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Topically administered purified clinoptilolite‐tuff for the treatment of cutaneous wounds: A prospective, randomised phase I clinical trial

In an ageing society, chronic ulcers pose an increasingly relevant healthcare issue associated with significant morbidity and an increasing financial burden. Hence, there is an unmet medical need for novel, cost‐effective therapies that improve healing of chronic cutaneous wounds. This prospective,...

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Autores principales: Deinsberger, Julia, Marquart, Elias, Nizet, Stephane, Meisslitzer, Claudia, Tschegg, Cornelius, Uspenska, Kateryna, Gouya, Ghazaleh, Niederdöckl, Jan, Freissmuth, Michael, Wolzt, Michael, Weber, Benedikt
Formato: Online Artículo Texto
Lenguaje:English
Publicado: John Wiley & Sons, Inc. 2022
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9306511/
https://www.ncbi.nlm.nih.gov/pubmed/35043507
http://dx.doi.org/10.1111/wrr.12991
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author Deinsberger, Julia
Marquart, Elias
Nizet, Stephane
Meisslitzer, Claudia
Tschegg, Cornelius
Uspenska, Kateryna
Gouya, Ghazaleh
Niederdöckl, Jan
Freissmuth, Michael
Wolzt, Michael
Weber, Benedikt
author_facet Deinsberger, Julia
Marquart, Elias
Nizet, Stephane
Meisslitzer, Claudia
Tschegg, Cornelius
Uspenska, Kateryna
Gouya, Ghazaleh
Niederdöckl, Jan
Freissmuth, Michael
Wolzt, Michael
Weber, Benedikt
author_sort Deinsberger, Julia
collection PubMed
description In an ageing society, chronic ulcers pose an increasingly relevant healthcare issue associated with significant morbidity and an increasing financial burden. Hence, there is an unmet medical need for novel, cost‐effective therapies that improve healing of chronic cutaneous wounds. This prospective, randomised, open‐label, phase I trial investigated the safety and tolerability of topically administered purified clinoptilolite‐tuff (PCT), mainly consisting of the naturally occurring zeolite‐mineral clinoptilolite, in artificial wounds in healthy male volunteers compared to the standard of care (SoC). We found that topically administered PCT was safe for therapeutic application in acute wounds in healthy male volunteers. No significant differences in wound healing or wound conditions were observed compared to SoC‐treated wounds. However, we found a significantly higher proportion of CD68‐positive cells and a significantly lower proportion of α‐smooth muscle actin‐positive cells in PCT‐treated wounds. Scanning electron microscopy revealed PCT particles in the restored dermis in some cases. However, these did not impede wound healing or clinical symptoms. Hence, purified PCT could represent an attractive, cost‐effective wound treatment promoting the process of healing.
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spelling pubmed-93065112022-07-28 Topically administered purified clinoptilolite‐tuff for the treatment of cutaneous wounds: A prospective, randomised phase I clinical trial Deinsberger, Julia Marquart, Elias Nizet, Stephane Meisslitzer, Claudia Tschegg, Cornelius Uspenska, Kateryna Gouya, Ghazaleh Niederdöckl, Jan Freissmuth, Michael Wolzt, Michael Weber, Benedikt Wound Repair Regen Original Research‐Clinical Science In an ageing society, chronic ulcers pose an increasingly relevant healthcare issue associated with significant morbidity and an increasing financial burden. Hence, there is an unmet medical need for novel, cost‐effective therapies that improve healing of chronic cutaneous wounds. This prospective, randomised, open‐label, phase I trial investigated the safety and tolerability of topically administered purified clinoptilolite‐tuff (PCT), mainly consisting of the naturally occurring zeolite‐mineral clinoptilolite, in artificial wounds in healthy male volunteers compared to the standard of care (SoC). We found that topically administered PCT was safe for therapeutic application in acute wounds in healthy male volunteers. No significant differences in wound healing or wound conditions were observed compared to SoC‐treated wounds. However, we found a significantly higher proportion of CD68‐positive cells and a significantly lower proportion of α‐smooth muscle actin‐positive cells in PCT‐treated wounds. Scanning electron microscopy revealed PCT particles in the restored dermis in some cases. However, these did not impede wound healing or clinical symptoms. Hence, purified PCT could represent an attractive, cost‐effective wound treatment promoting the process of healing. John Wiley & Sons, Inc. 2022-01-27 2022 /pmc/articles/PMC9306511/ /pubmed/35043507 http://dx.doi.org/10.1111/wrr.12991 Text en © 2022 The Authors. Wound Repair and Regeneration published by Wiley Periodicals LLC on behalf of The Wound Healing Society. https://creativecommons.org/licenses/by-nc-nd/4.0/This is an open access article under the terms of the http://creativecommons.org/licenses/by-nc-nd/4.0/ (https://creativecommons.org/licenses/by-nc-nd/4.0/) License, which permits use and distribution in any medium, provided the original work is properly cited, the use is non‐commercial and no modifications or adaptations are made.
spellingShingle Original Research‐Clinical Science
Deinsberger, Julia
Marquart, Elias
Nizet, Stephane
Meisslitzer, Claudia
Tschegg, Cornelius
Uspenska, Kateryna
Gouya, Ghazaleh
Niederdöckl, Jan
Freissmuth, Michael
Wolzt, Michael
Weber, Benedikt
Topically administered purified clinoptilolite‐tuff for the treatment of cutaneous wounds: A prospective, randomised phase I clinical trial
title Topically administered purified clinoptilolite‐tuff for the treatment of cutaneous wounds: A prospective, randomised phase I clinical trial
title_full Topically administered purified clinoptilolite‐tuff for the treatment of cutaneous wounds: A prospective, randomised phase I clinical trial
title_fullStr Topically administered purified clinoptilolite‐tuff for the treatment of cutaneous wounds: A prospective, randomised phase I clinical trial
title_full_unstemmed Topically administered purified clinoptilolite‐tuff for the treatment of cutaneous wounds: A prospective, randomised phase I clinical trial
title_short Topically administered purified clinoptilolite‐tuff for the treatment of cutaneous wounds: A prospective, randomised phase I clinical trial
title_sort topically administered purified clinoptilolite‐tuff for the treatment of cutaneous wounds: a prospective, randomised phase i clinical trial
topic Original Research‐Clinical Science
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9306511/
https://www.ncbi.nlm.nih.gov/pubmed/35043507
http://dx.doi.org/10.1111/wrr.12991
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