None listed
Conditions
Brief summary
Diabetes-related foot ulceration (DFU) affects 56,000 Australians yearly, with one person every hour undergoing a foot/leg amputation. DFU healing is complex and multi-factorial. Our research is focused on diets in DFU healing, which is currently under-researched and highly topical. The research team have added to the literature significantly, demonstrating Australian Adults with DFU have poor quality and variety of dietary intake, have micronutrient deficiencies, and individuals with DFU taking supplementation have significantly increased likelihood of healing. However, we do not currently understand best nutrition intervention to support wound healing in those with diabetes. Therefore, this trail was co-designed with people with DFU and wound clinicians to increase acceptability and feasibility. We propose a a 6-week superiority pilot multicentre, double blinded, parallel-group randomised controlled trial that will determine if a personalised dietary intervention in combination with a food box improves wound healing in those living with a DFU.
Interventions
Participants in the intervention group will be provided one initial dietitian consult (duration of 30 minutes) and 2 review sessions (30 minutes) with the dietitian. The consultations will be one-on-one and face-to-face with the dietitian following their podiatry appointment. The initial consult will be conducted during week 1 of the intervention phase, with the review sessions occurring on week’s 2 and week 4. The dietitian consults will include personalised Medical Nutrition Therapy (MNT) comb
Participants in the intervention group will be provided one initial dietitian consult (duration of 30 minutes) and 2 review sessions (30 minutes) with the dietitian. The consultations will be one-on-one and face-to-face with the dietitian following their podiatry appointment. The initial consult will be conducted during week 1 of the intervention phase, with the review sessions occurring on week’s 2 and week 4. The dietitian consults will include personalised Medical Nutrition Therapy (MNT) combined with motivational interviewing (Capabilities, Opportunities, Motivation and Behaviour model (COMB-B model) and the Personalised Nutrition Questionnaire (PNQ)). The Academy of Nutrition and Dietetics reports MNT refers to the evidence-based use of the Nutrition Care Process (nutrition assessment, nutrition diagnosis, nutrition intervention, and nutrition monitoring and evaluation) which typically results in prevention, delayed progression or management of diseases/conditions. The intervention group will also receive 2 food boxes containing food important for wound healing at baseline (1 box) and week 4 (1 box), and a $25 voucher at baseline, week 2, week 4 and week 6 at their podiatry appointment to compensate them for their time and assist with food costs. All participants will be provided standardised podiatry care which will include debridement, wound dressing and pressure offloading (standard care). To monitor adherence to the intervention, we will review and extract data required out of medical records.
Sponsors
University of Newcastle
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
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.
Outcome results
None listed