Diabetes-related foot ulcers (DFUs) are a major complication of diabetes, with healing of these ulcers greatly influenced by nutrition.(1,2) While numerous studies have evaluated nutrient supplementation in those with DFU, limited research has explored the effectiveness of a dietitian providing personalised medical nutrition therapy (MNT) and food prescription.(2) Therefore, the primary aim was to assess the impact of personalised MNT, delivered by a dietitian, combined with medically tailored food packages (MTFPs) on diet quality in adults with DFU living in Australia. The secondary aims were to evaluate the feasibility and acceptability of the intervention, as well as the preliminary impact on weight and malnutrition status.
A six-week multi-centre pilot randomised controlled trial (RCT) was conducted in two-high risk foot clinics in Australia. Individuals with an active DFU classified as very low or low as per WIfI (Wound, Ischaemia, and Foot Infection), with an estimated glomerular filtration rate (eGFR) ≥60 mL/min and no signs of active osteomyelitis or Charcot neuroarthropathy were invited to participate. The intervention group received MNT counselling from a dietitian at baseline, week two and week four, and MTFPs provided at baseline and week four. The control received a general healthy eating brochure at baseline. Both groups received standard podiatry wound care and a $25 grocery voucher at each time-point. Preliminary effectiveness on diet quality was assessed using the Australian Eating Survey-Heart version at baseline and trial end. Intervention acceptability was measured using a process evaluation survey. Linear mixed-models with maximum likelihood estimation and robust confidence intervals were conducted for continuous variables, while McNemar’s test was utilised for categorical outcomes. The process evaluation was presented as counts.
A total of 15/17 consenting participants completed the trial. At baseline, the mean age was 60.8 years (SD 6.8), five female, and most were living with type 2 diabetes (n = 16/17). Significant between group differences were identified for protein, vitamin A and vitamin B12. Significant within group differences were found for the intervention group with an increase in energy, protein, fat, saturated fat, fibre, dairy serves, vitamin A and magnesium. While the intervention group had a significant increase in vitamin A from baseline to end of trial, the control group demonstrated a significant reduction in vitamin A from baseline to end of trial. The control group also demonstrated a significant reduction in vitamin B12 from baseline to end of trial. The process evaluation results showed that all participants agreed that the MNT and MTFPs interventions were acceptable.
This novel pilot RCT identified some improvements in diet quality favouring the intervention group, with the intervention deemed acceptable for those with DFU. Further research in a fully powered RCT of longer duration is warranted.