Efficacy of a new local limb salvage treatment for limb-threatening diabetic foot wounds - a randomized controlled study

Mostafa Yakoot,1 Mahmoud Abdelatif,2 Sherine Helmy31Internal Medicine Department, Green Clinic and Research Center, Alexandria, Egypt; 2General Surgery Department, Alexandria Health Insurance Hospitals, Alexandria, Egypt; 3Research and Innovations, Pharco Corporate, Alexandria, EgyptCorrespondence:...

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Autores principales:	Yakoot M, Abdelatif M, Helmy S
Formato:	article
Lenguaje:	EN
Publicado:	Dove Medical Press 2019
Materias:	diabetic foot ulcers limb threatening local treatment royal jelly panthenol. Specialties of internal medicine RC581-951
Acceso en línea:	https://doaj.org/article/bbc9776ac0ff4d17962e698598db7ebf
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spelling	oai:doaj.org-article:bbc9776ac0ff4d17962e698598db7ebf2021-12-02T02:18:21ZEfficacy of a new local limb salvage treatment for limb-threatening diabetic foot wounds - a randomized controlled study1178-7007https://doaj.org/article/bbc9776ac0ff4d17962e698598db7ebf2019-09-01T00:00:00Zhttps://www.dovepress.com/efficacy-of-a-new-local-limb-salvage-treatment-for-limb-threatening-di-peer-reviewed-article-DMSOhttps://doaj.org/toc/1178-7007Mostafa Yakoot,1 Mahmoud Abdelatif,2 Sherine Helmy31Internal Medicine Department, Green Clinic and Research Center, Alexandria, Egypt; 2General Surgery Department, Alexandria Health Insurance Hospitals, Alexandria, Egypt; 3Research and Innovations, Pharco Corporate, Alexandria, EgyptCorrespondence: Mostafa YakootInternal Medicine Department, Green Clinic and Research Center, Alexandria 21121, EgyptTel +20 3 391 3725Email yakoot@yahoo.comBackground: Diabetic foot ulcer (DFU) is the main risk factor for nontraumatic lower-limb amputation. We hypothesized that by reversing the offending local tissue factors resulting from the low tissue supply of oxygen, inefficient fuel metabolism and acidosis, we can eradicate the infection and help to promote healing. This might be enhanced with the help of an innovated local preparation (PEDYPHAR®,) through its enriched alkaline ointment base and the regenerating growth factors of Royal Jelly (RJ) plus the antimicrobial, immune-modulatory nutritional and other biochemical properties of RJ and Panthenol. We conducted this study to test the safety and efficacy of PEDYPHAR ointment as an adjuvant in limb salvage management for patients with limb-threatening diabetic foot wounds.Methods: A prospective, randomized, controlled open-label study design with a mean follow-up period of 12 weeks. One hundred and nineteen eligible patients with diabetic foot wounds presenting to 3 outpatient clinics in Egypt were randomized to be treated with the local application of either PEDYPHAR or Panthenol ointment under dressing after conservative debridement of necrotic tissue and irrigation with warm normal saline.Results: At the end of the 12-week follow-up period, PEDYPHAR showed a higher rate of complete healing of limb-threatening wounds in the intent-to-treat population, 11 of 34 (32.4%) in PEDYPHAR-treated group versus 3/25 (12%) in the Panthenol-treated (control) group (p=0.034* [*indicates it is statistically significant]).Conclusion: We can conclude that PEDYPHAR could be an effective and safe conservative local adjuvant treatment for cases of diabetic foot infection.Registration number in ClinicalTrials.gov: NCT01531517.Keywords: diabetic foot ulcers, limb threatening, local treatment, Royal Jelly, PanthenolYakoot MAbdelatif MHelmy SDove Medical Pressarticlediabetic foot ulcerslimb threateninglocal treatmentroyal jellypanthenol.Specialties of internal medicineRC581-951ENDiabetes, Metabolic Syndrome and Obesity: Targets and Therapy, Vol Volume 12, Pp 1659-1665 (2019)
institution	DOAJ
collection	DOAJ
language	EN
