Blue Light Photobiomodulation Therapy on Neuroischemic Patients
Key facts
- Who runs it
- Emoled
- Where
- Italy1 site in 1 countryChoose a country to see its sites
- Trial code
- Status
- Terminated
- People taking part
- 21 people enrolled
- Started
- 31 Jul 2021
- Ended
- 1 Jul 2024
- Type of study
- Interventional, 2 groupsOne group gets an existing treatment, for comparison.
- Treatments tested
- debridement
- Offloading
- Advanced dressing
- Blue Light Photobiomodulation
- Record updated
- 27 November 2024
- Why it stopped
- very low enrollment rate
Who can take part
- Age
- 18 years and older
- Sex
- Women and men
- Healthy volunteers
- Cannot take part
The registry criteria, word for word
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Who can take part
- Patients suffering from neuro-ischemic diabetic foot ulcer grade IC or IIC according to the University of Texas Wound Classification; If the patient has two or more lesions, which may fall within the inclusion criteria, the most serious lesion (index lesion) will be selected and followed for the entire duration of the study
- Patients who, following hospital discharge or after the first outpatient assessments, are followed by Home Care and are always monitored at the same referral center
- Patients with type I or II diabetes, with blood glucose ≤ 10%
- Patients willing to constantly wear the offload braces prescribed by the reference center
- Patients with ulcer localized on the finger, lateral, plantar, or dorsal part of the foot with an extension greater than 1 sqcm
- Patients with confirmed neuropathy with Monofilament (Semmes-Weinstein 5.07 / 10g)
- Patients with ABPI between 0.7 - 0.9, ankle PA> 70mmHg, TcPO2 between 36 - 50 mmHg
- Patients with lesions lasting between 1 and 24 months
- Patients who understand the purpose of the Clinical Study and provide their informed consent in writing
Who cannot take part
- Patients who have participated in a clinical study with a drug or medical device for less than a month
- Patients who underwent revascularization in the previous two months
- Patients who have presented an acute ischemic event within the previous 3 months
- Patient on high dose corticosteroid therapy (≥ 40 mg/day)
- Patients with pathologies or under treatment with drugs that induce photosensitization of the skin
- Patients with a history of self-harm who can voluntarily alter the course of healing
- Patients with psychiatric disorders
- Patients who are unable to understand the aims and objectives of the study
- Patients who are bedridden or unable to walk or Patients with neoplasms
- Patients with pressure ulcers
- Patients who have infectious signs according to IDSA criteria
- Patients with heel injuries
- Patients with nephropathy undergoing dialysis
- Patients with osteomyelitis
- Patients with Charcot's neuro-arthropathy:
- Women who are pregnant or breastfeeding
- Patients with a life expectancy of less than one year
This trial has no sites in United States.
It has sites in one country. Choose a country to see its sites.
About the trial
What the trial wants to find out
This is a pilot case/control clinical study on a group of outpatients with diabetic foot lesions aiming to verify the efficacy and safety of the Blue light photobiomodulation therapy with EmoLED medical device, in addition to standard therapy compared to the standard therapy alone, evaluating the percentage of healed lesions (which have reached complete and lasting re-epithelialization), the evaluation of the healing time and reduction of the ulcerated area during the time of observation, the perception of pain and the quality of life of the enrolled patients.
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The aim of this study is therefore to determine any differences in outcome between the two groups considered and, in particular, if the therapy of the group being treated is more effective than the standard therapy in terms of percentage of healed lesions, healing time, and reduction of the ulcerated area, pain perception, and quality of life, and is at least as safe in terms of occurrence of adverse events.
The 2 groups in the trial
- Control ArmExisting treatment, for comparison
Patients will receive a biweekly standard treatment at home according to the International Working Group on Diabetic Foot consisting of: Debridement of the lesion, unloading with a brace up to the calf, non-removable (except for contraindications), dressing of the wound with advanced dressings in use at the specialized center and in the home care network.
Treatment: debridement, Offloading, and Advanced dressing
- EmoLED ArmTreatment being tested
Patients on top of the standard treatment of the control arm will receive EmoLED blue light irradiation for two minutes at each biweekly medication.
Treatment: debridement, Offloading, Advanced dressing, and Blue Light Photobiomodulation
Data and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- A Single-center Prospective Randomized Controlled Study on the Efficacy of Blue Light in the Therapy of Neuro-ischemic Foot Lesions in Patients With Type I or II Diabetes in a Combined Hospital /Territory Treatment Regimen.
- Record updated
- 27 November 2024