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临床试验/NCT07645495
NCT07645495尚未招募不适用

Chronic Ulcer Healing With Frequency Rhythmic Electrical Modulated Stimulation (FREMS)Therapy and Phenytoin Application in Diabetic Patients.

Beni-Suef University1 个研究点 分布在 1 个国家目标入组 26 人开始时间: 2026年7月1日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
入组人数
26
试验地点
1

研究概览

简要总结

The goal of the study is to

  1. 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.
  2. 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.
  3. To compare the results of the 2 groups and determine the significance of the treatment.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
40 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • chronic ulcers more than 3 months.

排除标准

  • 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.

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Ibtihal Nassar

physiotherapist.

Beni-Suef University

研究点 (1)

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