Influence of Diabetes on Lower Limb Amputation

• Conditions: Diabetes; PAD

• Registration Number: NCT02500303
• Lead Sponsor: University of Glasgow

Brief Summary

The purpose of this study is to explore the factors that influence limb fitting in those with diabetes compared to those without diabetes. The population without diabetes will usually present with peripheral arterial disease (PAD) and are similar in management following LEA. The impact that not walking with a prosthesis has long term on both populations will be explored. In general, previous research has used retrospective analysis of case notes which, although valuable, have fixed fields and only allow the researcher to look at associations between factors not at causation. Additionally, very few have followed a population over time. Therefore this study will be a prospective observational analysis of all those who undergo a LEA in one year from 01/03/14 to 28/02/15 within the Greater Glasgow \& Clyde area with follow up at 6, 12 \& 18 months from date of amputation.

Detailed Description

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.

* Secondary endpoints

1. At discharge from rehabilitation, the characteristics of those who proceed to limb fitting following LEA to those who do not will be defined.

2. At discharge from rehabilitation, the characteristics of those with diabetes that do not proceed to limb fitting following LEA compared to those who do.

3. At discharge from rehabilitation to 18 months post LEA, a comparison of the characteristics in those with and without diabetes.

4. 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 Timeline

• Study Start: 2014-03
• Study First Submitted: 2014-12-02
• Study First Submitted QC: 2015-07-15
• Study First Posted: 2015-07-16
• Status Verified: 2018-01
• Last Update Submitted: 2018-01-25
• Last Update Posted: 2018-01-26
• Primary Completion: 2018-12
• Study Completion: 2018-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 171

Inclusion Criteria

• Over 18 years of age with a major amputation above the ankle.

Exclusion Criteria

• Amputation for tumour, trauma, congenital abnormalities
• Amputation at hip disarticulation or trans-pelvectomy level
• Adults with incapacity

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Mortality	3 years	Date of Death if applicable
Readmission	3 years	Date of readmission to hospital
Limb fitting	3 years	Dtae of receiving prosthetic limb
Length of stay	3 years	Length of time in hospital as an in patient
Further surgery	3 years	Number and level of further amputations

Secondary Outcome Measures

Name	Time	Method
Co-morbidities	3 years	Functional co-morbidity index
EQ-5D-5L	3 years	Quality of life measure
Reintegration to normal living index	3 years
Prosthetic Limb User Mobility	3 years	As assessed by the prosthetic limb user survey mobility scale

Trial Locations

Locations (1)

Western Infirmary; 🇬🇧 Glasgow, United Kingdom