Status:
NOT_YET_RECRUITING
4-Aminopyridine to Treat Skin Burns
Lead Sponsor:
John Elfar
Conditions:
Burns
Second Degree Burn
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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...
Detailed Description
Burn treatment has not appreciably changed in decades. Most treatments focus on infection prevention and control, as well as fluid management. This is because burns are universally infected with bacte...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2028
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT06596434
Start Date
September 1 2025
End Date
September 1 2028
Last Update
September 3 2025
Active Locations (1)
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1
University of Arizona
Tucson, Arizona, United States, 85724