Khirurgiia (Mosk). 2026;(11):85-94. doi: 10.17116/hirurgia202611185.
ABSTRACT
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.
PMID:43024528 | DOI:10.17116/hirurgia202611185
