Ignite Creation Date:
2024-05-06 @ 8:18 PM
Last Modification Date:
2024-10-26 @ 3:25 PM
Study NCT ID:
NCT06333171
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-03-27
First Post:
2024-03-20
Brief Title:
4-aminopyridine for Skin Wound Healing
Sponsor:
John Elfar
Organization:
University of Arizona
Study Overview
Official Title:
4-aminopyridine for Skin Wound Healing
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 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
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
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 investigators 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
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 investigators 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None