NCT06333171 4-aminopyridine for Skin Wound Healing
| NCT ID | NCT06333171 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | John Elfar |
| Condition | Wounds |
| Study Type | INTERVENTIONAL |
| Enrollment | 150 participants |
| Start Date | 2025-09 |
| Primary Completion | 2027-09 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 150 participants in total. It began in 2025-09 with a primary completion date of 2027-09.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 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 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
Contact & Investigator
John Elfar, MD
PRINCIPAL INVESTIGATOR
University of Arizona
Frequently Asked Questions
Who can join the NCT06333171 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 70 Years, studying Wounds. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06333171 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT06333171 currently recruiting?
Yes, NCT06333171 is actively recruiting participants. Contact the research team at ahh@arizona.edu for enrollment information.
Where is the NCT06333171 trial being conducted?
This trial is being conducted at Tucson, United States.
Who is sponsoring the NCT06333171 clinical trial?
NCT06333171 is sponsored by John Elfar. The principal investigator is John Elfar, MD at University of Arizona. The trial plans to enroll 150 participants.