{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,22]],"date-time":"2026-09-22T20:42:57Z","timestamp":1790109777024,"version":"4.0.1"},"reference-count":58,"publisher":"Mark Allen Group","issue":"6","content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["J Wound Care"],"published-print":{"date-parts":[[2004,6]]},"abstract":"<jats:sec><jats:title>Objective:<\/jats:title><jats:p> To determine if oral nutritional supplementation improved wound healing in malnourished patients with diabetic foot ulcers when compared with a placebo. <\/jats:p><\/jats:sec><jats:sec><jats:title>Method:<\/jats:title><jats:p> This prospective randomised controlled double-blind trial involved patients aged over 60 with diabetes mellitus and a Wagner grade I\u2013II foot ulcer of over four weeks\u2019 duration. Patients received either 400ml (400kcal) oral nutritional supplementation (n=26) or 400ml placebo (n=27) daily for six months. Patients were followed monthly for six months and after one and two years. <\/jats:p><\/jats:sec><jats:sec><jats:title>Results:<\/jats:title><jats:p> 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). <\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusion:<\/jats:title><jats:p> 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. <\/jats:p><\/jats:sec><jats:sec><jats:title>Declaration of interest:<\/jats:title><jats:p> This study was sponsored by a grant from Nutricia AB, Netherlands. <\/jats:p><\/jats:sec>","DOI":"10.12968\/jowc.2004.13.6.26627","type":"journal-article","created":{"date-parts":[[2014,5,23]],"date-time":"2014-05-23T15:58:19Z","timestamp":1400860699000},"page":"230-234","source":"Crossref","is-referenced-by-count":43,"title":["Nutritional supplementation for diabetic foot ulcers: the first RCT"],"prefix":"10.12968","volume":"13","author":[{"given":"M.","family":"Eneroth","sequence":"first","affiliation":[{"name":"Lund University Hospital, Sweden"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"J.","family":"Larsson","sequence":"additional","affiliation":[{"name":"Lund University Hospital, Sweden"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"C.","family":"Oscarsson","sequence":"additional","affiliation":[{"name":"Lund University Hospital, Sweden"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"J.","family":"Apelqvist","sequence":"additional","affiliation":[{"name":"Department of Endocrinology, Malm\u00f6 University Hospital, Sweden"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"5130","reference":[{"key":"p_9","volume-title":"Churchill Livingstone","author":"Frykberg R.G.","year":"1991"},{"key":"p_10","volume-title":"The Diabetic Foot","author":"Levin M.E.","year":"1993","edition":"5"},{"key":"p_11","volume-title":"The Foot in Diabetes","author":"Boulton A.J.M.","year":"1994","edition":"2"},{"key":"p_13","first-page":"81","volume":"66","author":"Towards","year":"1995","journal-title":"Acta Orthop Scand"},{"key":"p_14","doi-asserted-by":"publisher","DOI":"10.1016\/S0094-1298(02)00066-4"},{"key":"p_19","unstructured":"Serum albumin <35g\/l, serum transthyretin <0.2g\/l23-26and a total Iymphocyte count <1.5x109\/l were also used as markers of malnutrition.27,28"},{"key":"p_28","series-title":"Table 2","volume-title":"Apart from wound location, there was no difference between groups","author":"The"},{"key":"p_38","doi-asserted-by":"publisher","DOI":"10.1111\/j.1464-5491.1995.tb02078.x"},{"key":"p_39","doi-asserted-by":"publisher","DOI":"10.1007\/s001250051459"},{"key":"p_40","doi-asserted-by":"publisher","DOI":"10.2337\/diacare.24.1.78"},{"key":"p_41","doi-asserted-by":"publisher","DOI":"10.1177\/0148607186010006550"},{"key":"p_43","doi-asserted-by":"crossref","unstructured":"amputations. Clin Orthop 1987; 217: 253-256.","DOI":"10.1097\/00003086-198704000-00026"},{"key":"p_45","unstructured":"Disorders of Nutrition and Metabolism in Clinical Surgery. Churchill Livingstone, 1992. Outcome"},{"key":"p_55","unstructured":"Protein-energy malnutrition is common and often severe in hospitalised or institutionalised elderly subjects,31-36and in patients facing a major amputation because of vascular disease and\/or diabetes.17,18"},{"key":"p_56","unstructured":"Nutritional status and its relation to outcome in patients with diabetes and\/or ischaemia after amputations has been described in five studies,10,15-18all of which found a correlation between protein-energy malnutrition and a less favourable outcome. It is not known whether patients with diabetic foot ulcers are malnourished or would benefit from supplementary nutrition to promote wound healing. To our knowledge, this is the first study to evaluate the possible benefits of supplementary nutrition in these patients."