4-aminopyridine for faster skin wound healing

4-aminopyridine for Skin Wound Healing

This trial will see if 4-aminopyridine helps small skin wounds heal faster in healthy adults aged 18–70.

Quick facts

• Phase: PHASE2
• Study type: Interventional
• Enrollment: 150 (estimated)
• Ages: 18 Years to 70 Years
• Sex: All
• Sponsor: University of Arizona (other)
• Locations: 1 site (Tucson, Arizona)
• Trial ID: NCT06333171 on ClinicalTrials.gov

What this trial studies

This Phase 2 interventional study compares 4-aminopyridine (4-AP) to a placebo in otherwise healthy adult volunteers with small skin wounds that are expected to heal by secondary intention. Participants will receive either 4-AP or placebo and return for scheduled follow-up visits to monitor wound closure and collect clinical and cellular measures of tissue repair. The rationale is based on animal data showing accelerated healing and increased regenerative markers with 4-AP, and the study aims to translate those findings into humans. Safety, tolerability, and objective wound-healing endpoints will be tracked over the treatment period.

Who should consider this trial

Good fit: Ideal candidates are otherwise healthy adults aged 18–70 with small wounds of the axilla or upper inner arm expected to heal without surgical closure, who can give informed consent and attend follow-up visits.

Not a fit: People with prior neurological disorders (like MS or stroke), a history of seizures, known hypersensitivity to 4-aminopyridine, current use of aminopyridine drugs, suspected renal impairment, or complex chronic wounds are unlikely to benefit or be eligible.

Why it matters

Potential benefit: If successful, 4-aminopyridine could speed healing of uncomplicated skin wounds, potentially reducing healing time and related complications.

How similar studies have performed: Animal studies demonstrated striking improvements in wound closure and regenerative markers with 4-AP, but human data for wound healing are limited and this represents an early-phase human test.

Eligibility criteria

Inclusion Criteria:

* Otherwise healthy adult patients without skin conditions effecting the skin of the axilla or upper inner arm.
* Cognitive ability to evaluate wound healing, report sensory and motor deficit during examination.
* Eligible for standard of care plan for wound closure by secondary intention (normal healing without intervention).
* Adults subject aged 18-70
* 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 this trial is running

Tucson, Arizona

• University of Arizona — Tucson, Arizona, United States (RECRUITING)

Study contacts

• Principal investigator: John Elfar, MD — University of Arizona
• Study coordinator: Andrea Horne

Conditions: Wounds, Wound of Skin, Wound Heal, Wounds and Injuries, 4 aminopyridine, wound healing