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