Status:
TERMINATED
Effectiveness of the EmoLED Medical Device in the Healing of Digital Ulcers in Patients With Scleroderma.
Lead Sponsor:
Emoled
Conditions:
Ulcer
Acral Nevus
Eligibility:
All Genders
16+ years
Phase:
NA
Brief Summary
The present clinical study aims to compare, in the two groups of patients with acral ulcers, the reparative process of the injured area, the evaluation of the healing time (with "healing" interpreted ...
Detailed Description
This clinical study will be a prospective, randomized controlled study, with the commercial objective of assessing the clinical effectiveness of a portable battery powered device that uses blue LED. ...
Eligibility Criteria
Inclusion
- Subjects suffering from systemic sclerosis with at least an ulcerative lesion on the fingers of the upper limbs;
- The ulcer must not present bone or tendon exposure;
- Chronicity of the lesion: at least 4 weeks;
- Men and women aged ≥ 18 years;
- The patient must be able to understand the purposes of the clinical trial and provide informed consent in writing.
Exclusion
- Patients who are participating in other clinical trials with drug or medical device;
- Patients with a history of self-harm who can voluntarily alter the course of healing;
- Women who are pregnant or breastfeeding1;
- Patients who participated in a clinical study on the healing of skin ulcers during the previous month;
- Patients who are unable to understand the purposes and objectives of the study;
- Presence of infectious signs according to IDSA criteria at the time of recruitment;
- Presence of peripheral vascular obstructive diseases;
- Patients with psychiatric disorders;
- Patients with neoplasia;
- Patients with pathologies that induce skin photosensitivity;
- Patients with a limited life expectancy.
Key Trial Info
Start Date :
April 22 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 6 2024
Estimated Enrollment :
36 Patients enrolled
Trial Details
Trial ID
NCT05181644
Start Date
April 22 2022
End Date
March 6 2024
Last Update
June 7 2024
Active Locations (1)
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1
AOU Careggi - SOD Reumatologia - Scleroderma Unit
Florence, Italy, 50134