Frequency Rhythmic Electrical Modulated Stimulation Therapy in Chronic Ulcers. (FREMS)
Chronic Ulcer Healing With Frequency Rhythmic Electrical Modulated Stimulation (FREMS)Therapy and Phenytoin Application in Diabetic Patients.
The goal of the study is to
- To measure wound size of chronic ulcers after using FREMS therapy and phenytoin application in the interventional group monthly till the end of the third month compared to baseline.
- To measure wound size of chronic ulcers after using standard of care in control group monthly till the end of the third month compared to baseline.
- To compare the results of the 2 groups and determine the significance of the treatment.
研究概览
详细说明
Wound ulcers including diabetic foot ulcers impose a substantial and escalating economic burden on healthcare systems worldwide. In the United States alone, chronic wounds affect over 10 million people and account for annual healthcare costs ranging from $28.1 to $96.8 billion. Major challenges persist, including antibiotic resistance, high recurrence rates, delayed healing in patients with comorbidities, and limited evidence for many advanced therapies. Additionally, cost, access to specialized care, and the need for individualized, multidisciplinary management remain significant barriers to optimal outcomes. Using two effective modalities in cases that are resistant to all known treatments, whether they are conservative or adjuvant, is a promising technique to end the entrapment of a wound in a certain stage and avoid complications like further amputation. enrolled patients will be randomly assigned to one of either groups Group A: Intervention group that will receive 3 sessions /week of FERM with phenytoin application with spraying phenytoin topical 40 mg spray after each session according to ulcer size to cover the ulcer.
Group B: Control group that will receive standard of care and will be assessed at baseline and every month till they completed 3 months of treatment.
研究类型
注册 (估计的)
阶段
- 不适用
联系人和位置
学习联系方式
- 姓名：Ibtihal Nassar, Msc.
- 电话号码：+201151678506
- 邮箱：ibtihalnassar@gothi.gov.eg
学习地点
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-
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Giza、埃及
- National diabetes institute
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接触：
- Ibtihal Nassar, Msc.
- 电话号码：+201151678506
- 邮箱：scholaribtihal@gmail.com
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接触：
- seham abdelmoghny, phd
- 电话号码：+201006920495
- 邮箱：ibtihalnassar@gothi.gov.eg
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首席研究员：
- Ibtihal Nassar, msc
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参与标准
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
描述
Inclusion Criteria:
- chronic ulcers more than 3 months.
Exclusion Criteria:
- incapable of being in the clinic of diabetic ulcer during treatment period 3 days/ week for 3 months.
- severe ischemia that is indicated for a surgery.
- infection or osteomyelitis.
学习计划
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的：chronic ulcers patients
FREMS therapy 3 sessions/week for 40 minutes with phenytoin spray 40mg.
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frequency rhythmic electrical stimulation which is an electrical device specialized in diabetes complications like ulcers and neuropathies, with proven efficacy in neuropathies, and promising results in ulcers.
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无干预：ulcers patients
control group: SOC(debridement and basic wound care)
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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healing rate
大体时间：measuring once a month for 3 months.
|
wound size
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measuring once a month for 3 months.
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合作者和调查者
出版物和有用的链接
研究记录日期
研究主要日期
学习开始 (估计的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
其他研究编号
- IDE00360
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
药物和器械信息、研究文件
研究美国 FDA 监管的药品
研究美国 FDA 监管的设备产品
在美国制造并从美国出口的产品
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