4-Aminopyridine to help heal second-degree skin burns

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase 2 interventional trial gives adults with acute second-degree burns either 4-aminopyridine or a placebo and follows them through scheduled visits to measure healing and safety. Eligible burns must be at least 6 cm2 and treated within seven days of injury, with participants able to report sensory and motor changes. The investigational drug is given as an add-on to standard burn care so current infection control and fluid management continue. Primary outcomes focus on the speed and quality of wound closure and monitoring for any treatment-related adverse effects.

Why it matters

Who can join: the full rules

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

Where it's running

• University of Arizona
  Tucson, Arizona, United States Recruiting

Study contacts

• Principal investigator: John Elfar, MD — University of Arizona
• Study coordinator: Carly J Deal, MPH
• Email: carlyjdeal@arizona.edu
• Phone: 520-626-1588

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.