Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 1:44 AM
Ignite Modification Date:
2025-12-25 @ 1:44 AM
NCT ID:
NCT06460194
Eligibility Criteria:
Inclusion Criteria:- Sequela following 2nd degree frostbite injury in the Norwegian Armed Forces
* Entering the Norwegian Armed Forces Health Registry (NAFHR) between 01.01.2010-31.12.2014
* Still suffering from sequelae related to frostbite injury in their fingers at least four years after their initial frostbite
* Have agreed on receiving a request to participate in the NAFHR quality assurance study.
Exclusion Criteria:- Patients who do not return the signed informed consent form
* Patients who cannot read Norwegian information or answer questions in the study
* Patients who are unable to comply the examination and treatment procedures
* Patients who are unable to travel to University Hospital North Norway in Tromsø for examination and treatment
* Patients who have undergone/is undergoing surgical treatment of hands/fingers
* Patients with known allergy/anaphylaxis in relation to the injection of BTX-A
* Patients who have used/are using drugs that interact with BTX-A injection (anticoagulants)
* Patients who are pregnant before start of the trial and/or during the trial
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
20 Years
Maximum Age:
65 Years
Study:
NCT06460194
Study Brief:
Protocol Section:
NCT06460194