SLR - May 2017 - Julie Riley

Effect of Oral Nutritional Supplementation on Wound Healing in Diabetic Foot Ulcers: A Prospective Randomized Controlled Trial

Reference: Armstrong DG1, Hanft JR, Driver VR, Smith AP, Lazaro-Martinez JL, Reyzelman AM, Furst GJ, Vayser DJ, Cervantes HL, Snyder RJ, Moore MF, May PE, Nelson JL, Baggs GE, Voss AC; Diabetic Foot Nutrition Study Group. Effect of Oral Nutritional Supplementation on Wound Healing in Diabetic Foot Ulcers: A Prospective Randomized Controlled Trial. Diabet Med. 2014 Sep;31(9):1069–77.

Scientific Literature Review

Reviewed By: Julie K. Riley, DPM
Residency Program: St. Elizabeth's Medical Center, Brighton, MA

Podiatric Relevance: A large part of many podiatric physicians’ practices includes treatment of patients living with diabetes and the complications associated with this complex disease, including wounds and pedal deformities. With the rise in obesity, poor nutrition and diabetes seen all over the world, it is important for physicians to have a large armamentarium of treatment modalities to combat these debilitating conditions. Aside from the more obvious factors, such as blood flow, infection and off-loading, another important factor is the nutritional status of our patients. In order to medically optimize a patient living with diabetes and a pedal wound, it is imperative to make sure s/he is well nourished and that s/he has the building blocks necessary to heal from the inside out. This study is relevant as it gives physicians another option to possibly help their patients heal, with just the simple addition of a supplemental drink.  

Methods: This study was a prospective, double-blinded, randomized, controlled, multicenter design. The study cohort consisted of patients living with diabetes and UT grade 1A diabetic foot ulcers. The authors’ goal was to compare healing rates of the ulcers in patients receiving a supplement made up of arginine, glutamine and beta-hydroxy-beta methyl-butyrate, versus a control group receiving a placebo. Patients received a supplement drink or a calorically similar control drink twice a day for 16 weeks. Subjects were examined weekly throughout the study. The primary endpoint was complete epithelialization of the wound without drainage indicating total wound closure. Secondary endpoints included reduction in size of the wound at one week, four weeks, change in area, quality of life and incidence of complications, such as infection or additional ulcerations. The data was assessed to determine statistically significant outcomes, as indicated by a one-sided P value of less than 0.025 for coprimary outcomes and a two-sided P value of 0.05 for a posthoc analyses.

Results: A total of 1,052 patients were screened for the study, and 271 patients were randomized. The end results were based off of 105 patients in the supplement group and 102 patients in the control group. At 16 weeks, there were no statistically significant differences for either primary or secondary outcomes in the control versus supplement groups. A posthoc analysis revealed that patients with a baseline albumin level less than or equal to 40 g/l, an ABI less than 1.00, or both, had a significantly greater percentage of total wound healing at 16 weeks if they were given the supplement versus the control.

Markers of nutrition, such as albumin and prealbumin, although not specific, can lend some insight into a patient's overall nutritional status. Protein and amino acids are important building blocks our bodies need to heal wounds. Amino acids that are utilized in tissue repair, collagen synthesis and cell group can become essential at times when our bodies are under stress. Although this study did not reveal any significant difference between the supplement versus control groups, it showed that there may be a role for supplementation in patients who have subpar nutrition or vascular status at baseline. The complexity of this population of patients continues to pose a challenge to physicians worldwide. This study highlights the need for further investigation into nutritional supplementation to optimize wound healing and aims to increase the awareness of treatment modalities that may not have been thought of before. 

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