VITA-AMP - a pilot randomised controlled trial of vitamin supplementation in people following diabetes-related minor amputation of the lower limb.

Category Primary study
Registry of TrialsANZCTR
Year 2023
INTERVENTION: Subjects allocated to the intervention arm will be administered oral capsules with Vitamin C 1000mg, Zinc picolinate 25mg and Vitamin A 750mcg/2500IU daily for 28 days. Adherence will be monitored with a count of returned capsules at 28 days. CONDITION: Diabetes‐related foot disease; ; Diabetes‐related foot disease Metabolic and Endocrine ‐ Diabetes PRIMARY OUTCOME: Percentage change in wound area measured by Silhouette from baseline to 12 weeks.[12 weeks from initiating treatment] SECONDARY OUTCOME: A composite outcome of any of the following: minor limb amputation, major limb amputation or death within 12 weeks from clinical assessment and audit of hospital records[12 weeks from initiating treatment] Proportion of completely healed DFUs at 12 weeks by clinical assessment.[At conclusion of study] 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
Epistemonikos ID: c6653f5a040b5fdc8ae31d43854e401cba3c1861
First added on: Feb 20, 2024