Clinical trial

4-aminopyridine for Skin Wound Healing

Name
00003872
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.
Trial arms
Trial start
2024-07-01
Estimated PCD
2027-09-01
Trial end
2028-03-01
Status
Not yet recruiting
Phase
Early phase I
Treatment
4-Aminopyridine
Active study drug
Arms:
Group A: 4-aminopyridine
Other names:
4AP, dalfampridine
Placebo
Placebo comparator
Arms:
Group B: Placebo
Size
68
Primary endpoint
Return of skin integrity and wound closure after skin punch biopsy
6 weeks
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
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'This is a double-blind, randomized, placebo-controlled trial design.', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'DOUBLE', 'maskingDescription': 'Subjects in both aims will be assigned to Group A or Group B using a randomization scheme. Each study participant for each aim is randomly assigned to either treatment of placebo using permuted block randomization', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}}, 'enrollmentInfo': {'count': 68, 'type': 'ESTIMATED'}}
Updated at
2024-03-27

1 organization

1 product

4 indications

Organization
John Elfar
Indication
Wound
Indication
Skin Wound
Indication
Wound Healing
Indication
Injuries