Influence of Diabetes on Lower Limb Amputation

Diabetes Clinical Trial

Official title:

Rehabilitation & Function Following Lower Limb Amputation: the Influence of Diabetes

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02500303
• Other study ID #: GN13DI563
• Status: Active, not recruiting
• Phase: N/A
• First received: December 2, 2014
• Last updated: January 25, 2018
• Start date: March 2014
• Est. completion date: December 2018

Study information

• Verified date: January 2018
• Source: University of Glasgow
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 171
• Est. completion date: December 2018
• Est. primary completion date: December 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Diabetes
• Diabetes Mellitus
• PAD

Locations

Country	Name	City	State
United Kingdom	Western Infirmary	Glasgow

Sponsors (2)

Lead Sponsor	Collaborator
University of Glasgow	NHS GG&C

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mortality	Date of Death if applicable	3 years
Primary	Limb fitting	Dtae of receiving prosthetic limb	3 years
Primary	Length of stay	Length of time in hospital as an in patient	3 years
Primary	Readmission	Date of readmission to hospital	3 years
Primary	Further surgery	Number and level of further amputations	3 years
Secondary	EQ-5D-5L	Quality of life measure	3 years
Secondary	Reintegration to normal living index		3 years
Secondary	Prosthetic Limb User Mobility	As assessed by the prosthetic limb user survey mobility scale	3 years
Secondary	Co-morbidities	Functional co-morbidity index	3 years