Influence of Diabetes on Lower Limb Amputation

Status Active, not recruiting

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.

Clinical Trial 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 Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT02500303
Study type	Observational [Patient Registry]
Source	University of Glasgow
Contact
Status	Active, not recruiting
Phase	N/A
Start date	March 2014
Completion date	December 2018

View Details

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.