4-aminopyridine for Skin Wound Healing

Recruiting now · Phase 2 · Has a placebo group

Conditions studied: Wounds, Wound of Skin, Wound Heal, Wounds and Injuries

In brief

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.

Key facts

Study ID

NCT06333171

Run by

John Elfar

People needed

150

Starts

2025-09-01

Expected to finish

2028-03-01

Last updated by the study team

2025-09-03

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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 it is running

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

Full record on ClinicalTrials.gov

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