Effectiveness of the EmoLED Medical Device in the Healing of Digital Ulcers in Patients With Scle… (NCT05181644) | Clinical Trial Compass
TerminatedNot Applicable
Effectiveness of the EmoLED Medical Device in the Healing of Digital Ulcers in Patients With Scleroderma.
Stopped: Failure to reach the expected number of patients
Italy36 participantsStarted 2022-04-22
Plain-language 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 as the complete re-epithelization of the wound) and the perception of pain through NRS scale.
Who can participate
Age range
16 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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 Criteria:
* 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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.