Leg Ulcers Standards of Care Enhancement

Summary

Multi-center, prospective,randomized controlled study on the speed of healing, life quality and cost-effectiveness of the treatment with a blue light medical device (EmoLED) versus existing Standards Of Care (SOC) for patients with leg ulcers.

The aim of LUCE - "Leg Ulcers Standards of Care Enhancement" clinical trial is to verify the clinical efficacy of a portable battery-powered device blue LEDs based. This study aims to compare the existing SOC (consisting in two visits per week) to a protocol that requires only one visit per week, during which the EmoLED treatment is administered in addition to the current therapy.

It is expected to register a difference in efficacy between EmoLED Group and SOC Group, in terms of "healing rate", intended as a reduction of the wound area, but also as a progress, in a broad sense, of the overall clinical situation of the lesion, in terms of pain and quality of life.

-Endpoint- The primary endpoint is the comparison of the outcomes in terms of healing rate of lesions treated with SOC (SOC Group) versus lesions treated with EmoLED (EmoLED Group), on week 16th.

Patients 80 patients will be recruited (40 patients per group), following these inclusion/exclusion 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;
* Pregnancy or breast feeding;
* Patients with neoplasms or other diseases involving the use of cytostatic or immunosuppressive drugs;
* Patients with limited lifespan;
* Patients with photosensitizing illnesses or that take photosensitizing drugs. All inclusion and exclusion criteria must be satisfied before recruitment. Any concomitant phar-macological therapy must be maintained.

-Medical and surgical procedures- The lesions will be cleansed with saline solution and, if necessary, surgical debridement will be performed with the most suitable method. At this point, if patient is included in EmoLED Group, the EmoLED treatment starts. After EmoLED application (EmoLED Group) or after cleansing (SOC Group), a polyurethane foam dressing will be applied on the lesion. In case of clinical signs of infection, a silver dressing will be applied.

Then an elasto-compressive double layer dressing of the limb with cohesive fixation bielastic la-tex-free bandage will be carried out.

The treatment with EmoLED, in addition to the SOC, will be performed during each visit for 60 seconds on each 5 cm diameter sub-area of the selected lesion.

In case of multiple lesions matching with both inclusion and exclusion criteria, they will be all treated following the same protocol, depending on the group to which the patient belongs; in this case the Principal Investigator will fill out a data-collection form and take pictures just of the le-sion with the wider area.

-Follow up procedure- The patient is called upon to go to the follow-up check after 4 weeks from the healing or, other-wise, from the end of the trial (16 weeks). The follow-up visit will be used to confirm the occurred healing and verify the absence of relapses and/or undesirable effects (if the wound appeared completely healed) or to value the healing progress for the unhealed lesions.

Conditions

• Venous Leg Ulcer
• Mixed Leg Ulcer

Interventions

DEVICE

EmoLED

The treatment with EmoLED, in addition to the SOC, will be performed during each visit for 60 seconds on each 5 cm diameter sub-area of the selected lesion.

PROCEDURE

current Standards Of Care

The lesions will be cleansed with saline solution and, if necessary, surgical debridement will be performed with the most suitable method. At this point, if patient is included in EmoLED Group, the EmoLED treatment starts. After EmoLED application (EmoLED Group) or after cleansing (SOC Group), a polyurethane foam dressing will be applied on the lesion. In case of clinical signs of infection, a silver dressing will be applied. Then an elasto-compressive double layer dressing of the limb with cohesive fixation bielastic latex-free bandage will be carried out.

Sponsors & Collaborators

• Emoled

  lead INDUSTRY

Principal Investigators

• Marco Romanelli, MD · Azienda Ospedaliero, Universitaria Pisana

• Stefano Gasperini, MD · Medical Advisor

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2019-05-14

Primary Completion

2024-02-29

Completion

2024-02-29

Countries

• Italy

Study Locations