},{"key":"p_61","unstructured":"Although the Mini Nutritional Assessment (MNA) seems to be the best available tool to identify protein-energy malnutrition in older people,35,39there is as yet no definitive test of nutritional status.40-44In the present study patients were classified as having protein-energy malnutrition if at least one nutritional parameter in at least two out of three groups (anthropometric measurements, serum proteins and total Iymphocyte count) were below a specific level."},{"key":"p_63","unstructured":"Although it is well established that protein-energy malnutrition increases the risk of delayed wound healing,9-14there are no guidelines on the type, extent or duration of nutritional supplementation for malnourished patients with wounds."},{"key":"p_64","unstructured":"We decided to give a daily oral supplementation of about 20-25% of the daily need for six months. Using this strategy we failed to show any effect of oral nutritional supplementation on wound healing and nutritional parameters."},{"key":"p_65","unstructured":"This may be due to several factors. Critical leg ischaemia was more common in the intervention group than in the placebo group. When subjects with critical leg ischaemia were excluded, the wound healing rate was significantly better in the intervention group, although the patient numbers were small. This supports previous findings that critical ischaemia is an important risk factor for non-healing and amputation once a foot ulcer or a deep infection has developed.45-47"},{"key":"p_72","first-page":"46","volume":"45","author":"Himes D","year":"1999","journal-title":"Ostomy Wound Manage"},{"key":"p_73","doi-asserted-by":"publisher","DOI":"10.12968\/jowc.2001.10.3.26058"},{"key":"p_74","doi-asserted-by":"publisher","DOI":"10.12968\/bjon.2001.10.Sup1.5336"},{"key":"p_75","doi-asserted-by":"publisher","DOI":"10.2106\/00004623-198466010-00011"},{"key":"p_76","doi-asserted-by":"publisher","DOI":"10.2106\/00004623-198668070-00013"},{"key":"p_78","first-page":"675","volume":"63","author":"Pedersen D","year":"1992","journal-title":"Acta Orthop Scand"},{"key":"p_80","doi-asserted-by":"publisher","DOI":"10.1007\/s002640050130"},{"key":"p_81","first-page":"185","volume":"6","author":"Turnbull P.J.","year":"2002","journal-title":"J Nutr Health Aging"},{"key":"p_82","doi-asserted-by":"publisher","DOI":"10.1177\/107110078100200202"},{"key":"p_83","doi-asserted-by":"publisher","DOI":"10.1016\/0261-5614(82)90015-2"},{"key":"p_85","doi-asserted-by":"publisher","DOI":"10.1093\/ageing\/19.2.131"},{"key":"p_86","doi-asserted-by":"publisher","DOI":"10.1016\/0261-5614(90)90017-M"},{"key":"p_88","first-page":"44","volume":"22","year":"1999","journal-title":"Clin Invest Med"},{"key":"p_89","doi-asserted-by":"publisher","DOI":"10.1515\/CCLM.2002.235"},{"key":"p_91","doi-asserted-by":"publisher","DOI":"10.1097\/00075197-200303000-00010"},{"key":"p_93","doi-asserted-by":"publisher","DOI":"10.1177\/014860717700100111"},{"key":"p_94","doi-asserted-by":"publisher","DOI":"10.1177\/0148607179003003157"},{"key":"p_95","doi-asserted-by":"publisher","DOI":"10.1016\/S0261-5614(98)80058-7"},{"key":"p_96","doi-asserted-by":"crossref","first-page":"55","DOI":"10.1016\/S0095-4543(21)00452-8","volume":"21","author":"Lipshitz D.A","year":"1996","journal-title":"Primary Care"},{"key":"p_98","volume-title":"Link\u00f6ping University","author":"Malnutrition","year":"1993"},{"key":"p_99","volume-title":"Proteinenergy malnutrition in chronic disease: clinical and immunological studies in elderly subjects with nonmalignant disorders. 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