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Frostbite clinical trials

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NCT ID: NCT06460194 Withdrawn - Sensory Disorders Clinical Trials

Treatment of Frostbite Sequelae With Botulinum Toxin A

Start date: November 2022
Phase: Phase 2
Study type: Interventional

Background Digital vasospasm as part of frostbite sequelae is comparable to the vasospastic disorders found in Raynaud's phenomenon which has been successfully treated with Botulinum toxin type A injections in the palm of the hands. Aim of this pilot study To investigate the effect of Botulinum toxin type A for frostbite sequelae in the fingers. Hypothesis The null hypothesis which is that all study-subjects will have equal distribution of symptoms and measurements after treatment, regardless of injection with Botulinum toxin type A or placebo. Methodology A randomized, double-blind, placebo-controlled study design, The study population consists of four patients with frostbite sequelae. The patients are randomized to either treatment with Botulinum toxin type A or placebo Two patients in the primary treatment group will receive Botulinum toxin type A at their first injection at inclusion, while the two patients in the secondary treatment group will receive normal saline (placebo) as their first injection at inclusion. At 6 weeks follow up, the primary treatment group will receive their second injection of Botulinum toxin type A and the secondary treatment group now will receive their second injection, but this will be their first injection of Botulinum toxin type A. By using the described study-design, all participating soldiers will get treatment. However, the secondary treatment group will have a delayed onset of treatment with Botulinum toxin type A and serves as a control for the primary treatment group during the initial 6 weeks observation. Botulinum toxin A and placed will be injected near the neurovascular bundle at the A1 pulley in the palm of the hand using a total dosage 100 U per hand (concentration 50 U per ml), 8-12 U/ injection site. The effect of Botulinum toxin type A on subjective symptoms will be measured by Patients Subjective Symptom Score (PSSS) The effect of Botulinum toxin type A on peripheral microcirculation will be evaluated with dynamic infrared thermography (DIRT) of the dorsal side of the hands. Quantitative sensory testing will be used to evaluate the effect of Botulinum toxin type A on peripheral nerve function. Both DIRT and QST will be performed prior to the treatment with Botulinum toxin type A and placebo at the start of the pilot study, at 6 weeks as well as 6 weeks after the last injections. Statistical methods and data analysis will be performed according to the EMA guidelines for biostatistics. Statistical analysis will be performed according to the null hypothesis.

NCT ID: NCT06266494 Recruiting - Frostbite Clinical Trials

Prevention and Treatment of Frostbite Infection With Antimicrobial Pharmacokinetic Analysis

Frostbite
Start date: March 1, 2024
Phase: Phase 4
Study type: Interventional

This study will compare the effectiveness of two different treatments for preventing infection from frostbite injuries. These two treatments are A) aloe vera and B) long-acting silver wound dressings. The investigators will also study the safety and effectiveness of Dalbavancin, an FDA approved antibiotic used for treating people who develop frostbite wound infections, as well as evaluate how frostbite damage to individuals' bodies may affect how fast their kidney clear drugs from their systems.

NCT ID: NCT05777590 Recruiting - Frostbite Clinical Trials

Comparison of ICG Microangiography and Conventional Angiography in Severe Frostbite

Start date: February 3, 2023
Phase:
Study type: Observational

Severe frostbite injury is a significant cause of morbidity in northern climates. Minnesota has some of the highest numbers of severe frostbite injuries in North America. As a result, Regions Hospital has the best opportunity to study this disease process and improve outcomes for frostbite patients. The diagnostic methods for severe frostbite injury vary from institution to institution and there is no standard practice. Commonly utilized methods include conventional angiography, Technetium 99 triple phase bone scans, SPECT studies, Indocyanine Green microangiography, and doppler studies. The proposed pilot study aims to directly compare conventional angiography imaging to ICG microangiography in adult patients with severe frostbite. Severe frostbite is defined as 4th degree: frostbite resulting in vascular occlusion and tissue ischemia. Both imaging modalities have been used for the diagnosis and monitoring of severe frostbite injury but there has never been a study directly comparing these two imaging modalities.

NCT ID: NCT05280301 Recruiting - Frostbite Clinical Trials

Multicenter Sous Vide Frostbite

Start date: December 1, 2022
Phase: N/A
Study type: Interventional

The purpose of this study is to determine the efficacy of using sous vide devices for heating and maintaining the circulating warm water bath used in the rewarming of acute frostbite.

NCT ID: NCT04633174 Completed - Frostbite Clinical Trials

Sous Vide Rewarming for Frostbitten Extremities

Start date: January 14, 2021
Phase: N/A
Study type: Interventional

The purpose of this study is to determine the efficacy of using sous vide devices for heating and maintaining the circulating warm water bath used in the rewarming of acute frostbite.

NCT ID: NCT03405467 Completed - Clinical trials for Cardiopulmonary Arrest With Successful Resuscitation

10-years Nationwide Alpine Accidents in Austria

Start date: January 21, 2015
Phase: N/A
Study type: Observational

This observational study intends to analyze the characteristic of specific accidents happened in Austrian's mountainous regions. The mechanisms of accidents which are evaluated are lightning accidents, cardiopulmonary resuscitation with or without automated external defibrillator, frostbite injuries, accidents with flying vehicle (e.g. paraglider, hang-glider…).