Effect of Monochromatic Infrared Energy on Healing of Diabetic Foot Ulcers

February 20, 2026 updated by: Fatma Mohamed Sayed, Cairo University
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).

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Egypt
      • Cairo, Egypt
        • Fatma Mohamed Sayed

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Monochromatic Infrared Energy therapy group
15 patients will receive Monochromatic Infrared Energy (MIRE) therapy in addition to standard wound care.
Device: Monochromatic 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.
Other: Standard wound care
Patients will receive standard wound care only, which will include wound debridement, infection control, and glucose management.
Active Comparator: Standard wound care group
15 patients will receive standard wound care only.
Other: Standard wound care
Patients will receive standard wound care only, which will include wound debridement, infection control, and glucose management.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Wound Progress Analysis
Time Frame: 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.
6 weeks
Diabetic Foot Ulcer Scale (DFS)
Time Frame: 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.
6 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cairo University

Investigators

  • Study Director: Marwa Mahdy, PHD, Cairo University
  • Study Chair: Amal Abd El-Baky, Professor, Cairo University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

February 22, 2026

Primary Completion (Estimated)

April 20, 2026

Study Completion (Estimated)

April 27, 2026

Study Registration Dates

First Submitted

February 17, 2026

First Submitted That Met QC Criteria

February 17, 2026

First Posted (Actual)

February 23, 2026

Study Record Updates

Last Update Posted (Actual)

February 24, 2026

Last Update Submitted That Met QC Criteria

February 20, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 012/005596

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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