Blue Light Photobiomodulation Therapy on Neuroischemic Patients (NCT04831606) | Clinical Trial Compass
TerminatedNot Applicable
Blue Light Photobiomodulation Therapy on Neuroischemic Patients
Stopped: very low enrollment rate
Italy21 participantsStarted 2021-07-31
Plain-language summary
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.
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.
Who can participate
Age range18 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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.
Exclusion Criteria:
* Patients who have participated in a clinical study with a drug or medical device for less than a month;
* 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 accor…
What they're measuring
1
Percentage of healed lesions on the total lesions treated for each arm
Timeframe: 24 weeks (20 weeks treatment plus 4 weeks post treatment observation)