Botulinum Toxin A in the treatment of frostbite sequelae–results from a blinded, early-phase, comparative trial
Introduction: Freezing Cold Injuries (FCI) have been associated with long-term sequelae including vasospasm. The aims of the pilot study are to explore the research methodology and investigate the tolerability and safety of treatment with Botulinum Toxin-A (BTX-A) in FCI Sequelae. Methodology: This...
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ftunivtroemsoe:oai:munin.uit.no:10037/30522 2023-09-26T15:17:13+02:00 Botulinum Toxin A in the treatment of frostbite sequelae–results from a blinded, early-phase, comparative trial Norheim, Arne Johan Borud, Einar Kristian Mercer, James de Weerd, Louis Weiss, Thomas Wilsgaard, Tom 2023-03-15 https://hdl.handle.net/10037/30522 https://doi.org/10.1080/22423982.2023.2189556 eng eng Taylor & Francis International Journal of Circumpolar Health Norheim, Borud, Mercer, de Weerd, Weiss, Wilsgaard. Botulinum Toxin A in the treatment of frostbite sequelae–results from a blinded, early-phase, comparative trial. International Journal of Circumpolar Health. 2023;82:1-10 FRIDAID 2138867 doi:10.1080/22423982.2023.2189556 1239-9736 2242-3982 https://hdl.handle.net/10037/30522 Attribution-NonCommercial 4.0 International (CC BY-NC 4.0) openAccess Copyright 2023 The Author(s) https://creativecommons.org/licenses/by-nc/4.0 Journal article Tidsskriftartikkel Peer reviewed publishedVersion 2023 ftunivtroemsoe https://doi.org/10.1080/22423982.2023.2189556 2023-08-30T23:07:24Z Introduction: Freezing Cold Injuries (FCI) have been associated with long-term sequelae including vasospasm. The aims of the pilot study are to explore the research methodology and investigate the tolerability and safety of treatment with Botulinum Toxin-A (BTX-A) in FCI Sequelae. Methodology: This pilot study tests the logistics, the treatment setting and the follow-up procedure in an early-phase, double-blinded, randomized, controlled trial study-design. The variables in the study were subjective symptoms, peripheral micro-vascularization/rewarming, somatosensory responsiveness, and generic measure of health status. Results: No major challenges or difficulties were noticed according to the protocol or the study methodology. The monitoring of tolerability and safety of treatment with BTX-A did not reveal any major unwanted and/or adverse reactions among the patients in the pilot study and no challenges occurred during data collection of endpoints. The study revealed an inaccuracy of the 2nd degree FCI diagnosis and uncover a need for relevant and sufficient clinical information for FCI classification. Conclusions: This pilot study showed the study methodology with minor adjustments is feasible in a future full-scale clinical trial. The recruitment process needs to be more refined to ensure that the eligible study participants are a homogenous group of FCI patients. Article in Journal/Newspaper Circumpolar Health International Journal of Circumpolar Health University of Tromsø: Munin Open Research Archive International Journal of Circumpolar Health 82 1 |
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University of Tromsø: Munin Open Research Archive |
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ftunivtroemsoe |
language |
English |
description |
Introduction: Freezing Cold Injuries (FCI) have been associated with long-term sequelae including vasospasm. The aims of the pilot study are to explore the research methodology and investigate the tolerability and safety of treatment with Botulinum Toxin-A (BTX-A) in FCI Sequelae. Methodology: This pilot study tests the logistics, the treatment setting and the follow-up procedure in an early-phase, double-blinded, randomized, controlled trial study-design. The variables in the study were subjective symptoms, peripheral micro-vascularization/rewarming, somatosensory responsiveness, and generic measure of health status. Results: No major challenges or difficulties were noticed according to the protocol or the study methodology. The monitoring of tolerability and safety of treatment with BTX-A did not reveal any major unwanted and/or adverse reactions among the patients in the pilot study and no challenges occurred during data collection of endpoints. The study revealed an inaccuracy of the 2nd degree FCI diagnosis and uncover a need for relevant and sufficient clinical information for FCI classification. Conclusions: This pilot study showed the study methodology with minor adjustments is feasible in a future full-scale clinical trial. The recruitment process needs to be more refined to ensure that the eligible study participants are a homogenous group of FCI patients. |
format |
Article in Journal/Newspaper |
author |
Norheim, Arne Johan Borud, Einar Kristian Mercer, James de Weerd, Louis Weiss, Thomas Wilsgaard, Tom |
spellingShingle |
Norheim, Arne Johan Borud, Einar Kristian Mercer, James de Weerd, Louis Weiss, Thomas Wilsgaard, Tom Botulinum Toxin A in the treatment of frostbite sequelae–results from a blinded, early-phase, comparative trial |
author_facet |
Norheim, Arne Johan Borud, Einar Kristian Mercer, James de Weerd, Louis Weiss, Thomas Wilsgaard, Tom |
author_sort |
Norheim, Arne Johan |
title |
Botulinum Toxin A in the treatment of frostbite sequelae–results from a blinded, early-phase, comparative trial |
title_short |
Botulinum Toxin A in the treatment of frostbite sequelae–results from a blinded, early-phase, comparative trial |
title_full |
Botulinum Toxin A in the treatment of frostbite sequelae–results from a blinded, early-phase, comparative trial |
title_fullStr |
Botulinum Toxin A in the treatment of frostbite sequelae–results from a blinded, early-phase, comparative trial |
title_full_unstemmed |
Botulinum Toxin A in the treatment of frostbite sequelae–results from a blinded, early-phase, comparative trial |
title_sort |
botulinum toxin a in the treatment of frostbite sequelae–results from a blinded, early-phase, comparative trial |
publisher |
Taylor & Francis |
publishDate |
2023 |
url |
https://hdl.handle.net/10037/30522 https://doi.org/10.1080/22423982.2023.2189556 |
genre |
Circumpolar Health International Journal of Circumpolar Health |
genre_facet |
Circumpolar Health International Journal of Circumpolar Health |
op_relation |
International Journal of Circumpolar Health Norheim, Borud, Mercer, de Weerd, Weiss, Wilsgaard. Botulinum Toxin A in the treatment of frostbite sequelae–results from a blinded, early-phase, comparative trial. International Journal of Circumpolar Health. 2023;82:1-10 FRIDAID 2138867 doi:10.1080/22423982.2023.2189556 1239-9736 2242-3982 https://hdl.handle.net/10037/30522 |
op_rights |
Attribution-NonCommercial 4.0 International (CC BY-NC 4.0) openAccess Copyright 2023 The Author(s) https://creativecommons.org/licenses/by-nc/4.0 |
op_doi |
https://doi.org/10.1080/22423982.2023.2189556 |
container_title |
International Journal of Circumpolar Health |
container_volume |
82 |
container_issue |
1 |
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1778138601828122624 |