputees, Diabetes Complications

Keywords

Diabetes, amputation, below-knee, transmetatarsal, [M01.150.100], [C19.246.099]

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.

Interventions

PROCEDUREAmputation

Transmetatarsal or below-knee amputation

Sponsors

Helsinki University Central Hospital
Lead SponsorOTHER

Study design

Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Health-related quality of life measured by the HRQoL score2-5 years

Secondary

MeasureTime frame
The 15D health-related quality of life instrument2-5 years

Countries

Finland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026