None listed
Conditions
Brief summary
Diabetes-related foot ulcers (DFU) are a common and burdensome condition. Established interventions to promote DFU healing include local wound care, debridement, pressure offloading, management of infection and revascularisation. Despite this, the condition still accounts for significant morbidity and mortality in the community and further improvements in ulcer healing and overall outcomes in patients is essential. Recent studies have suggested that patients with type 2 diabetes mellitus are at risk of nutritional deficiencies due to high calorie yet low quality diets, poor food choices and/or restrictive eating (2). Nutrients such as Vitamin C (VitC), Vitamin A (VitA) and zinc are essential in wound healing by stimulating epithelialisation and cellular proliferation. Deficiencies in these micronutrients are common amongst people with diabetes and DFU but data regarding the effect of supplementation is limited. Our team is currently recruiting to a double-blinded randomised controlled trial of multivitamins in patients with chronic foot ulcers (VITAFOOT). However following minor amputations, patients are ineligible for recruitment for VITAFOOT, yet presumably are also at similar risk of micronutrient deficiencies. To complement VITAFOOT, in this pilot randomised controlled trial, we aim to recruit 100 adult patients at Fiona Stanley, Royal Perth, Sir Charles Gairdner or Albany Hospital with a DFU within 7 days of a minor amputation or debridement. Subjects can be either hospitalised or attending the outpatient high risk foot clinic. We will then compare 28 days of oral supplementation of VitC and zinc with placebo in a pilot randomised controlled trial. Subjects will be followed up at 4 and 12 weeks to assess wound healing, as measured using ARANZ Medical Silhouette™ wound measurement camera. Our primary outcome is to prove that micronutrient supplementation with VitC and zinc will result in greater reduction in wound area from baseline to 12 weeks (ie percentage change in wound area measured by Silhouette wound camera at 12 weeks). Secondary outcomes include: i) the percentage of completely healed DFUs at 12 weeks (ie percentage of patients with completely healed DFU at 12 weeks in intervention vs control group) ii) minor or major lower limb amputation or death at 12 weeks and iii) wound healing trajectory over 12 weeks (measured using total % area change from baseline). The following are not prespecified secondary outcomes but will also be reported i) baseline prevalence of VitC and zinc deficiencies in people with DFU, ii) adverse effects associated with micronutrient supplementation and placebo iv) baseline prevalence of anaemia, absolute iron deficiency and functional iron deficiency.
Interventions
Subjects allocated to the intervention arm will be administered oral capsules with Vitamin C 1000mg and Zinc picolinate 25mg daily for 28 days. Adherence will be monitored with a count of returned capsules at 28 days.
Sponsors
South Metropolitan Health Service - Fiona Stanley Fremantle Hospitals Group
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
i) Age greater than or equal to 18years ii) Diabetes (type 1 or 2) defined according to international consensus guidelines iii) Admission to Fiona Stanley Hospital, Royal Perth Hospital, Sir Charles Gairdner Hospital or Albany Hospital under the inpatient high-risk foot team service or attending outpatient clinic with a DFU. iv) Current inpatient admission or outpatient within 7 days of a minor amputation or debridement v) Competent and willing to provide informed consent vi) Able and willing to be followed up at 4 and 12 weeks
Exclusion criteria
i) Not competent to provide informed consent i.e. cognitive impairment, significant psychiatric illness, non-english speaking or other ii) Women of reproductive age i.e. less than 45 years iii) Already on VitC and/or zinc supplements or taken within 4 weeks of enrolment iv) Known VitC and/or zinc deficiencies v) Unlikely to be accessible for follow-up visit over the next 12 weeks
Outcome results
None listed