SENSATE trial: Smart Eating and Nutrition Supports solving Amputations, Toe loss and Exudate.

Not Applicable

Recruiting

• Conditions: Diabetes-related foot ulcer; Metabolic and Endocrine - Diabetes; Diet and Nutrition - Other diet and nutrition disorders

• Registration Number: ACTRN12623001111662
• Lead Sponsor: niversity of Newcastle

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2023-10-25
• Last Update Posted: 15 April 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

Inclusion criteria for the study will include:
• individuals aged 18 years and over;
•type 1 or 2 diabetes mellitus, with an active foot ulceration classified VL or L as per WIfI grading;
•previous amputation;
•stage 1 or 2 chronic kidney disease;
•and the ability to provide written informed consent;
•Those on active weekly insulin titration will be included and participants must be willing to attend each visit to the high-risk foot clinic;
•Those taking oral nutrition supplements or vitamin/mineral supplements will be asked to ensure the dose is kept stable and exactly the same for the duration of the study.

Exclusion Criteria

Exclusion criteria for the study will include:
•foot ulceration classified as M or H as per WIfI;
•current acute osteomyelitis or active Charcot neuroarthropathy;
•malabsorptive background (bariatric surgery and inflammatory bowel disease);
•currently receiving dietetic support/intervention;
•those will food allergies/intolerances;
•history of cognitive disorders impacting their ability to consent or communicate effectively;
•stage 3-5 chronic kidney disease or on dialysis;
•pregnant or breastfeeding;
•In addition, those with a heel wound will be excluded due to the nature of a heel wound being more difficult to manage, worse predicted outcomes and to ensure a homogenous sample for the trial.

Study & Design

• Study Type: Interventional
• Study Design: Not specified