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Blue Light Photobiomodulation Therapy on Neuroischemic Patients

NCT04831606 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 21

Last updated 2024-11-27

No results posted yet for this study

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.

Conditions

  • Diabetic Foot Ulcer

Interventions

PROCEDURE

debridement

Cleaning of the wound area

DEVICE

Offloading

Offloading performed with a standard brace to the calf (Optima Diab, from Molliter).

DEVICE

Advanced dressing

Protect the wound with Advanced dressing

DEVICE

Blue Light Photobiomodulation

2 minutes irradiation of blue light performed with EmoLED device

Sponsors & Collaborators

  • Ospedale San Donato

    collaborator OTHER

  • University of Pisa

    collaborator OTHER

  • Emoled

    lead INDUSTRY

Principal Investigators

  • Alberto Piaggesi, Doctor · Pisa University Hospital

  • Alessia Scatena, Doctor · San Donato Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-07-31
Primary Completion
2024-07-01
Completion
2024-07-01

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04831606 on ClinicalTrials.gov