Effect of Monochromatic Infrared Energy on Healing of Diabetic Foot Ulcers

ConditionDiabetic Foot Ulcer

Trial statusNot yet recruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age40-70

SponsorCairo University

About this trial

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).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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).

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

Monochromatic Infrared Energy therapy
Device
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 care
Other intervention
Patients will receive standard wound care only, which will include wound debridement, infection control, and glucose management.

Treatment groups

40 Participants

are divided into 2 treatment groups

Group A: Monochromatic Infrared Energy therapy groupExperimental treatment 2 interventions

Group B: Standard wound care groupActive comparator 1 intervention

Trial outcomes

Primary outcomes

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.

Time frame

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.

Time frame

6 weeks

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Cairo University

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: