Effect of Transdermal Insulin Therapy by Ultrasonographic in Wound Healing of Chronic Diabetic Patients
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 40
- 主要终点
- DMIST scale which is a valid and reliable scale for measuring depth, maceration, inflammation/infection, size, tissue type of the wound bed, type of wound edge, and tunneling/undermining.
研究概览
简要总结
The main aim of the study is to determine the effect of transdermal application of insulin therapy by phonophoresis in wound healing in diabetic patients the main question of the study: is insulin phonophoresis is effective in accelerating healing in patients with diabetes mellites? 40 patients will be randomly assigned to two groups group A will receive insulin phonophoresis plus hyper polarized laser therapy and standard wound cleaning and dressing three times weekly over four weeks.
Group B will receive hyper polarized laser therapy and standard wound cleaning and dressing three times weekly over four weeks.
详细描述
DIMST scale ( as an acronym from the initial domains of depth, maceration, inflammation/infection, size, tissue type of the wound bed, type of wound edge, and tunneling/undermining) will be used for assessment.
MANOVA will be used for statistical analysis between group comparison
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 40 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients will be included if they are free from any pathological condition like limb infection, local or proximate malignancy, and anti-coagulated patients.
排除标准
- •patients will be excluded if they have any pathological condition like limb infection, local or proximate malignancy, and anti-coagulated patients.
研究组 & 干预措施
Group A
subjects will receive Phonophoresis Insulin Therapy, hyperpolarized light therapy and Standard wound cleaning and dressing.
干预措施: Hyperpolarized light therapy and Standard wound cleaning and dressing. (Other)
Group B
subjects will receive hyperpolarized light therapy and Standard wound cleaning and dressing
干预措施: Hyperpolarized light therapy and Standard wound cleaning and dressing. (Other)
Group A
subjects will receive Phonophoresis Insulin Therapy, hyperpolarized light therapy and Standard wound cleaning and dressing.
干预措施: Insulin therapy phonophoresis (Other)
结局指标
主要结局
DMIST scale which is a valid and reliable scale for measuring depth, maceration, inflammation/infection, size, tissue type of the wound bed, type of wound edge, and tunneling/undermining.
时间窗: before first session and at the end of the treatment program (four weeks)
Zero will be the minimum score and 98 was the maximum, with a greater number denoting a more severe injury and a zero signaling full recovery
次要结局
未报告次要终点
研究者
Radwa Fayek Hammam
Lecturer at Basic Science Department, Faculty of Physical Therapy Modern University for Technology and Information
MTI University