4-aminopyridine for Skin Wound Healing

Launched by JOHN ELFAR · Mar 20, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a medication called 4-aminopyridine (4-AP) to see if it can help speed up the healing of skin wounds. Many patients struggle with wounds that take a long time to heal, and the goal of this study is to find out if 4-AP can help improve that healing process in healthy adults. The trial is currently not recruiting participants, but it aims to enroll adults aged 18 to 70 who are otherwise healthy and can provide informed consent.

To be eligible, participants should not have any serious skin conditions or neurological disorders, and they need to be able to attend follow-up appointments regularly. If someone joins the study, they will use 4-AP as part of their treatment plan and will be monitored to see how well their wounds heal over time. It’s important to note that certain individuals, such as those who are pregnant or have specific medical histories, will not be able to participate. Overall, this trial is hoping to find a new way to help wounds heal faster and improve the lives of those with chronic or acute wounds.

Gender

ALL

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