Leg Ulcers Standards of Care Enhancement

Launched by EMOLED · Dec 28, 2020

Keywords

ClinConnect Summary

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 individuals with skin lesions that are at least 16 old, regardless of their ethnicity. EmoLED is conceived and designed to treat chronic and acute lesions of the skin by healthcare professionals such as doctors and nurses; in particular the EmoLED treatment is part of the wound bed preparation.

EmoLED treatment is additional to the conventional therapy consisting in the lesions cleansing and dr...

Gender

ALL

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;