Evidence map›Paper›PMID 36919578›Full record

Trial reportInternational journal of circumpolar health2023

Botulinum Toxin A in the treatment of frostbite sequelae - results from a blinded, early-phase, comparative trial.

Arne Johan Norheim, Einar Borud, James Brian Mercer, Louis de Weerd, Thomas Weiss, Tom Wilsgaard

Open access · goldAbstract readRandomized Controlled Trial
In one paragraph

Trial report in International journal of circumpolar health, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 4 papers.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed
0.4field-weighted citation impact, top 37% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

4 citing papers in PubMed, 2 citations in OpenAlex.

  1. Synthesis of Protocols for Frostbite Care From the FROST Study Sites.Journal of burn care & research : official publication of the American Burn Association · 2026
    Observational
  2. Article
  3. Article
  4. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

6 authors at 3 institutions in 2 countries.

Arne Johan NorheimNational Research Centre of Complementary and Alternative Medicine (NAFKAM), Department of Community Medicine, UiT The Arctic University of Norway, Tromsø, Norway.ORCID 0000-0001-6939-2119
Einar BorudDepartment of Community Medicine, UiT The Arctic University of Norway, Tromsø, Norway.
James Brian MercerMedical Imaging Group. Institute for Clinical Medicine, Faculty of Health Sciences, UiT The Arctic University of Norway, Tromsø, Norway.ORCID 0000-0001-7754-3677
Louis de WeerdDepartment of Plastic Surgery and Hand Surgery, University Hospital of North Norway, Tromsø, Norway.
Thomas WeissClinical Psychology, Jena University, Jena, Germany.
Tom WilsgaardDepartment of Community Medicine, UiT The Arctic University of Norway, Tromsø, Norway.ORCID 0000-0002-2709-9472
UiT The Arctic University of Norway · NOJena University Hospital · DEUniversity Hospital of North Norway · NO

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionFreezing 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.

resultsNo 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.

conclusionsThis 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.

Indexed as

Botulinum Toxins, Type AFrostbiteHumansPilot ProjectsResearch DesignRewarmingTreatment OutcomeBotulinum Toxins, Type Abotulinum toxinBTXfreezing cold injuryFrostbitemilitaryquantitative sensory testsequelaethermography

Identifiers

PMID36919578
PMCPMC10026811
OpenAlexW4324302778

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
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Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.