WoundsPhase 2NCT06333171
4-aminopyridine for Skin Wound Healing
A Phase 2 study testing 4-Aminopyridine in people with Wounds and Wound of Skin, run by John Elfar at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Wounds, Wound of Skin, Wound Heal
- What is being tested?
- 4-Aminopyridine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 150 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2025to Mar 2028
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 15Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Arizona
Tucson, Arizona, 85724
Andrea Horne, 520-626-6456, ahh@arizona.edu
About this study
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.
Read the 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 agents to treat chronic and acute wounds. This need has intensified with the aging of the population, the rising incidence of diabetes and obesity, and the increasing number of patients undergoing treatment with medications that adversely affect wound healing.
Through experiments performed on animals with 4-aminopyridine, (currently marketed by Acorda Healthcare, Inc. in slow-release form as AMPYRA®, and available in generic form proposed for use in this study), the investigators found striking effects on wounds in the standard rodent model used in the literature. In these experiments, animals with wounds held open with stents, healed faster with mass-adjusted human doses of 4-AP. All relevant markers of tissue regeneration were augmented with 4-AP treatment. These injuries are considered standard models, used for decades that correlate to those encountered in the human patients.
The investigators found that:
- 4-AP administration over just 21 days led to a large augmentation of wound healing at time points as early as three days post injury.
- 4-AP treatment was associated with no adverse events in animals at the doses used consistent with our previous applications.
- Numerous measures of wound healing at the cellular level showed quantifiable improvement with treatment at the tissue level.
4-AP is used in some of the most fragile of neurologically-ailing patients and is currently a mainline treatment in the setting of multiple sclerosis. Multiple sclerosis patients suffer a demyelinating disorder that causes the stripping of the myelin sheath from around neurons in the peripheral and central nervous system. The myelin covering allows for normal conduction of impulses and, without such covering, impulses are small, impaired, impeded, and ineffective. The recognition that crush injuries to nerves do not simply sever the axonal fibers but also demyelinate some population of nerve cells has led to the idea to study the treatment of peripheral nerve traumatic injuries in humans using 4-AP and this continues to be the subject of some of the investigator's other translational work
There is extant literature demonstrating the positive effects of electrical stimulation in wound healing. Electrical stimulation of wounds has been shown to be effective in accelerating wound repair for diabetic foot ulcers and other chronic skin ulcers. Direct electrical stimulation of the skin is labor intensive, while 4-AP is more easily administered as an oral therapy. Thus, the recognition that re-innervation may improve healing in the wound bed - and that 4-AP has a differential, clinically relevant effect on nerves and wounds naturally leads to this application.
- Conditions
- Wounds, Wound of Skin, Wound Heal, Wounds and Injuries
- Being tested
- 4-Aminopyridine, Placebo
- Keywords
- 4 aminopyridine, wound healing
- Medical subject headings
- Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
4-AminopyridineDrug
Also called 4AP, dalfampridine
Active study drug
PlaceboOther
Placebo comparator
| Study group | Role | What they receive |
|---|---|---|
| Group A: 4-aminopyridine | Active comparator | dalfampridine (generic) 10 mg capsule po every 12 hours Receives: Drug: 4-Aminopyridine |
| Group B: Placebo | Placebo comparator | Placebo-1 capsule po every 12 hours Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Return of skin integrity and wound closure after skin punch biopsy
Axillary skin punch biopsies will be performed on healthy volunteers. Wound healing will be measured using visual assessment.
Measured: 6 weeks
Secondary outcomes (1)
The effect of 4-AP on the hair number and growth at the skin punch biopsy site.
The axillary skin punch biopsies will evaluated for the number of hair follicles and hair growth.
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2024
- Study startSep 2025 (estimated)
- Primary completionSep 2027 (estimated)
- Study completionMar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for WoundsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is a double-blind, randomized, placebo-controlled trial design.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- John Elfar
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, John Elfar, University of Arizona
- Investigators
- John Elfar, MD, Principal investigator, University of Arizona
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06333171
- Sponsor's protocol ID
- 00003872
- Status last verified
- Sep 2025
- First submitted
- 20 Mar 2024
- Last updated
- 3 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: No IPD will be shared with other researchers.
