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EmoLED Medical Device Treatment of Second and Third Stage Pressure Ulcers (RISE_UP)

Primary Purpose

Pressure Sore, Pressure Ulcer, Pressure Ulcers Stage III

Status
Recruiting
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
blue light photobiomodulation
cleansing
hyaluronic acid gauze plus polyurethane foam
zinc cream or hyaluronic acid sodium salt + metallic silver
topical treatment
bandage
Sponsored by
Emoled
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pressure Sore focused on measuring ulcer, pressure ulcer, pressure sore, blue light, wound healing, EmoLED, photobiomodulation, LED

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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;

Exclusion Criteria:

  • 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.

Sites / Locations

  • IRCCS Don Carlo GnocchiRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Control Group

EmoLED Group

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Ulcers' clinical state
The assessment of the clinical state of second and third stage ulcers by changing the index of the PUSH scale (in which 0 is the minimum value and best result, as it means the wound has healed) in the two treatment groups at the end of the 4-week observation period.

Secondary Outcome Measures

Change of the lesion surface in both arms, measured as % of the initial size.
The assessment, during the weeks of observation, of the percentage of reduction of the lesion area compared to V0 in the second and third stage lesions in the two treatment groups
Number of Treatment-Emergent Adverse Events
Safety of treatment (number of related adverse events in the two groups). All incidents according to the definition of the EU regulation 2017/745 on Medical Devices will be properly reported their gravity and relation with the therapy evaluated. It will be counted the number and gravity of occurred adverse events on both arms

Full Information

First Posted
November 11, 2021
Last Updated
September 25, 2023
Sponsor
Emoled
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1. Study Identification

Unique Protocol Identification Number
NCT05130814
Brief Title
EmoLED Medical Device Treatment of Second and Third Stage Pressure Ulcers
Acronym
RISE_UP
Official Title
Perspective Randomized Study Aimed at Evaluating the Effectiveness of the EmoLED Medical Device in the Treatment of Second and Third Stage Pressure Ulcers
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
December 1, 2021 (Actual)
Primary Completion Date
June 2024 (Anticipated)
Study Completion Date
June 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Emoled

