NCT07427732

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).

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 17, 2026

Completed
5 days until next milestone

Study Start

First participant enrolled

February 22, 2026

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 23, 2026

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 20, 2026

Completed
7 days until next milestone

Study Completion

Last participant's last visit for all outcomes

April 27, 2026

Completed
Last Updated

February 24, 2026

Status Verified

February 1, 2026

Enrollment Period

2 months

First QC Date

February 17, 2026

Last Update Submit

February 20, 2026

Conditions

Diabetic Foot Ulcer

Outcome Measures

Primary Outcomes (2)

  • 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.

    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.

    6 weeks

Study Arms (2)

Monochromatic Infrared Energy therapy group

EXPERIMENTAL

15 patients will receive Monochromatic Infrared Energy (MIRE) therapy in addition to standard wound care.

Device: Monochromatic Infrared Energy therapyOther: Standard wound care

Standard wound care group

ACTIVE COMPARATOR

15 patients will receive standard wound care only.

Other: Standard wound care

Interventions

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.

Monochromatic Infrared Energy therapy group
Standard wound careOTHER

Patients will receive standard wound care only, which will include wound debridement, infection control, and glucose management.

Monochromatic Infrared Energy therapy groupStandard wound care group

Eligibility Criteria

Age40 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fatma Mohamed Sayed

Cairo, Egypt

Location

MeSH Terms

Conditions

Diabetic Foot

Condition Hierarchy (Ancestors)

Diabetic AngiopathiesVascular DiseasesCardiovascular DiseasesFoot UlcerLeg UlcerSkin UlcerSkin DiseasesSkin and Connective Tissue DiseasesDiabetes ComplicationsDiabetes MellitusEndocrine System DiseasesDiabetic Neuropathies

Study Officials

  • Marwa Mahdy, PHD

    Cairo University

    STUDY DIRECTOR

  • Amal Abd El-Baky, Professor

    Cairo University

    STUDY CHAIR

Central Study Contacts

Fatma Sayed, Master

CONTACT

01147854238fatmamohamed10796@gmail.com

Mohamed youssed, Professor

CONTACT

01111770810mdrmohtaha@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

February 17, 2026

First Posted

February 23, 2026

Study Start

February 22, 2026

Primary Completion

April 20, 2026

Study Completion

April 27, 2026

Last Updated

February 24, 2026

Record last verified: 2026-02

Locations

EG(1)