Actively Recruiting
4-Aminopyridine to Treat Skin Burns
Led by John Elfar · Updated on 2026-03-05
200
Participants Needed
1
Research Sites
13 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Many patients suffer from traumatic burns, and current treatments mainly focus on infection prevention and fluid management without improving the skin's ability to regenerate. This research aims to evaluate the role of 4-aminopyridine (4-AP), a promising agent with a good safety profile, in accelerating burn wound healing in patients with second-degree burns. The study addresses the need for new regenerative treatments that can speed up recovery while allowing existing protocols to continue. Participants will be randomly assigned to receive either 4-aminopyridine capsules (10 mg every 12 hours) or a placebo capsule on the same schedule. This phase 2 study will compare these two groups over a 12-month period to assess the treatment's effect on the healing process. The study uses triple masking to ensure unbiased results. During the study, participants will be monitored for healing rate, skin graft requirements, scar formation, and scar sensitivity over 12 months. They will provide informed consent and attend scheduled follow-up visits where researchers will evaluate wound healing through sensory and motor assessments and calibrated wound photographs. Safety and adherence will be closely tracked to evaluate the treatment's impact and patient outcomes throughout the study period.
CONDITIONS
Brief Title
4-Aminopyridine to Treat Skin Burns
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Injured adults with second-degree burns
- Burns covering at least 6 cm² of skin
- Acute burns within 7 days of injury
- Cognitive ability to assess burn healing and report symptoms
- Adults aged 18 to 80 years
- Ability to provide written informed consent
- Able to attend all scheduled follow-up visits safely
You will not qualify if you...
- History of multiple sclerosis, stroke, or other neurological disorders
- Hypersensitivity to AMPYRA® or 4-aminopyridine
- Current use of aminopyridine medications or compounded 4-AP
- Suspected kidney problems based on questionnaire
- History of poor compliance with follow-up
- Outside the age range of 18 to 80 years
- Unable to provide informed consent
- Known seizure disorder
- Traumatic brain injury
- Unable to communicate
- Unwilling to complete study requirements
- Currently taking OCT2 inhibitors like Cimetidine
- Pregnant, breastfeeding, or incarcerated individuals
- Non-English speaking
- Unable or unwilling to take calibrated photographs of wounds
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Up to 12 months
Participants receive either 4-aminopyridine or placebo capsules every 12 hours to treat skin burns and accelerate healing.
Multiple visits scheduled throughout treatment period
Duration - Up to 12 months after treatment begins
Participants return for follow-up visits to assess healing rate, skin-graft rate, scar formation, and scar sensitivity.
Scheduled follow-up visits during the 12-month period
Trial Site Locations
Total: 1 location
1
University of Arizona
Tucson, Arizona, United States, 85724
Actively Recruiting
Research Team
C
Carly J Deal, MPH
V
Veronica Rangel, BS
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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