Pilot study of the safety and efficacy of angiogenic therapy in diabetic foot syndrome

BACKGROUND: The syndrome of diabetic foot remains the main cause of non-traumatic amputation of the lower extremity in the world. Even with the provision of comprehensive medical care in the conditions of a specialized center, 10-15% of patients do not succeed in healing the ulcerative defect due to...

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Autores principales:	Igor L. Plaksa, Nina D. Mzhavanadze, Roman E. Kalinin, Igor A. Suchkov, Michail U. Bakunov, Vyacheslav T. Krivichin, Sergey A. Matveev, Artur A. Isaev, Roman V. Deev
Formato:	article
Lenguaje:	EN RU
Publicado:	Endocrinology Research Centre 2019
Materias:	diabetic foot syndrome therapeutic angiogenesis pl-vegf165 Nutritional diseases. Deficiency diseases RC620-627
Acceso en línea:	https://doaj.org/article/10ea3aa93c384104a861a4d47aaf033e
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spelling	oai:doaj.org-article:10ea3aa93c384104a861a4d47aaf033e2021-11-14T09:00:22ZPilot study of the safety and efficacy of angiogenic therapy in diabetic foot syndrome2072-03512072-037810.14341/DM9644https://doaj.org/article/10ea3aa93c384104a861a4d47aaf033e2019-12-01T00:00:00Zhttps://www.dia-endojournals.ru/jour/article/view/9644https://doaj.org/toc/2072-0351https://doaj.org/toc/2072-0378BACKGROUND: The syndrome of diabetic foot remains the main cause of non-traumatic amputation of the lower extremity in the world. Even with the provision of comprehensive medical care in the conditions of a specialized center, 10-15% of patients do not succeed in healing the ulcerative defect due to the ischemic component. AIMS: The objective of this study is evaluation of safety and efficacy of pl-VEGF165 transfer in patients with neuroischemic type of diabetic foot syndrome. METHODS: The pilot study included 35 diabetic patients with neuroischemic foot ulcers (Wagner stage 1-2) who were not candidates for revascularization procedures (NCT02538705). The patients were closely monitored after repeated pl-VEGF165 intramuscular gene transfer (2,4 mg) at 1, 3, and 6 months after treatment. The primary efficacy endpoint was the surface area of the ulcers (sq.cm), the secondary endpoints were transcutaneous oxygen tension (Tcp02), ankle-brachial index (ABI), neuropathy disability score (NDS), neuropathy symptoms score (NSS), and Michigan neuropathy screening instrument (MNSI). Adverse events were monitored throughout the study. RESULTS: The use of pl-VEGF165 as part of complex treatment allowed to achieve wound healing in 65,7% of patients with chronic ulcerative defects, the safety of the target limb was 84%. Carrying out therapeutic angiogenesis as a part of the combined therapy ensured a reduction in the average area of the resistant to treatment defects from 3.6 [1.0; 7.05] cm2 to 0.0 [0.0;2.0] cm2 (p=0,001), which correlated with an increase in the TcPo2 index by 15% from 35 [29.5; 40.5] to 40.5 [36.0; 46.5] mm Hg (p= p=0,005) and in the ABI by 16% from 0.96 [0.82;1.08] to 1.11 [0.85; 1.24] (p=0,062). The decrease in the signs of diabetic neuropathy was determined - the scores of NSS scales and VAT decreased from 6,5 [5.75; 8.0) to 6.0 [5.25; 7.0] (p=0,004) and from 9.0 [8.0; 13.5] to 8.0 [7.0; 12.7] (p=0,001), respectively. No adverse effects associated with the use of pl-VEGF165 were recorded. CONCLUSIONS: Thus, preliminary results of the pilot study show that the use of pl-VEGF165 gene transfer in combination therapy allows for complete healing of neuroischemic diabetic foot ulcers in the majority of patients.Igor L. PlaksaNina D. MzhavanadzeRoman E. KalininIgor A. SuchkovMichail U. BakunovVyacheslav T. KrivichinSergey A. MatveevArtur A. IsaevRoman V. DeevEndocrinology Research Centrearticlediabetic foot syndrometherapeutic angiogenesispl-vegf165Nutritional diseases. Deficiency diseasesRC620-627ENRUСахарный диабет, Vol 22, Iss 6, Pp 559-567 (2019)
institution	DOAJ
collection	DOAJ
language	EN RU
