Effect of Monochromatic Infrared Energy on Healing of Diabetic Foot Ulcers

Overview

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

• 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.

Primary outcome measures

• Wound Progress Analysis [Time frame: 6 weeks]
• Diabetic Foot Ulcer Scale (DFS) [Time frame: 6 weeks]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Single blind

Primary purpose

Treatment

Study locations

Egypt · 1 center

• Fatma Mohamed Sayed — Cairo

Identifiers

NCT: NCT07427732 · 012/005596

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