4-Aminopyridine to Treat Skin Burns

Launched by JOHN ELFAR · Sep 13, 2024

Keywords

ClinConnect Summary

This clinical trial is looking at a new treatment called 4-Aminopyridine (4-AP) to see if it can help heal traumatic burns, specifically second-degree burns. Many patients with burns struggle with current treatments that do not effectively promote healing, so researchers want to find out if 4-AP can speed up the healing process. The trial is open to adults aged 18 to 80 who have suffered second-degree burns that are no more than 7 days old and cover an area of at least 6 square centimeters. Participants must be able to understand and report on their healing process, and they need to agree to follow-up visits.

If you decide to participate, you will receive the investigational treatment and be monitored to see how well your burns heal. It's important to note that some people may not be eligible for the trial, such as those with certain neurological disorders, those who have had seizures, or those who cannot communicate or take part in the study's requirements. The trial is not yet recruiting participants, but it represents a hopeful step toward better treatments for burn injuries.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Injured (burned) adults with a maximum severity of second-degree burns.
• • Burns involving at least 6cm2 of skin area
• • Acute burns within 7 days of injury
• • Cognitive ability to evaluate burn healing, report sensory and motor deficit during examination.
• • Adults aged 18-80
• • Ability to give written informed consent.
• • Capable of safely coming in for follow up visits on all scheduled appointments.
• Exclusion Criteria:
• • History of multiple sclerosis, stroke or any other diagnosed neurological disorder
• • History of hypersensitivity to AMPYRA® or 4-aminopyridine
• • Current use of aminopyridine medications, including other compounded 4-AP
• • Suspected renal impairment based on the Choyke questionnaire.
• • History of difficult compliance with timely follow up
• • Patients outside the age range
• • Unable to provide informed consent.
• • Patients with a known history of a seizure disorder (4-AP overdose can, in selected cases, result in limited seizure activity).
• • Patients with a concomitant traumatic brain injury.
• • Patients unable to communicate.
• • Patients unwilling to complete the study requirements.
• • Patients currently taking organic cat-ion transporter 2 (OCT2) inhibitors, e.g. Cimetidine.
• • Pregnancy, breastfeeding or incarcerated individuals.
• • Non-English speaking
• • Patients unable or unwilling to take calibrated (with gauge) photographs of their wounds