topic	diabetic foot syndrome therapeutic angiogenesis pl-vegf165 Nutritional diseases. Deficiency diseases RC620-627
spellingShingle	diabetic foot syndrome therapeutic angiogenesis pl-vegf165 Nutritional diseases. Deficiency diseases RC620-627 Igor L. Plaksa Nina D. Mzhavanadze Roman E. Kalinin Igor A. Suchkov Michail U. Bakunov Vyacheslav T. Krivichin Sergey A. Matveev Artur A. Isaev Roman V. Deev Pilot study of the safety and efficacy of angiogenic therapy in diabetic foot syndrome
description	BACKGROUND: The syndrome of diabetic foot remains the main cause of non-traumatic amputation of the lower extremity in the world. Even with the provision of comprehensive medical care in the conditions of a specialized center, 10-15% of patients do not succeed in healing the ulcerative defect due to the ischemic component. AIMS: The objective of this study is evaluation of safety and efficacy of pl-VEGF165 transfer in patients with neuroischemic type of diabetic foot syndrome. METHODS: The pilot study included 35 diabetic patients with neuroischemic foot ulcers (Wagner stage 1-2) who were not candidates for revascularization procedures (NCT02538705). The patients were closely monitored after repeated pl-VEGF165 intramuscular gene transfer (2,4 mg) at 1, 3, and 6 months after treatment. The primary efficacy endpoint was the surface area of the ulcers (sq.cm), the secondary endpoints were transcutaneous oxygen tension (Tcp02), ankle-brachial index (ABI), neuropathy disability score (NDS), neuropathy symptoms score (NSS), and Michigan neuropathy screening instrument (MNSI). Adverse events were monitored throughout the study. RESULTS: The use of pl-VEGF165 as part of complex treatment allowed to achieve wound healing in 65,7% of patients with chronic ulcerative defects, the safety of the target limb was 84%. Carrying out therapeutic angiogenesis as a part of the combined therapy ensured a reduction in the average area of the resistant to treatment defects from 3.6 [1.0; 7.05] cm2 to 0.0 [0.0;2.0] cm2 (p=0,001), which correlated with an increase in the TcPo2 index by 15% from 35 [29.5; 40.5] to 40.5 [36.0; 46.5] mm Hg (p= p=0,005) and in the ABI by 16% from 0.96 [0.82;1.08] to 1.11 [0.85; 1.24] (p=0,062). The decrease in the signs of diabetic neuropathy was determined - the scores of NSS scales and VAT decreased from 6,5 [5.75; 8.0) to 6.0 [5.25; 7.0] (p=0,004) and from 9.0 [8.0; 13.5] to 8.0 [7.0; 12.7] (p=0,001), respectively. No adverse effects associated with the use of pl-VEGF165 were recorded. CONCLUSIONS: Thus, preliminary results of the pilot study show that the use of pl-VEGF165 gene transfer in combination therapy allows for complete healing of neuroischemic diabetic foot ulcers in the majority of patients.
format	article
author	Igor L. Plaksa Nina D. Mzhavanadze Roman E. Kalinin Igor A. Suchkov Michail U. Bakunov Vyacheslav T. Krivichin Sergey A. Matveev Artur A. Isaev Roman V. Deev
author_facet	Igor L. Plaksa Nina D. Mzhavanadze Roman E. Kalinin Igor A. Suchkov Michail U. Bakunov Vyacheslav T. Krivichin Sergey A. Matveev Artur A. Isaev Roman V. Deev
author_sort	Igor L. Plaksa
title	Pilot study of the safety and efficacy of angiogenic therapy in diabetic foot syndrome
title_short	Pilot study of the safety and efficacy of angiogenic therapy in diabetic foot syndrome
title_full	Pilot study of the safety and efficacy of angiogenic therapy in diabetic foot syndrome
title_fullStr	Pilot study of the safety and efficacy of angiogenic therapy in diabetic foot syndrome
title_full_unstemmed	Pilot study of the safety and efficacy of angiogenic therapy in diabetic foot syndrome
title_sort	pilot study of the safety and efficacy of angiogenic therapy in diabetic foot syndrome
publisher	Endocrinology Research Centre
publishDate	2019
url	https://doaj.org/article/10ea3aa93c384104a861a4d47aaf033e
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Pilot study of the safety and efficacy of angiogenic therapy in diabetic foot syndrome

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