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

NCT05181644 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 36

Last updated 2024-06-07

No results posted yet for this study

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

Interventions

DEVICE

EmoLED treatment

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.

PROCEDURE

current Standard of Care

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.

Sponsors & Collaborators

  • Emoled

    lead INDUSTRY

Principal Investigators

  • Stefano Gasperini, MD · Medical Advisor

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
16 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-04-22
Primary Completion
2024-03-06
Completion
2024-03-06

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05181644 on ClinicalTrials.gov