Diabetic Foot UlcerNCT07427732
Effect of Monochromatic Infrared Energy on Healing of Diabetic Foot Ulcers
A study testing Monochromatic Infrared Energy therapy and Standard wound care in people with Diabetic Foot Ulcer, run by Cairo University at 1 site in Egypt.
Trial 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). Read more about this study
- Who is it for?
- Ages 40 to 70 years
- Conditions the study is for
- Diabetic Foot Ulcer
- What is being tested?
- Monochromatic Infrared Energy therapy and Standard wound care
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteEgypt
- Study dates
- 22 Feb 2026to 27 Apr 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
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).
Read the 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.
- Conditions
- Diabetic Foot Ulcer
- Being tested
- Monochromatic Infrared Energy therapy, Standard wound care
- Medical subject headings
- Diabetic Foot
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Monochromatic Infrared Energy therapyDevice
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.
Standard wound careOther
Patients will receive standard wound care only, which will include wound debridement, infection control, and glucose management.
| Study group | Role | What they receive |
|---|---|---|
| Monochromatic Infrared Energy therapy group | Experimental | 15 patients will receive Monochromatic Infrared Energy (MIRE) therapy in addition to standard wound care. Receives: Device: Monochromatic Infrared Energy therapy; Other: Standard wound care |
| Standard wound care group | Active comparator | 15 patients will receive standard wound care only. Receives: Other: Standard wound care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Wound Progress Analysis
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.
Measured: 6 weeks
Diabetic Foot Ulcer Scale (DFS)
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.
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2026
- Study start22 Feb 2026 (estimated)
- Primary completion20 Apr 2026 (estimated)
- Study completion27 Apr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic Foot UlcerStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fatma Mohamed Sayed, Cairo University
- Investigators
- Marwa Mahdy, PHD, Study director, Cairo UniversityAmal Abd El-Baky, Professor, Study chair, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07427732
- Sponsor's protocol ID
- 012/005596
- Status last verified
- Feb 2026
- First submitted
- 17 Feb 2026
- Last updated
- 24 Feb 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Monochromatic Infrared Energy on Healing of Diabetic Foot Ulcers
- ClinicalTrials.gov ID
- NCT07427732
- Acronym / sponsor ID
- 012/005596
- Conditions
- Diabetic Foot Ulcer
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 22 Feb 2026 (estimated)
- Primary completion
- 20 Apr 2026 (estimated)
- Study completion
- 27 Apr 2026 (estimated)
- First posted
- 23 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Monochromatic Infrared Energy therapy group | Experimental | Device: Monochromatic Infrared Energy therapy, Other: Standard wound care15 patients will receive Monochromatic Infrared Energy (MIRE) therapy in addition to standard wound care. |
| Standard wound care group | Active comparator | Other: Standard wound care15 patients will receive standard wound care only. |
Who may qualify
- Ages
- 40 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Monochromatic Infrared Energy therapyPatients 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. | Device | Monochromatic Infrared Energy therapy group |
| Standard wound carePatients will receive standard wound care only, which will include wound debridement, infection control, and glucose management. | Other | Monochromatic Infrared Energy therapy group, Standard wound care group |
Primary outcome
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.
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Feb 2026.
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Evaluation of Personalized Nutritional Intervention on Wound Healing of Cutaneous Ulcers in Diabetics
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Marwa Mahdy, PHD study director
Cairo University
Amal Abd El-Baky, Professor study chair
Cairo University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Monochromatic Infrared Energy therapy and Standard wound care in people with Diabetic Foot Ulcer, run by Cairo University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 24 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Fatma Sayed, Master (01147854238, fatmamohamed10796@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Wound Progress Analysis (time frame: 6 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Feb 2026.