Khirurgiia · 2018
[Efficacy and safety of collagen biomaterial local application in complex treatment of the diabetic foot syndrome (final results of the multicenter randomised study)].
СтатьяМногоцентровое исследованиеРандомизированное исследованиеНазвание и аннотация: Оригинал на русском
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Stupin V A, Silina E V, Gorskij V A, Gorjunov S V, Zhidkih S Yu, Komarov A N, Sivkov A S, Gabitov R B, Zolotareva L S, Sinel'nikova T G, Barancevich E R, Bogomolov M S, Korejba K A, Bogdanov E A, Krivihin V E, Bakunov M Yu, Eliseeva M E, Krivihin D V
Аннотация
AIM: To evaluate the efficacy and safety of collagen biomaterial application during the 4-week follow-up of patients with diabetic foot syndrome.
MATERIAL AND METHODS: 75 patients with diabetic foot (Wagner II (69.3%) and III (30.7%)) aged 30-80 years were included in the multicenter study, among them were 50.7% with the wound unhealed for 1.5-6 months and 49.3% over 6-48 months. Patients were randomized into 2 groups: 1) standard therapy (n=37), 2) the additional use of the collagen material Collost (n=38). Observation period was at least 4 weeks for each patient. The size of ulcers, results of general and biochemical blood tests, oximetry, microbiological testing, ultrasound of lower extremities vessels as well as a detailed medical history, social and functional status, level of cardiovascular comorbidity and ongoing therapy were estimated.
RESULTS: Additional use of a collagen biomaterial has led to a significant reduction ulcers of all sizes from 13.5 to 2.1 cm2 (in the comparison group - from 12.5 to 7 cm2). The best dynamics have been registered in Wagner II (4.4-fold average wound area regress in Collost group, from 8.8 to 2.0 cm2; average wound area regress by 1.8 times, from 10 to 5.6 cm2 in the comparison group) than in Wagner III group (in the main group from 55 to 21.3 cm2; in the control group from 36 to 32.4 cm2) and in ulcers existing less than 6 months. Treatment with biological material Collost within standard therapy after 4 weeks led to increase of complete epithelialization by 2.6% (21.1% as compared to 14.7%), while decreasing the frequency of ineffective treatment by 4.1 (7.9% in primary and 32.4% in the comparison group).
CONCLUSION: We have proved the efficacy and safety of collagen biomaterial topical application in a diabetic foot syndrome treatment.
MATERIAL AND METHODS: 75 patients with diabetic foot (Wagner II (69.3%) and III (30.7%)) aged 30-80 years were included in the multicenter study, among them were 50.7% with the wound unhealed for 1.5-6 months and 49.3% over 6-48 months. Patients were randomized into 2 groups: 1) standard therapy (n=37), 2) the additional use of the collagen material Collost (n=38). Observation period was at least 4 weeks for each patient. The size of ulcers, results of general and biochemical blood tests, oximetry, microbiological testing, ultrasound of lower extremities vessels as well as a detailed medical history, social and functional status, level of cardiovascular comorbidity and ongoing therapy were estimated.
RESULTS: Additional use of a collagen biomaterial has led to a significant reduction ulcers of all sizes from 13.5 to 2.1 cm2 (in the comparison group - from 12.5 to 7 cm2). The best dynamics have been registered in Wagner II (4.4-fold average wound area regress in Collost group, from 8.8 to 2.0 cm2; average wound area regress by 1.8 times, from 10 to 5.6 cm2 in the comparison group) than in Wagner III group (in the main group from 55 to 21.3 cm2; in the control group from 36 to 32.4 cm2) and in ulcers existing less than 6 months. Treatment with biological material Collost within standard therapy after 4 weeks led to increase of complete epithelialization by 2.6% (21.1% as compared to 14.7%), while decreasing the frequency of ineffective treatment by 4.1 (7.9% in primary and 32.4% in the comparison group).
CONCLUSION: We have proved the efficacy and safety of collagen biomaterial topical application in a diabetic foot syndrome treatment.