Eneroth M, Larsson J, Oscarsson C, Apelqvist J
Department of Orthopaedics, Malmö University Hospital, Sweden.
J Wound Care. 2004 Jun;13(6):230-4. doi: 10.12968/jowc.2004.13.6.26627.
To determine if oral nutritional supplementation improved wound healing in malnourished patients with diabetic foot ulcers when compared with a placebo.
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.
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).
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.
与安慰剂相比，确定口服营养补充剂是否能改善营养不良的糖尿病足溃疡患者的伤口愈合情况。
这项前瞻性随机对照双盲试验纳入了年龄超过60岁、患有糖尿病且瓦格纳分级为I-II级、病程超过四周的足部溃疡患者。患者每天接受400毫升（400千卡）口服营养补充剂（n = 26）或400毫升安慰剂（n = 27），持续六个月。患者在六个月内每月随访一次，并在一年和两年后随访。
三分之一的患者在纳入时被归类为蛋白质能量营养不良，两组之间无差异。干预组严重下肢缺血比安慰剂组更常见（p = 0.008）。干预组有9名患者（35%）和安慰剂组有4名患者（15%）退出研究（无统计学意义）。在完成研究的患者中，23名接受安慰剂治疗的患者中有8名（41%）在六个月时伤口愈合，17名接受干预治疗的患者中有7名（35%）伤口愈合（无统计学意义）。纳入时患有蛋白质能量营养不良的患者中，24%在六个月时伤口愈合，而未患蛋白质能量营养不良的患者中这一比例为50%（无统计学意义）。
这是第一项评估营养补充剂对糖尿病足溃疡可能益处的研究。三分之一的患者营养不良。我们遇到了几个方法学问题，未能证明这些患者的伤口愈合率有所提高。
