RecruitingPhase 2NCT06596434

4-Aminopyridine to Treat Skin Burns

Sponsor

John Elfar

Enrollment

200 participants

Start Date

Jan 1, 2026

Study Type

INTERVENTIONAL

Conditions

Wounds and Injuries Burns Second Degree Burn

Summary

Many patients suffer from traumatic burns and current treatments do not increase the regenerative potential of either skin grafts or the remaining uninjured skin. There is a need to develop treatments to accelerate and improve healing of burn injuries. More research is needed to evaluate the role of 4-AP, a promising new agent with an excellent safety profile, on wound and burn healing. The investigational treatment will be used to test the hypothesis that 4-AP accelerates burn healing in traumatically burned patients.

Eligibility

Min Age: 18 Years

Inclusion Criteria7

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 Criteria15

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