Off-Label Use of Neovasculgen for II–III Degree Foot Frostbite: A Case Report

INTRODUCTION. The high mortality and disability rates associated with cold injury are often a consequence of urgent amputation or disarticulation surgery. The use of the Russian gene therapy product Neovasculgen can decrease the amputation rate in patients with chronic limb ischaemia through preventing the progression of endothelial dysfunction and stimulating tissue revascularisation. The mechanism of action of Neovasculgen indicates its potential as an initial treatment option for patients presenting with frostbite and progressive tissue ischaemia. CASE REPORT . In January 2024, a 42-year-old male with secondto third-degree frostbite and threatened amputation of the left big toe was admitted to the burn unit at the V.K. Gusak Institute of Urgent and Recovery Surgery. Upon medical board consultation with specialty physicians and a clinical pharmacologist, the patient was prescribed off-label treatment with Neovasculgen. This was the first experience of using Neovasculgen in complex frostbite therapy of a patient in critical condition. The patient received periarterial injections of the medicinal product in the middle third of his left calf at a dose of 1.2 mg (at a 1:20 dilution with water for injection) on days 6 and 14 from the cold injury. The procedure was guided by Doppler ultrasonography of the calf vessels. After 2 days from the first injection, the patient experienced positive changes, including warming of the skin over the distal area of his left foot and a decrease in pain severity. After 5 days, the patient demonstrated a decrease in oedema and cyanosis of the toes, an increase in the active and passive range of toe motion, and an improvement in the supporting function of the foot. On day 15, the patient was discharged from the hospital in good condition. He had no pain or paraesthesia in his foot, and its weight-bearing ability and active and passive range of motion were fully restored. CONCLUSION. This outcome offers a potential way to improve the medical care available to patients with cold injury: Neovasculgen integration into complex frostbite therapy provides an opportunity to shorten hospitalisation and rehabilitation periods and reduce the risk of disability. However, a systematic analysis and validation of clinical efficacy and safety data and a cost-benefit analysis are needed to confirm the feasibility of cold injury treatment with Neovasculgen.