Effect of nutritional support on postoperative period in diabetic patients with protein and energy deficiency after limb amputation

Objective. To analyze efficacy and safety of postoperative nutritional support using LEOVIT PHARMA therapeutic enteral nutrition in patients with diabetes mellitus after limb amputation. Material and methods. A prospective randomized study included 119 patients (80 in the study group and 39 in the control group) with type 2 diabetes mellitus (DM2). All patients signed an informed consent to participate in clinical study. Inclusion criteria: patient consent to participate; age over 18 years; primary diagnosis of DM2, diabetic angiopathy, and lower-limb gangrene; surgical intervention involving amputation of thigh, lower leg or toes; mild, moderate, or severe protein-energy malnutrition; ECOG score > 2—3; PG-SGA score ≥ 9. Exclusion criteria: patient refusal to participate at any stage; allergic or adverse reactions at any stage; severe mental illness. Patients were assigned to groups using a cluster method (ratio 2:1). Regarding nutritional support regimen, patients in the study group were prescribed LEOVIT PHARMA enteral nutrition according to the manufacturer’s protocol. For the first 3 days prior to surgery, patients received a restorative protein shake (one single-serving packet, 4 times daily). Postoperatively, they received a detoxifying protein shake for subsequent 6 days (4 times daily). Patients received LEOVIT PHARMA protein shake for a total of 9 days. Patients in the second group received standard enteral nutrition. Preoperative nutritional management relied primarily on standard low-calorie diet, while postoperative regimen consisted of a gentle (bland) diet. Results. A new oral nutritional supplement (sipping formula) facilitated reparative processes at the surgical site. Microscopic analysis of wound exudate revealed a shortened alteration phase of healing process and rapid onset of reparative phase. Specifically, regenerative-degenerative index in the study group in early postoperative period was 16.3—21.2% higher than in the control group (p<0.05). Studies noted a relatively rapid transformation of polyblasts into connective tissue cells. Sipping therapy using specialized LEOVIT PHARMA enteral formulas was associated with a 17.6% reduction in total number of complications (χ²=2.78, p=0.041). Conclusion. This prospective randomized study demonstrates that LEOVIT PHARMA enteral nutrition product for patients with type 2 diabetes mellitus undergoing amputation is a highly effective and safe therapeutic component.