topic	diabetic foot ulcers limb threatening local treatment royal jelly panthenol. Specialties of internal medicine RC581-951
spellingShingle	diabetic foot ulcers limb threatening local treatment royal jelly panthenol. Specialties of internal medicine RC581-951 Yakoot M Abdelatif M Helmy S Efficacy of a new local limb salvage treatment for limb-threatening diabetic foot wounds - a randomized controlled study
description	Mostafa Yakoot,1 Mahmoud Abdelatif,2 Sherine Helmy31Internal Medicine Department, Green Clinic and Research Center, Alexandria, Egypt; 2General Surgery Department, Alexandria Health Insurance Hospitals, Alexandria, Egypt; 3Research and Innovations, Pharco Corporate, Alexandria, EgyptCorrespondence: Mostafa YakootInternal Medicine Department, Green Clinic and Research Center, Alexandria 21121, EgyptTel +20 3 391 3725Email yakoot@yahoo.comBackground: Diabetic foot ulcer (DFU) is the main risk factor for nontraumatic lower-limb amputation. We hypothesized that by reversing the offending local tissue factors resulting from the low tissue supply of oxygen, inefficient fuel metabolism and acidosis, we can eradicate the infection and help to promote healing. This might be enhanced with the help of an innovated local preparation (PEDYPHAR®,) through its enriched alkaline ointment base and the regenerating growth factors of Royal Jelly (RJ) plus the antimicrobial, immune-modulatory nutritional and other biochemical properties of RJ and Panthenol. We conducted this study to test the safety and efficacy of PEDYPHAR ointment as an adjuvant in limb salvage management for patients with limb-threatening diabetic foot wounds.Methods: A prospective, randomized, controlled open-label study design with a mean follow-up period of 12 weeks. One hundred and nineteen eligible patients with diabetic foot wounds presenting to 3 outpatient clinics in Egypt were randomized to be treated with the local application of either PEDYPHAR or Panthenol ointment under dressing after conservative debridement of necrotic tissue and irrigation with warm normal saline.Results: At the end of the 12-week follow-up period, PEDYPHAR showed a higher rate of complete healing of limb-threatening wounds in the intent-to-treat population, 11 of 34 (32.4%) in PEDYPHAR-treated group versus 3/25 (12%) in the Panthenol-treated (control) group (p=0.034* [*indicates it is statistically significant]).Conclusion: We can conclude that PEDYPHAR could be an effective and safe conservative local adjuvant treatment for cases of diabetic foot infection.Registration number in ClinicalTrials.gov: NCT01531517.Keywords: diabetic foot ulcers, limb threatening, local treatment, Royal Jelly, Panthenol
format	article
author	Yakoot M Abdelatif M Helmy S
author_facet	Yakoot M Abdelatif M Helmy S
author_sort	Yakoot M
title	Efficacy of a new local limb salvage treatment for limb-threatening diabetic foot wounds - a randomized controlled study
title_short	Efficacy of a new local limb salvage treatment for limb-threatening diabetic foot wounds - a randomized controlled study
title_full	Efficacy of a new local limb salvage treatment for limb-threatening diabetic foot wounds - a randomized controlled study
title_fullStr	Efficacy of a new local limb salvage treatment for limb-threatening diabetic foot wounds - a randomized controlled study
title_full_unstemmed	Efficacy of a new local limb salvage treatment for limb-threatening diabetic foot wounds - a randomized controlled study
title_sort	efficacy of a new local limb salvage treatment for limb-threatening diabetic foot wounds - a randomized controlled study
publisher	Dove Medical Press
publishDate	2019
url	https://doaj.org/article/bbc9776ac0ff4d17962e698598db7ebf
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Efficacy of a new local limb salvage treatment for limb-threatening diabetic foot wounds - a randomized controlled study

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