NCT06333171 · John Elfar
4-aminopyridine for Skin Wound Healing
What this study is about
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.
View original scientific description
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.
Interventions
DRUG
4-Aminopyridine
Active study drug
OTHER
Placebo
Placebo comparator
Primary outcome measures
Return of skin integrity and wound closure after skin punch biopsy
Time frame: 6 weeks
Axillary skin punch biopsies will be performed on healthy volunteers. Wound healing will be measured using visual assessment.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
- Tucson, Arizona
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Sep 3, 2025 · Source of record for eligibility and locations