4-Aminopyridine to Treat Skin Burns

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.

Study Overview

• Status: Recruiting
• Conditions: Wounds and Injuries; Burns; Second Degree Burn
• Intervention / Treatment: Other: Placebo; Drug: Drug: 4-Aminopyridine

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 bacteria allowed to infiltrate deeper tissues by the absence of a skin barrier. If bacteria can now get into these tissues, the problem is only made worse by the large amount of hydration that now can get out into the environment from the open wound. Desiccation sets in with deeper tissues losing fluids. This renders tissue significantly more susceptible to further infection, as dry tissues are less perfused and less capable of fighting infectious insults. Desiccation also robs burned patients of fluids vital to sustain cardiopulmonary function. Without skin, patients essentially lose fluids and cannot perfuse even the most vital organs with time.

Research in the field focuses on preventing complications and temporizing these two factors. No regenerative treatments are currently offered to accelerate wound healing, and few investigative treatments are ready for translation to human trials. Most of the pipelines for future treatment involve long development timelines and still focus chiefly on infection control instead of driving tissue to regenerate and heal faster. A significant gap is the need for a regenerative burn treatment that can be trialed while still allowing the use of current protocols. An adjuvant regenerative burn treatment is needed.

The purpose of this study is to evaluate the role of local 4-aminopyridine (4-AP) on the treatment of burn wounds to accelerate healing.

• Study Type: Interventional
• Enrollment (Estimated): 200
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Carly J Deal, MPH; Phone Number: 520-626-1588; Email: carlyjdeal@arizona.edu
• Study Contact Backup: Name: Veronica Rangel, BS; Phone Number: 5206264024; Email: vrangel@arizona.edu

Study Locations

• United States
  • Arizona
    • Tucson, Arizona, United States, 85724
      • Recruiting
      • University of Arizona
      • Contact: Carly J Deal; Phone Number: 520-626-1588; Email: carlyjdeal@arizona.edu
      • Contact: Veronica Rangel, BS; Phone Number: 5206164024; Email: vrangel@arizona.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Group A: 4-aminopyridine; Dalfampridine (generic) 10 mg capsule PO every 12 hours	Drug: Drug: 4-Aminopyridine; Active study drug; Other Names: 4-AP; Dalfampridine; 4AP
Placebo Comparator: Group B: Placebo; Placebo - 1 capsule PO every 12 hours	Other: Placebo; Placebo comparator

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Healing rate	Each subject will undergo detailed fiducial-marking augmented macroscopic imaging to determine baseline burn area measurement. These measurements will be repeated at each follow up study visit to assess healing rate.	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Skin-graft rate	Skin-graft rate (failure of healing)	12 months
Scar formation	Scar formation will be measured by the Patient and Observer Scar Assessment Scale (POSAS). Each item of the POSAS is rated on a 10-point score with total scores ranging from 6 to 60 with higher scores indicating increase severity of symptoms. These measurements will be repeated at each follow up study visit.	12 months
Scar sensitivity	Scar sensitivity will be measured by the Patient and Observer Scar Assessment Scale (POSAS). Each item of the POSAS is rated on a 10-point score with total scores ranging from 6 to 60 with higher scores indicating increase severity of symptoms. These measurements will be repeated at each follow up study visit to assess healing rate.	12 months

Collaborators and Investigators

• Sponsor: John Elfar
• Investigators: Principal Investigator: John Elfar, MD, University of Arizona

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2026
• Primary Completion (Estimated): June 1, 2028
• Study Completion (Estimated): September 1, 2028

Study Registration Dates

• First Submitted: August 29, 2024
• First Submitted That Met QC Criteria: September 13, 2024
• First Posted (Actual): September 19, 2024

Study Record Updates

• Last Update Posted (Actual): March 5, 2026
• Last Update Submitted That Met QC Criteria: March 4, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: Burns; Wounds; 4-aminopyridine; 4-AP; Second degree burn
• Additional Relevant MeSH Terms: Wounds and Injuries; Burns; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Amines; Aminopyridines; 4-Aminopyridine
• Other Study ID Numbers: 00005193

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No