Clinical Trial Details
— Status: Not yet recruiting
Administrative data
| NCT number |
NCT06333171 |
| Other study ID # |
00003872 |
| Secondary ID |
|
| Status |
Not yet recruiting |
| Phase |
Phase 2
|
| First received |
|
| Last updated |
|
| Start date |
July 2024 |
| Est. completion date |
March 2028 |
Study information
| Verified date |
March 2024 |
| Source |
University of Arizona |
| Contact |
Andrea Horne |
| Phone |
520-626-6456 |
| Email |
ahh[@]arizona.edu |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical 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. 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.
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:
1. 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.
2. 4-AP treatment was associated with no adverse events in animals at the doses used
consistent with our previous applications.
3. 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.
