EmoLED Medical Device Treatment of Second and Third Stage Pressure Ulcers

NCT05130814 | Completed Results

• 1 other identifier: EmoLED_005
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief Summary

The present clinical study aims to verify the effectiveness and safety of the blue light photobiomodulation therapy with EmoLED medical device in supporting the reparative process of the area of the second and third stage decubitus lesion, comparing this method with the effectiveness of the therapy commonly used in the clinical field.

Conditions

Pressure Sore; Pressure Ulcer; Pressure Ulcers Stage III; Pressure Ulcers Stage II

Keywords

ulcer; pressure ulcer; pressure sore; blue light; wound healing; EmoLED; photobiomodulation; LED

Outcome Measures

Primary Outcomes (1)

• Percentage Difference in PUSH Score

  Change in the index of the PUSH scale of second and third stage ulcers (reflecting the assessment of the clinical state of the lesions) in the two treatment groups at the end of the 4-week observation period. PUSH (Pressure Ulcer Scale for Healing) score is the sum of three subscales measuring wound size (0 to 10), exudate amount (0 to 3) and tissue type (0 to 4). The sum total ranges from 0 (best outcome) to 17 (worst outcome).The change in PUSH scale scores is determined by comparing the mean value at baseline with the final (4-weeks) mean value of the scores obtained for each arm. The comparison was performed by calculating the percentage reduction of the two values; this means that a positive percentage indicates a reduction in the mean values of the PUSH scale and a consequent improvement of the ulcer.

  4 weeks

Secondary Outcomes (2)

• Change of the Lesion Area

  4 weeks

• Number of Treatment-Emergent Adverse Events

  4 weeks

Study Arms (2)

Control Group

ACTIVE COMPARATOR

The Control Group will follow the standard treatment indicated three times a week for the 4 weeks of observation. The standard treatment for 2° and 3° stage PU consists of: cleansing with saline or ringer's lactate, hyaluronic acid gauze plus polyurethane foam every 48 hours or as needed. In addition, zinc cream or hyaluronic acid sodium salt + metallic silver is applied to prevent and/or treat the skin maceration of the surrounding area, and eventual debridement of the lesion, application of topical treatment indicated for that stage of the lesion (as provided by the "Protocol on pressure ulcers' dressing" intended as the "standard of care" of the structure) and subsequent bandage (that generally consists of a polyurethane film -thin hydrocolloid plate or a pressure discharge system made with hydrocolloids and polyurethane foam, known as "pressure relief system"), are planned.

Procedure: cleansing; Combination Product: hyaluronic acid gauze plus polyurethane foam; Drug: zinc cream or hyaluronic acid sodium salt + metallic silver; Procedure: topical treatment; Procedure: bandage

EmoLED Group

EXPERIMENTAL

The Experimental Group will undergo, in addition to the standard treatment, treatment with Emoled three times a week for 4 consecutive weeks. This treatment consists of irradiation with the blue light emitted by the device for one minute on the injured area. If the lesion has a greater extension than the irradiated area, multiple repeated applications will be performed, on adjacent areas, until the entire area is covered. The treatment with EmoLED will be carried out in correspondence with the dressing change of the lesion.

Device: blue light photobiomodulation; Procedure: cleansing; Combination Product: hyaluronic acid gauze plus polyurethane foam; Drug: zinc cream or hyaluronic acid sodium salt + metallic silver; Procedure: topical treatment; Procedure: bandage

Interventions

blue light photobiomodulation DEVICE

1 minute irradiation of blue light performed with EmoLED device.

Also known as: EmoLED treatment

EmoLED Group

cleansing PROCEDURE

cleaning of the wound area with saline or ringer's lactate

Control Group; EmoLED Group

hyaluronic acid gauze plus polyurethane foam COMBINATION_PRODUCT

every 48 hours or as needed

Control Group; EmoLED Group

zinc cream or hyaluronic acid sodium salt + metallic silver DRUG

applied to prevent and/or treat the skin maceration of the surrounding area

Control Group; EmoLED Group

topical treatment PROCEDURE

topical treatment indicated for that stage of the lesion

Control Group; EmoLED Group

bandage PROCEDURE

it consists of a polyurethane film -thin hydrocolloid plate or a pressure discharge system made with hydrocolloids and polyurethane foam, known as "pressure relief system"

Control Group; EmoLED Group

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with 2° or 3° stage lower limb/ sacrum located pressure ulcers;
• Patients with 2° or 3° stage pressure ulcers with a ≥ 2cm² lesion area;
• Patients with a hospitalization waiting time \< 30 day;
• Men and women aged ≥ 50 years;
• Patients with a Braden scale score ≥ 11;

You may not qualify if:

• Patients who are participating in other clinical trials with drug or medical device;
• Patients with third stage pressure lesions, on the lower limbs or on the sacrum, with undermining wounds, tunneling or eschar;
• Patients with systemic or superficial infection at the time of recruitment, that need systemic antibiotic therapy;
• Patients with a history of self-harm who can voluntarily alter the course of healing;
• Patients under intravenous therapy with doses of corticosteroids above 40mg/day;
• Patients under immunosuppressant or cytostatic drugs therapy;
• Women who are pregnant or breastfeeding1;
• Patients with neoplasia;
• Patients with pathologies that induce skin photosensitivity;
• Patients with a life expectancy of less than 30 days.

Sponsors & Collaborators

• Emoled: lead

Study Sites (1)

IRCCS Don Carlo Gnocchi

Florence, 50143, Italy

Location

Related Publications (1)

• Dollaku H, Dalladonna M, Giuliano M, Rossi M, Barbetti P, Marcolongo MS, Buccione E, Iovino P, Macchi C. Randomized clinical trial of the efficacy of the EmoLED medical device in the treatment of stage 2 and stage 3 pressure ulcers: The RISE_UP study. J Tissue Viability. 2025 Aug;34(3):100895. doi: 10.1016/j.jtv.2025.100895. Epub 2025 Mar 26.

  PMID: 40158347 DERIVED

MeSH Terms

Conditions

Pressure Ulcer; Ulcer

Interventions

polyurethane foam; Therapeutics; Bandages

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Equipment and Supplies

Results Point of Contact

• Title: Duccio Rossi Degl'Innocenti
• Organization: Emoled srl

d.rossi@emoled.com

+390550751960

Study Officials

• Stefano Gasperini

  Medical Advisor

  STUDY DIRECTOR

• Claudio Macchi

  IRCCS Don Carlo Gnocchi

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

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

Study Record Dates

• First Submitted: November 11, 2021
• First Posted: November 23, 2021
• Study Start: December 1, 2021
• Primary Completion: March 7, 2024
• Study Completion: March 7, 2024
• Last Updated: January 28, 2025
• Results First Posted: January 28, 2025

Record last verified: 2024-10

Locations

IT (1)