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.
Detailed Description
Pressure ulcers (PU), also known as decubitus sores, are areas of lesion localized to the skin and subcutaneous tissue. The development of decubitus ulcers occurs in institutional and community environments, and more frequently in assisted elderly, debilitated and motionless (e.g. orthopedic patients), in patients with severe acute disease (e.g. hospitalized in intensive care units) and in subjects with neurological deficits (e.g. spinal injuries). Recognizing the considerable economic, health and social impact of pressure ulcers has led to considerable efforts to reduce their occurrence. Nevertheless, pressure ulcers continue to occur. Although not all pressure ulcers are iatrogenic, most of them can be prevented. Pressure ulcers are one of the most frequent iatrogenic lesions in developed countries. Inadequate treatment methods, such as leaving vulnerable patients in potentially harmful positions for long periods, or massaging reddened skin areas, often continue to be perpetuated even if it has been proven that they are damaging or ineffective. Pressure, that is often associated to a limitation in mobility of the patient, for a long time has been considered the most important extrinsic factor in the development of pressure ulcers. However, recent research, and still ongoing, is revealing that shear forces, friction, and microclimate also play an important role in the etiology of pressure ulcers, and that, also, some significant and complex relationships between all these extrinsic factors exist. In alert patients, the effects of prolonged pressure usually stimulate frequent light body movements to relieve the load and restore tissue perfusion. Unconscious, sedated, anesthetized or paralyzed patients cannot feel or respond to these stimuli and do not move spontaneously. As a result, skin and soft tissue can be exposed to prolonged and without relief pressure. PUs are generally more common in anatomical locations that cover a bone prominence. In adults, the most common sites are the sacrum and the heel. Other frequently affected anatomical locations are ischium, ankle, elbow and hip. Pressure ulcers are often difficult to diagnose, in particular it is easy to confuse them with moisture-caused injuries. A correct diagnosis is essential to determine both prevention and treatment plans. For a proper management of pressure lesions it is essential to take into account their characteristics (location, color, size, amount of exudate, type of tissue, smell, edges) and to consider the condition of the peri-lesional skin (erythema, edema, hardening, maceration). To describe the state of a pressure ulcer, EPUAP (European Pressure Ulcer Advisory Panel) and NPUAP (National Pressure Ulcer Advisory Panel) recommend to divide pressure injuries stages from 1 to 4: Stage 1 - Persistent erythema Intact skin with redness not reversible to acupressure in a localized area, usually above a bone prominence. Stage 1 may indicate a patient at risk. Stage 2 - Partial thickness tissue loss Loss of the dermis at partial thickness, which looks like a shallow and open ulcer, with red - pinkish lesion bed, without slough. It may also present as a vesicle, intact or open/broken, serous and/or haematic. Stage 3 - Total Thickness Tissue Loss Loss of tissue at total thickness. Subcutaneous fat may be visible, but bones, tendons or muscles are not exposed. There may be slough, which does not hide the depth of tissue loss. It may include undermining wounds and tunneling. Stage 4 - Loss of subcutaneous tissue Loss of tissue at total thickness with exposure of bones, tendons or muscles. There may be slough or eschar on some parts of the lesion bed. Undermining wounds and tunneling are often present. Stage 4 injuries can extend to muscle and to support structures. Not classifiable lesion Loss of tissue at total thickness, where the base of the ulcer is covered by slough (yellow, brown, grey, green or brown) and/or eschar (brown, brown or black) in the bed of the lesion. The commercial purpose of this study is to value the clinical efficacy of a battery-powered device that uses blue LEDs. The study aims to compare the response of an existing standard treatment for second and third stage pressure sores, with a protocol that plans the administration of the EmoLED treatment three times a week for 4 consecutive weeks in addition to the conventional therapy. The Study has an indicative duration of 12 months with an expected enrollment period of 10 months. The study, however, will continue until the number of patients required by this protocol is reached.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Control Group
Arm Type
Active Comparator
Arm Description
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.
Arm Title
EmoLED Group
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
blue light photobiomodulation
Other Intervention Name(s)
EmoLED treatment
Intervention Description
1 minute irradiation of blue light performed with EmoLED device.
Intervention Type
Procedure
Intervention Name(s)
cleansing
Intervention Description
cleaning of the wound area with saline or ringer's lactate
Intervention Type
Combination Product
Intervention Name(s)
hyaluronic acid gauze plus polyurethane foam
Intervention Description
every 48 hours or as needed
Intervention Type
Drug
Intervention Name(s)
zinc cream or hyaluronic acid sodium salt + metallic silver
Intervention Description
applied to prevent and/or treat the skin maceration of the surrounding area
Intervention Type
Procedure
Intervention Name(s)
topical treatment
Intervention Description
topical treatment indicated for that stage of the lesion
Intervention Type
Procedure
Intervention Name(s)
bandage
Intervention Description
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"
Primary Outcome Measure Information:
Title
Ulcers' clinical state
Description
The assessment of the clinical state of second and third stage ulcers by changing the index of the PUSH scale (in which 0 is the minimum value and best result, as it means the wound has healed) in the two treatment groups at the end of the 4-week observation period.
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
Change of the lesion surface in both arms, measured as % of the initial size.
Description
The assessment, during the weeks of observation, of the percentage of reduction of the lesion area compared to V0 in the second and third stage lesions in the two treatment groups
Time Frame
4 weeks
Title
Number of Treatment-Emergent Adverse Events
Description
Safety of treatment (number of related adverse events in the two groups). All incidents according to the definition of the EU regulation 2017/745 on Medical Devices will be properly reported their gravity and relation with the therapy evaluated. It will be counted the number and gravity of occurred adverse events on both arms
Time Frame
4 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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; Exclusion Criteria: 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Duccio Rossi Degl'Innocenti
Phone
0550751981
Email
d.rossi@emoled.com
First Name & Middle Initial & Last Name or Official Title & Degree
Magalì Mafucci
Phone
055 0751978
Email
m.mafucci@emoled.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stefano Gasperini
Organizational Affiliation
Medical Advisor
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Claudio Macchi
Organizational Affiliation
IRCCS Don Carlo Gnocchi
Official's Role
Principal Investigator
Facility Information:
Facility Name
IRCCS Don Carlo Gnocchi
City
Firenze
ZIP/Postal Code
50143
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Claudio Macchi, Doctor
Phone
055 7393909
Email
cmacchi@DONGNOCCHI.IT
First Name & Middle Initial & Last Name & Degree
Claudio Macchi, Doctor

12. IPD Sharing Statement

Learn more about this trial

EmoLED Medical Device Treatment of Second and Third Stage Pressure Ulcers

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