Effect of Monochromatic Infrared Energy on Healing of Diabetic Foot Ulcers
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Wound Progress Analysis
研究概览
简要总结
The purpose of this study is to evaluate the effectiveness of monochromatic infrared energy (MIRE) as an adjunctive therapy for the healing of diabetic foot ulcers (DFUs).
详细描述
Diabetic foot ulcers (DFUs) are a major complication of diabetes mellitus, affecting millions of individuals worldwide and leading to significant morbidity, mortality, and healthcare costs. Despite advancements in medical care, DFUs continue to be a substantial clinical challenge due to their chronic nature and high risk of infection, which often results in lower limb amputations. Conventional treatment methods, such as wound debridement, and infection control are often insufficient in promoting timely wound healing, especially in patients with underlying complications such as peripheral neuropathy and ischemia. The global rise in diabetes prevalence further exacerbates the burden of DFUs, highlighting the need for more effective and innovative therapeutic approaches that can accelerate healing and reduce the occurrence of severe complications.
Monochromatic infrared energy (MIRE) could offer a new avenue for improving the healing outcomes of diabetic foot ulcers, which remain a leading cause of non-traumatic amputations. If MIRE is proven to be effective, this therapy could reduce the duration of ulcer healing, decrease the risk of infection and amputation, and improve the overall quality of life for patients with DFUs. Ultimately, the study has the potential to contribute to the reduction of healthcare costs associated with diabetic foot ulcers by improving patient outcomes and reducing the need for more invasive interventions.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 40 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of Diabetes Mellitus: Participants must have a confirmed diagnosis of Type 1 or Type 2 diabetes.
- •Presence of a Diabetic Foot Ulcer (DFU): Participants must have a current diabetic foot ulcer, typically classified as Wagner grade 1 or 2 (superficial or deep ulcers without bone involvement).
- •Ulcer Duration: The diabetic ulcer must be chronic, generally defined as a wound that has not healed within 30 days.
- •Adequate Circulation: Participants must have sufficient blood flow to the affected limb as confirmed by non-invasive vascular tests (e.g., Ankle-Brachial Index or Doppler ultrasound).
- •Ability to Consent: Participants must be able to provide informed consent and agree to comply with study protocols, including regular clinic visits for treatment and assessments.
排除标准
- •Active Infection or Osteomyelitis: Presence of an active infection at the ulcer site or underlying bone infection (osteomyelitis).
- •Wagner Grade 3 or Higher: Participants with more severe ulcers, such as those extending to bone or involving gangrene, will be excluded.
- •Severe Peripheral Arterial Disease (PAD): Participants with severe ischemia, as indicated by an Ankle-Brachial Index (ABI) below a certain threshold (e.g., < 0.5), will be excluded.
- •Use of Other Phototherapy Modalities: Participants currently receiving other forms of phototherapy, including low-level laser therapy (LLLT), will not be eligible.
- •Recent Surgery on the Affected Limb: Participants who have undergone recent surgical procedures on the ulcerated limb within the last 30 days.
- •Pregnancy: Pregnant individuals will be excluded due to the potential unknown effects of MIRE on fetal development.
- •Non-compliance Risk: Participants who are deemed unable to comply with the study protocol or follow-up schedule, due to cognitive impairment, substance abuse, or other factors.
- •Other Severe Comorbidities: Patients with severe comorbid conditions such as terminal illness or uncontrolled cardiovascular disease that may interfere with wound healing or study participation.
研究组 & 干预措施
Monochromatic Infrared Energy therapy group
15 patients will receive Monochromatic Infrared Energy (MIRE) therapy in addition to standard wound care.
干预措施: Standard wound care (Other)
Standard wound care group
15 patients will receive standard wound care only.
干预措施: Standard wound care (Other)
Monochromatic Infrared Energy therapy group
15 patients will receive Monochromatic Infrared Energy (MIRE) therapy in addition to standard wound care.
干预措施: Monochromatic Infrared Energy therapy (Device)
结局指标
主要结局
Wound Progress Analysis
时间窗: 6 weeks
Digital cameras, particularly those with high resolution and macro capabilities, are widely used in medical photography to document and monitor the progress of wounds over time. By capturing images at regular intervals, healthcare professionals can visually track changes in a wound's size (surface area in centimeter square) which is critical indicator of healing or deterioration. The reduction of wound size indicates better healing and progression. A software, Jasc Paint Shop Pro or JPEGView, medical professionals can enhance and analyze these images further. These image editing tools allow for the adjustment of brightness, contrast, and sharpness, which can highlight subtle changes in the wound that may not be immediately visible. For instance, increasing the contrast in an image might reveal areas of inflammation or infection that could otherwise go unnoticed. The reduction of wound size indicates better healing and progression.
Diabetic Foot Ulcer Scale (DFS)
时间窗: 6 weeks
The Diabetic Foot Ulcer Scale (DFS) is a specialized tool designed to assess the impact of diabetic foot ulcers on a patient's quality of life. the DFS consists of 58 items grouped into 11 domains: leisure, physical health, daily activities, emotions, noncompliance, family, friends, positive attitude, treatment, satisfaction, and financial. The minimum possible score (1) represented the worst quality of life, and the maximum possible score (5) represented the best quality of life. All of the DFS scales were scored from 0 to 100, with higher scores indicating worse quality of life.
次要结局
未报告次要终点
研究者
Fatma Mohamed Sayed
Principal investigator
Cairo University