Nutritional supplementation for diabetic foot ulcers: the first RCT

Abstract

Objective: To determine if oral nutritional supplementation improved wound healing in malnourished patients with diabetic foot ulcers when compared with a placebo.

Method: This prospective randomised controlled double-blind trial involved patients aged over 60 with diabetes mellitus and a Wagner grade I-II foot ulcer of over four weeks' duration. Patients received either 400 ml (400 kcal) oral nutritional supplementation (n = 26) or 400 ml placebo (n = 27) daily for six months. Patients were followed monthly for six months and after one and two years.

Results: A third of the patients were classified as having protein-energy malnutrition at inclusion, with no difference between the two groups. Critical leg ischaemia was more common in the intervention group than in the placebo group (p = 0.008). Nine patients in the intervention group (35%) and four in the placebo group (15%) dropped out of the study (not significant). Of those who completed the study, the wound had healed at six months in eight out of 23 patients (41%) (placebo) and in seven out of 17 (35%) (intervention) (not significant). Twenty-four per cent of patients with protein-energy malnutrition at inclusion had healed at six months compared with 50% of those without it (not significant).

Conclusion: This is the first study to evaluate the possible benefits of nutritional supplementation on diabetic foot ulcers. A third of patients were malnourished. We encountered several methodological problems and were unable to demonstrate an improved wound healing rate in these patients.