Effectiveness of the EmoLED Medical Device in the Healing of Digital Ulcers in Patients With Scleroderma.

NCT05181644 | Terminated

• 1 other identifier: EmoLED_004
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

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 as the complete re-epithelization of the wound) and the perception of pain through NRS scale.

Conditions

Ulcer; Acral Nevus; Scleroderma; Digital Ulcer

Keywords

ulcer; acral; scleroderma; EmoLED; wound healing; blue light; digital ulcer

Outcome Measures

Primary Outcomes (1)

• Number of healed lesions in the two groups

  The primary endpoint is the comparison of the outcomes in terms of number of patients with an acral lesion that reach healing (interpreted as the complete re-epitelization of the lesioned area) treated with the standard method (Control Group), versus the number of patients with an acral lesion treated with Emoled and the standard method (Treated Group), at the last visit of the sixteen weeks of observation.

  16 weeks

Secondary Outcomes (3)

• Healing time evaluation

  20 weeks

• Pain evaluation

  16 weeks

• Adverse events

  16 weeks

Study Arms (2)

Control Group

ACTIVE COMPARATOR

To the Control Group is administered the current standard therapy for 16 weeks.

Procedure: current Standard of Care

EmoLED Group

EXPERIMENTAL

The treatment with EmoLED will be carried out once a week in correspondence with the dressing change of the lesion, for sixteen consecutive weeks, for a total of 16 treatments.

Device: EmoLED treatment; Procedure: current Standard of Care

Interventions

EmoLED treatment DEVICE

Treatment with the EmoLED device consists of irradiating each area of 5 cm in diameter of the lesion for 60 seconds; if the lesion is larger than 5 cm in diameter, the applications will be repeated up to cover the entire area of interest. EmoLED treatment is additional to the standard therapy for the patient.

EmoLED Group

current Standard of Care PROCEDURE

The acral lesions will be cleansed with physiological solution, disinfected with a special device and, if necessary, a debridement will be carried out with the most appropriate method.

Control Group; EmoLED Group

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Emoled: lead

Study Sites (1)

AOU Careggi - SOD Reumatologia - Scleroderma Unit

Florence, 50134, Italy

Location

MeSH Terms

Conditions

Ulcer; Scleroderma, Diffuse; digital ulcers

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Scleroderma, Systemic; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Skin Diseases

Study Officials

• Stefano Gasperini, MD

  Medical Advisor

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Prospective, randomized controlled study. It is a 1:1 randomization, stratified, with 3 blocks of patients distributed in the two groups (experimental and control).

Study Record Dates

• First Submitted: December 20, 2021
• First Posted: January 6, 2022
• Study Start: April 22, 2022
• Primary Completion: March 6, 2024
• Study Completion: March 6, 2024
• Last Updated: June 7, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)