Blu Light for Ulcers Reduction

Summary

Multi-center study on the effectiveness of treatment with a blue light medical device (EmoLED) in the reduction of ulcer surface in 10 weeks.

The aim of BLUR clinical trial is to verify if the proposed treatment represents a valid and significant remedy for Chronic Venous Insufficiency ulcers. The effectiveness will be measured through the evaluation of the reduction percentage of the lesion area during 10 weeks of treatment comparing the lesion (or portion of it) treated with EmoLED versus the control lesion (or portion of it) treated only according to current Standards of Care(SOC).

In the 10 weeks following the recruitment, the patient continues to follow the usual topical therapy with a frequency of once a week visit. The patient will be monitored up to the first event occurring: Complete healing or ten weeks. During the study, reports and evaluations will be made by medical staff on the device safety and usability.

90 patients will be recruited corresponding to the following criteria:

* Subjects suffering from venous, arterial and mixed skin ulcers and surgical dehiscence lesions;
* Presence of similar multiple lesions or lesions larger than 5 cm ;
* Men and women ≥ 18 years old;
* The patient must be able to understand the aims of the clinical study and provide informed consent in writing;
* Chronicity of the lesion: at least 8 weeks. The present clinical trial will be a multi-center prospective, controlled study with the aim of verifying the clinical efficacy of a portable battery-powered device based on blue LEDs.

We expect to record at least 20% of the difference between treated lesion and untreated lesion on the same patient during observation time.

The treatment, additional to the standard therapy for the patient, will be performed at each visit for 60 seconds on each 5 cm diameter sub-area of the selected lesion or on part of it.

In case of multiple lesions, one will be treated with EmoLED and one will be selected as a control lesion. In case of a very extensive lesion, it will be divided into two and one half will be the control of the other.

All lesions will be cleansed with saline solution and a surgical debridement will be performed with a scalpel if a slough/black base is present. Only then the treatment with EmoLED will begin.

If the patient has more than one lesion at the recruitment time, and all lesions are less than 5 cm in diameter, the worst lesions will be treated entirely with the EmoLED device and the others will constitute the control lesions. The evolution of all lesions in the ten weeks of the study duration will be evaluated.

If the patient has only one lesion greater than 5 cm in diameter at the recruitment time, the lesion will be divided into two parts along the major side and one half of the lesion area will be treated. The other half of the lesion will be masked with multi-layered sterile gauze during treatment. The point of division of the lesion into two parts will be indicated with an indelible marker and retouched at each visit.

If, at the time of recruitment, the patient has more than one lesion with a diameter greater than 5 cm, all lesions will be divided into two along the major side and will be treated as in the previous case.

After treatment with EmoLED, a hydrofiber dressing will be applied to the lesion. If clinical signs of infection occur, a hydrofiber dressing with silver will be applied. If necessary, compressive bandage of the limb will be carried out.

Conditions

• Leg Ulcers Venous
• Dehiscence, Surgical Wound

Interventions

DEVICE

Illumination with blue light (400-430nm) for 60 seconds with a power density of 120mW/sqcm (EmoLED device)

Debridement and Dressing or compressive dressing if needed

Sponsors & Collaborators

• Akros Bioscience

  collaborator INDUSTRY

• Phidea Group

  collaborator INDUSTRY

• Istituto di Fisiologia Clinica CNR

  collaborator OTHER

• University of Pisa

  collaborator OTHER

• Emoled

  lead INDUSTRY

Principal Investigators

• Marco Fraccalvieri, Doctor · A.O.U. Città della Salute e della Scienza

• Stefano Gasperini, Doctor · Medical Advisor

Study Design

Allocation

NA

Purpose

TREATMENT

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Max Age

99 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2018-04-04

Primary Completion

2019-11-17

Completion

2019-12-22

Countries

• Italy

Study Locations