Pressure Ulcer Clinical Trial
— RISE_UPOfficial title:
Perspective Randomized Study Aimed at Evaluating the Effectiveness of the EmoLED Medical Device in the Treatment of Second and Third Stage Pressure Ulcers
Verified date | June 2024 |
Source | Emoled |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 48 |
Est. completion date | March 7, 2024 |
Est. primary completion date | March 7, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 50 Years and older |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
Italy | IRCCS Don Carlo Gnocchi | Firenze |
Lead Sponsor | Collaborator |
---|---|
Emoled |
Italy,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. | 4 weeks | |
Secondary | 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 | 4 weeks | |
Secondary | 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 |
4 weeks |
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