Status:

RECRUITING

4-aminopyridine for Skin Wound Healing

Lead Sponsor:

John Elfar

Conditions:

Wounds

Wound of Skin

Eligibility:

All Genders

18-70 years

Phase:

PHASE2

Brief 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 need...

Detailed Description

Worldwide, hundreds of millions of patients suffer from chronic non-healing wounds. In addition, most people will experience acute wounding at some point in their life. There is a need to develop agen...

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

Key Trial Info

Start Date :

September 1 2025

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

March 1 2028

Estimated Enrollment :

150 Patients enrolled

Trial Details

Trial ID

NCT06333171

Start Date

September 1 2025

End Date

March 1 2028

Last Update

September 3 2025

Active Locations (1)

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1

University of Arizona

Tucson, Arizona, United States, 85724