Diabetic Foot Ulcer
Conditions
Brief summary
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).
Detailed description
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.
Interventions
DEVICEMonochromatic Infrared Energy therapy
Patients will receive Monochromatic Infrared Energy (MIRE) therapy in addition to standard wound care. Intervention will be applied for 3 times a week for 6 consecutive weeks.
OTHERStandard wound care
Patients will receive standard wound care only, which will include wound debridement, infection control, and glucose management.
Sponsors
Cairo University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
40 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* 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.
Exclusion criteria
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Wound Progress Analysis | 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) | 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. |
Countries
Egypt
Contacts
CONTACTFatma Sayed, Master
CONTACTMohamed youssed, Professor
STUDY_DIRECTORMarwa Mahdy, PHD
Cairo University
STUDY_CHAIRAmal Abd El-Baky, Professor
Cairo University
Outcome results
None listed