4-Aminopyridine to Treat Skin Burns
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Healing rate
研究概览
简要总结
Many patients suffer from traumatic burns and current treatments do not increase the regenerative potential of either skin grafts or the remaining uninjured skin. There is a need to develop treatments to accelerate and improve healing of burn injuries. More research is needed to evaluate the role of 4-AP, a promising new agent with an excellent safety profile, on wound and burn healing. The investigational treatment will be used to test the hypothesis that 4-AP accelerates burn healing in traumatically burned patients.
详细描述
Burn treatment has not appreciably changed in decades. Most treatments focus on infection prevention and control, as well as fluid management. This is because burns are universally infected with bacteria allowed to infiltrate deeper tissues by the absence of a skin barrier. If bacteria can now get into these tissues, the problem is only made worse by the large amount of hydration that now can get out into the environment from the open wound. Desiccation sets in with deeper tissues losing fluids. This renders tissue significantly more susceptible to further infection, as dry tissues are less perfused and less capable of fighting infectious insults. Desiccation also robs burned patients of fluids vital to sustain cardiopulmonary function. Without skin, patients essentially lose fluids and cannot perfuse even the most vital organs with time.
Research in the field focuses on preventing complications and temporizing these two factors. No regenerative treatments are currently offered to accelerate wound healing, and few investigative treatments are ready for translation to human trials. Most of the pipelines for future treatment involve long development timelines and still focus chiefly on infection control instead of driving tissue to regenerate and heal faster. A significant gap is the need for a regenerative burn treatment that can be trialed while still allowing the use of current protocols. An adjuvant regenerative burn treatment is needed.
The purpose of this study is to evaluate the role of local 4-aminopyridine (4-AP) on the treatment of burn wounds to accelerate healing.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
盲法说明
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 or placebo using permuted block randomization.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Injured (burned) adults with a maximum severity of second-degree burns.
- •Burns involving at least 6cm2 of skin area
- •Acute burns within 7 days of injury
- •Cognitive ability to evaluate burn healing, report sensory and motor deficit during examination.
- •Adults aged 18-80
- •Ability to give written informed consent.
- •Capable of safely coming in for follow up visits on all scheduled appointments.
排除标准
- •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
研究组 & 干预措施
Group B: Placebo
Placebo - 1 capsule PO every 12 hours
干预措施: Placebo (Other)
结局指标
主要结局
Healing rate
时间窗: 12 months
Each subject will undergo detailed fiducial-marking augmented macroscopic imaging to determine baseline burn area measurement. These measurements will be repeated at each follow up study visit to assess healing rate.
次要结局
- Skin-graft rate(12 months)
- Scar formation(12 months)
- Scar sensitivity(12 months)
研究者
John Elfar
Tenured Professor, Chairman, Department of Orthopaedic Surgery
University of Arizona