Influence of Diabetes on Lower Limb Amputation
|ClinicalTrials.gov Identifier: NCT02500303|
Recruitment Status : Unknown
Verified January 2018 by Fiona Smith, University of Glasgow.
Recruitment status was: Active, not recruiting
First Posted : July 16, 2015
Last Update Posted : January 26, 2018
|Condition or disease|
This research has been designed to ask the following question: What are the factors that influence the rehabilitation and functional outcomes following LEA, in the long term in both those with and without diabetes.
Therefore this study will be a prospective observational analysis of all those who undergo a LEA in one year within the Greater Glasgow & Clyde area with follow up at 6, 12 & 18 months from date of amputation.
- Primary Endpoint Comparison of rehabilitation and functional outcomes in those with diabetes to those without diabetes, up to 18 months post LEA.
- At discharge from rehabilitation, the characteristics of those who proceed to limb fitting following LEA to those who do not will be defined.
- At discharge from rehabilitation, the characteristics of those with diabetes that do not proceed to limb fitting following LEA compared to those who do.
- At discharge from rehabilitation to 18 months post LEA, a comparison of the characteristics in those with and without diabetes.
- From six months post LEA, at 6 monthly intervals (6,12 & 18 months), a comparison of the health status, social circumstances, mobility and quality of life measures in those with and without diabetes.
|Study Type :||Observational [Patient Registry]|
|Estimated Enrollment :||171 participants|
|Target Follow-Up Duration:||5 Years|
|Official Title:||Rehabilitation & Function Following Lower Limb Amputation: the Influence of Diabetes|
|Actual Study Start Date :||March 2014|
|Estimated Primary Completion Date :||December 2018|
|Estimated Study Completion Date :||December 2018|
- Mortality [ Time Frame: 3 years ]Date of Death if applicable
- Limb fitting [ Time Frame: 3 years ]Dtae of receiving prosthetic limb
- Length of stay [ Time Frame: 3 years ]Length of time in hospital as an in patient
- Readmission [ Time Frame: 3 years ]Date of readmission to hospital
- Further surgery [ Time Frame: 3 years ]Number and level of further amputations
- EQ-5D-5L [ Time Frame: 3 years ]Quality of life measure
- Reintegration to normal living index [ Time Frame: 3 years ]
- Prosthetic Limb User Mobility [ Time Frame: 3 years ]As assessed by the prosthetic limb user survey mobility scale
- Co-morbidities [ Time Frame: 3 years ]Functional co-morbidity index
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02500303
|Glasgow, United Kingdom, G11 6NT|
|Study Director:||Lorna Paul, PhD||University of Glasgow|