A Multifactorial intervention to improve cardiovascular outcomes in adults with type 2 diabetes and current or previous diabetes-related Foot ulcers - randomised controlled trial (MiFoot RCT)

niversity of Leicester0 sites392 target enrollmentSeptember 28, 2023

Overview

No summary available.

Registry

who.int

Start Date

September 28, 2023

End Date

December 31, 2026

Last Updated

last year

Study Type

Interventional

Sex

All

Sponsor

niversity of Leicester

•1\. Males and Females aged \>\= 18 years
•2\. Diagnosed with T2D
•3\. Current or previous DFUD (defined as diagnosed with DFUD in the previous 5 years)
•4\. Ability to speak and read English
•5\. Participant is able (in the Investigators opinion) and willing to fulfil all the study requirements
•6\. Currently not taking part in a CTIMP or any other disease management or lifestyle\-related intervention trial
•At the baseline visit, physical activity screening will be undertaken to assess safety considerations as a precaution prior to physical activity as part of the intervention. The participant may be excluded from the physical activity part of the intervention, but not the remaining intervention elements. Participants with both vascular and neuropathic ulcers will be eligible.

•1\. Diagnosed with other forms of diabetes (e.g., type 1 diabetes, monogenic diabetes (MODY), gestational diabetes or latent autoimmune diabetes in adults (LADA)
•2\. Other, non\-diabetic forms of ulceration (e.g., venous)
•3\. Serious illness or event with life\-expectancy \< 1 year or other significant illness which, in the opinion of a study clinician, precludes involvement
•4\. Planned major surgery
•5\. Requirement for renal replacement therapy
•6\. Current pregnancy, or actively trying to conceive
•7\. Unwilling or unable to give informed consent to participate in the study
•8\. Current participation in a CTIMP or any other disease management or lifestyle\-related intervention study (as determined by study investigator)
•9\. Unable to understand or read English
•Inability to participate in physical activity part of the intervention will not preclude inclusion in the study or the rest of the intervention, in order to represent the real\-world situation. We will collect data concerning this as part of the process evaluation (section 5\.2\.2\). The intervention will be delivered in English language and as such any participants who do not speak or read English to a sufficient standard will be excluded from the study. Every effort will be made to support participants with minimal English proficiency to participate.