Status:
COMPLETED
Blu Light for Ulcers Reduction
Lead Sponsor:
Emoled
Collaborating Sponsors:
Akros Bioscience
Phidea Group
Conditions:
Leg Ulcers Venous
Dehiscence, Surgical Wound
Eligibility:
All Genders
18-99 years
Phase:
NA
Brief Summary
Multi-center study on the effectiveness of treatment with a blue light medical device (EmoLED) in the reduction of ulcer surface in 10 weeks. The aim of BLUR clinical trial is to verify if the propos...
Detailed Description
A total of 90 subjects will be recruited at the facilities involved in the clinical study. All patients, both hospitalised and outpatient, will be considered for inclusion in this study. The patients...
Eligibility Criteria
Inclusion
- Subjects suffering from venous, arterial and mixed skin ulcers and surgical dehiscence lesions;
- Presence of similar multiple lesions or lesions larger than 5 cm ;
- The patient must be able to understand the aims of the clinical study and provide informed consent in writing;
- Chronicity of the lesion: at least 8 weeks.
Exclusion
- Patients who participated in a clinical study on skin ulcers healing during the previous month;
- Patients who are unable to understand the aims and the objectives of the study;
- Patients with neoplastic ulcers;
- Patients with decubitus ulcers;
- Patients with diabet foot ulcers;
- Patients with infected ulcers;
- Patients with ulcers caused by critical ischemia;
- Patients with a past of self-harm that can purposely alter the progress of healing;
- Patients with psychiatric disorders;
- Pregnancy or breast feeding ;
- Patients with neoplasms or other diseases involving the use of cytostatic or immunosuppressive drugs;
- Patients with limited lifespan.
Key Trial Info
Start Date :
April 4 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 22 2019
Estimated Enrollment :
90 Patients enrolled
Trial Details
Trial ID
NCT04018924
Start Date
April 4 2018
End Date
December 22 2019
Last Update
May 19 2021
Active Locations (7)
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1
Ospedale Umberto I-Wound and Diabetic foot ambulatory
Bari, Italy, 70033
2
Barbantini Clinic
Lucca, Italy, 55100
3
Lucca Hospital
Lucca, Italy
4
Policlinico G. Martino
Messina, Italy, 98124