Status:
COMPLETED
Leg Ulcers Standards of Care Enhancement
Lead Sponsor:
Emoled
Conditions:
Venous Leg Ulcer
Mixed Leg Ulcer
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Multi-center, prospective,randomized controlled study on the speed of healing, life quality and cost-effectiveness of the treatment with a blue light medical device (EmoLED) versus existing Standards ...
Detailed Description
EmoLED is CE marked as a phototherapy device for the treatment of skin lesions. It is intended for use by medical personnel in a hospital or outpatient setting. The patients' demographic consists of i...
Eligibility Criteria
Inclusion
- Subjects suffering from venous and mixed skin ulcers;
- Presence of a lesion \< 100 cm² of area and \< 1 cm in depth;
- Men and women ≥ 18 years old;
- The patient must be able to understand the aims of the clinical trial and provide informed consent in writing;
- Chronicity of the lesion: at least 8 weeks.
Exclusion
- Patients who participated in clinical trials about skin ulcers healing during the previous month;
- Patients who are not able to understand the aims of the trial;
- Patients with pressure ulcers;
- Patients with diabetic foot ulcers;
- Patients with circumferential leg ulcer (due to the difficulties in analysing the pictures);
- Patients with clearly infected ulcers or with systemic infection;
- Patients with ulcers caused by critical ischemia;
- Patients with a self-harm past that can purposely alter the process of healing;
- Patients with psychiatric disorders;
Key Trial Info
Start Date :
May 14 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 29 2024
Estimated Enrollment :
83 Patients enrolled
Trial Details
Trial ID
NCT04689009
Start Date
May 14 2019
End Date
February 29 2024
Last Update
May 9 2025
Active Locations (5)
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1
Ospedale Briolini, ASST Bergamo EST
Gazzaniga, Bergamo, Italy, 24025
2
Ospedale Felice Lotti
Pontedera, Pisa, Italy, 56025
3
Geriatrics Unit, Presidio Ospedaliero di Rete San Bassiano, ULSS 7 Pedemontana
Bassano del Grappa, Vicenza, Italy, 36061
4
Dermatology Unit AOU Policlinico Sant'Orsola - Malpighi
Bologna, Italy, 40138