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 ElfarProduct
4-AminopyridineIndication
WoundIndication
Skin WoundIndication
Wound HealingIndication
Injuries