Feasibility and acceptability of the Smart Eating and Nutrition Supports solving Amputations, Toe loss and Exudate (SENSATE) Trial: protocol of a pilot study

Aims The aim of this pilot randomised controlled trial (RCT) is to evaluate feasibility and acceptability of a personalised medical nutrition therapy (MNT) intervention on wound healing in individuals with diabetes-related foot ulceration (DFU) attending high risk foot clinics in New South Wales.It's hypothesised that the personalised MNT intervention will be more acceptable and will improve diet quality compared to standard care.Methods A six week superiority pilot multicentre, parallel-group two arm RCT for individuals (n=40) with type 1 and 2 diabetes, living with active DFU classified as VL or L as per WIfI grading and recruited from two-high risk foot clinics.The primary outcome is feasibility and acceptability, assessed by a process evaluation.The intervention group will receive MNT delivered by a dietitian at baseline, and weeks 2 and 4, with nutrient-dense food boxes provided at MNT consultations.The control group will receive a healthy eating brochure.Both groups received standardised podiatry care. DiscussionThe results from this pilot study will enhance understanding of feasibility and acceptabilty of MNT for those with DFU and its potential for impact on wound healing.Results will inform future fully powered RCTs investigating effectiveness of MNT in individuals with DFU.