Status:
TERMINATED
Blue Light Photobiomodulation Therapy on Neuroischemic Patients
Lead Sponsor:
Emoled
Collaborating Sponsors:
Ospedale San Donato
University of Pisa
Conditions:
Diabetic Foot Ulcer
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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 medic...
Detailed Description
This study will be conducted according to the standards of Good Clinical Practice and in compliance with the principles set out in the Declaration of Helsinki, with the UNI\_ISO\_14155\_2011 standard,...
Eligibility Criteria
Inclusion
- 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
- 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 according to IDSA criteria;
- Patients who underwent revascularization in the previous two months;
- Patients who have presented an acute ischemic event within the previous 3 months;
- Patients with heel injuries;
- Patients with nephropathy undergoing dialysis;
- Patients with osteomyelitis;
- Patients with Charcot's neuro-arthropathy:
- Patient on high dose corticosteroid therapy (≥ 40 mg/day);
- Patients with a history of self-harm who can voluntarily alter the course of healing;
- Patients with psychiatric disorders;
- Women who are pregnant or breastfeeding;
- Patients with pathologies or under treatment with drugs that induce photosensitization of the skin;
- Patients with a life expectancy of less than one year.
Key Trial Info
Start Date :
July 31 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2024
Estimated Enrollment :
21 Patients enrolled
Trial Details
Trial ID
NCT04831606
Start Date
July 31 2021
End Date
July 1 2024
Last Update
November 27 2024
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
San Donato Hospital
Arezzo, Italy, 52100