Leg Ulcers Standards of Care Enhancement (LUCE)
Venous Leg Ulcer, Mixed Leg Ulcer
About this trial
This is an interventional treatment trial for Venous Leg Ulcer focused on measuring leg ulcer, photobiomodulation, blue light, wound healing
Eligibility Criteria
Inclusion Criteria:
- 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 Criteria:
- 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;
Sites / Locations
- Ospedale Briolini, ASST Bergamo ESTRecruiting
- Ospedale Felice LottiRecruiting
- Geriatrics Unit, Presidio Ospedaliero di Rete San Bassiano, ULSS 7 PedemontanaRecruiting
- Dermatology Unit AOU Policlinico Sant'Orsola - MalpighiRecruiting
- Dermatology Unit, Azienda Ospedaliero Universitaria Pisana, Stabilimento di S. ChiaraRecruiting
Arms of the Study
Arm 1
Arm 2
Active Comparator
Experimental
SOC Group
EmoLED Group
SOC Group (or control group) will follow the standard therapy with visits twice a week. More specifically, the treatment consists of: dressing change, cleansing and eventual debridement of the lesion, the topic treatment and compression bandage.
EmoLED Group will be visited once a week. Therapy in this case includes, in addition to the standard therapy, a treatment with EmoLED device; it consists in irradiating each 5 cm diameter area of the lesion for 60 seconds, with the blue light emitted by the device. For lesions larger than 5 cm, several applications will be applied on adjacent areas, until the whole lesion is covered.