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 4-aminopyridine for Skin Wound Healing
- ClinicalTrials.gov ID
- NCT06333171
- Acronym / sponsor ID
- 00003872
- Conditions
- Wounds, Wound of Skin, Wound Heal, Wounds and Injuries
- Keywords
- 4 aminopyridine, wound healing
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- John ElfarUniversity, hospital or other
- Study start
- Sep 2025 (estimated)
- Primary completion
- Sep 2027 (estimated)
- Study completion
- Mar 2028 (estimated)
- First posted
- 27 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 agents to treat chronic and acute wounds. This need has intensified with the aging of the population, the rising incidence of diabetes and obesity, and the increasing number of patients undergoing treatment with medications that adversely affect wound healing.
Through experiments performed on animals with 4-aminopyridine, (currently marketed by Acorda Healthcare, Inc. in slow-release form as AMPYRA®, and available in generic form proposed for use in this study), the investigators found striking effects on wounds in the standard rodent model used in the literature. In these experiments, animals with wounds held open with stents, healed faster with mass-adjusted human doses of 4-AP. All relevant markers of tissue regeneration were augmented with 4-AP treatment. These injuries are considered standard models, used for decades that correlate to those encountered in the human patients.
The investigators found that:
- 4-AP administration over just 21 days led to a large augmentation of wound healing at time points as early as three days post injury.
- 4-AP treatment was associated with no adverse events in animals at the doses used consistent with our previous applications.
- Numerous measures of wound healing at the cellular level showed quantifiable improvement with treatment at the tissue level.
4-AP is used in some of the most fragile of neurologically-ailing patients and is currently a mainline treatment in the setting of multiple sclerosis. Multiple sclerosis patients suffer a demyelinating disorder that causes the stripping of the myelin sheath from around neurons in the peripheral and central nervous system. The myelin covering allows for normal conduction of impulses and, without such covering, impulses are small, impaired, impeded, and ineffective. The recognition that crush injuries to nerves do not simply sever the axonal fibers but also demyelinate some population of nerve cells has led to the idea to study the treatment of peripheral nerve traumatic injuries in humans using 4-AP and this continues to be the subject of some of the investigator's other translational work
There is extant literature demonstrating the positive effects of electrical stimulation in wound healing. Electrical stimulation of wounds has been shown to be effective in accelerating wound repair for diabetic foot ulcers and other chronic skin ulcers. Direct electrical stimulation of the skin is labor intensive, while 4-AP is more easily administered as an oral therapy. Thus, the recognition that re-innervation may improve healing in the wound bed - and that 4-AP has a differential, clinically relevant effect on nerves and wounds naturally leads to this application.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- This is a double-blind, randomized, placebo-controlled trial design.
| Arm | Type | Receives |
|---|---|---|
| Group A: 4-aminopyridine | Active comparator | Drug: 4-Aminopyridinedalfampridine (generic) 10 mg capsule po every 12 hours |
| Group B: Placebo | Placebo comparator | Other: PlaceboPlacebo-1 capsule po every 12 hours |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (15 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 4-AminopyridineAlso: 4AP, dalfampridineActive study drug | Drug | Group A: 4-aminopyridine |
| PlaceboPlacebo comparator | Other | Group B: Placebo |
Primary outcome
Return of skin integrity and wound closure after skin punch biopsy
Time frame: 6 weeks
Axillary skin punch biopsies will be performed on healthy volunteers. Wound healing will be measured using visual assessment.
1 secondary outcome
The effect of 4-AP on the hair number and growth at the skin punch biopsy site.
Time frame: 6 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Sep 2025.
- Individual participant dataSharing planned: No. No IPD will be shared with other researchers.
Related trials for Wounds
Recruiting
PAW-Hydrogel for Chronic Wound Healing
Diabetic Foot Ulcer (DFU), Pressure Ulcer (PU)
Not yet recruiting
Safety Study of Microlyte DualGuard
Wound Closure, Wound Care
Enrolling by invitation
Personalized Ventilator Settings for Patients on ECMO
Acute Respiratory Distress Syndrome (ARDS), Extracorporeal Membrane Oxygenation
Recruiting
Effects of Cervicothoracic Mobilization in Patients With Supraspinatus Tendinitis
Rotator Cuff Tendonitis
Recruiting
MyHand-SCI: An Active Hand Orthosis for Spinal Cord Injury
Spinal Cord Injuries, Tetraplegia
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
John Elfar, MD principal investigator
University of Arizona
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing 4-Aminopyridine in people with Wounds and Wound of Skin, run by John Elfar at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 3 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Andrea Horne (520-626-6456, ahh@arizona.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Return of skin integrity and wound closure after skin punch biopsy (time frame: 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Sep 2025.