RecruitingPhase 2NCT06333171

4-aminopyridine for Skin Wound Healing


Sponsor

John Elfar

Enrollment

150 participants

Start Date

Sep 1, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

Many patients suffer from chronic non-healing wounds as well as acute wounds. There is a need to develop treatments to accelerate and improve healing of chronic and acute wounds. More research is needed to evaluate the role of 4-aminopyridine (4-AP), a promising new agent with an excellent safety profile, on wound healing. The investigational treatment will be used to evaluate the role of (4-AP) on the treatment of wounds to accelerate wound healing in healthy adults. The purpose of this study is to evaluate the role of 4-AP on the treatment of wounds to accelerate healing. The investigational treatment will be used to test the hypothesis that 4-AP can speed wound healing.


Eligibility

Min Age: 18 YearsMax Age: 70 Years

Inclusion Criteria6

  • 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 Criteria15

  • 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

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Interventions

DRUG4-Aminopyridine

Active study drug

OTHERPlacebo

Placebo comparator


Locations(1)

University of Arizona

Tucson, Arizona, United States

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NCT06333171


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