Evaluation of the Effect of the AI500™ SINGLE-DOSE GEL Medical Device in Patients With Reduced Knee Function

Study Overview
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Brief Summary
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Evaluation of the effect of the AI500™ SINGLE-DOSE GEL medical device in patients with reduced knee function

Detailed Description
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The aim of this post-market confirmatory interventional clinical investigation is to evaluate the performance and safety of AI500™ SINGLE-DOSE GEL in patients with reduced knee function.

Official Title
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Evaluation of the Effect of the AI500™ SINGLE-DOSE GEL Medical Device in Patients With Reduced Knee Function: a Post-market Confirmatory Interventional, Single Arm Clinical Investigation

Conditions
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Pain, Acute, Pain, Chronic, Knee Injuries, Knee Osteoarthritis, Knee Arthritis, Knee Pain Swelling

Intervention / Treatment
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* Device: AI 500™ SINGLE-DOSE GEL


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Signed patient informed consent form (ICF). Male or Female aged ≥ 18 years at the time of the signature of ICF. Presenting with reduced knee function caused by osteoarthritis flare-ups, meniscal injuries, ligament injuries, inflammation of soft tissues, assessed as 20-45 rating according to the WOMAC function scale. Willingness to follow all study procedures, including attending all site visits, tests, and examinations. Willingness to follow indications. Exclusion Criteria: Use of analgesics within the 24 hours prior to V0. Damaged, infected, or ulcerated skin in the area of treatment. Ongoing cutaneous allergies. Serious and chronic pathological skin conditions (i.e., rosacea, psoriasis, vitiligo) or lesions including cancer with/without ongoing antitumor therapy. Patients suffering from muscular dystrophy. Patients presenting with bone fractures or severe injuries (including locked knee). Severely disabled arthritic patients using a wheelchair. Allergy to device components (Sodium hyaluronate; SHPolypeptide- 6; Glycerin; Propylene glycol; Ethylhexylglycerin; Panthenol; PEG-40 hydrogenated castor oil; Sodium hydroxide; Xanthan gum; Phenoxyethanol; Benzoic Acid; Carbomer; Dehydroacetic Acid; Disodium EDTA). Immune system illnesses. Uncontrolled systemic diseases. Known drug and/or alcohol abuse. Mental incapacity that precludes adequate understanding or cooperation. Participation in another investigational study. Pregnancy or breastfeeding. Patients with both knees affected/damaged.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: AI500 single-dose gel<br>Interventional study on AI500 1.5 mL will be topically administered twice: the first at T0 and the second 24h from T0 | Device: AI 500™ SINGLE-DOSE GEL<br>* AI500™ SINGLE-DOSE GEL is a hydrogel to be applied to intact skin, intended to provide relief in cases of pain due to tension in muscles and adjacent tissues, to improve movement and function.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical performance of AI500™ SINGLE DOSE GEL in improving knee function after 1 week | To evaluate the clinical performance of AI500™ SINGLE DOSE GEL in improving knee function after 1 week of treatment, change from baseline (V0) to week 1 (V3) in Western Ontario and McMasters Universities Osteoarthritis Index (WOMAC) Physical Function score will be evaluated. The test questions are scored on a scale of 0-4, which correspond to: None (0), Mild (1), Moderate (2), Severe (3), and Extreme (4). The scores for each subscale are summed up, with a possible score range of 0-20 for Pain, 0-8 for Stiffness, and 0-68 for Physical Function. | 1 Week | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical performance of AI500™ SINGLE DOSE GEL in improving knee function after 48 hours | To evaluate the clinical performance of AI500™ SINGLE DOSE GEL in improving knee function after 48 hours of treatment, change from baseline to 48 hours (V2) in WOMAC Physical Function score will be evaluated. The test questions are scored on a scale of 0-4, which correspond to: None (0), Mild (1), Moderate (2), Severe (3), and Extreme (4). The scores for each subscale are summed up, with a possible score range of 0-20 for Pain, 0-8 for Stiffness, and 0-68 for Physical Function. | 2 days | 
| Clinical performance of AI500™ SINGLE DOSE GEL in alleviating pain after 24h and 48h of treatment. | To evaluate the clinical performance of AI500™ SINGLE DOSE GEL in alleviating pain after 24h and 48h of treatment, change in NRS between V0 and V1, and between V0 and V2 will be analysed. NRS Score has a range of 0-10 for pain; 0=no pain; 10=max pain. | 2 days | 
| Safety and Tolerability of AI500™ SINGLE DOSE GEL | To evaluate the safety and tolerability of AI500™ SINGLE DOSE GEL, physical examination and adverse events (AEs), including of the relationship of the AE to the IP (e.g., local allergic reaction), will be assessed through the study. Safety and tolerability of the AI500™ will be evaluated through a the completion of a specific questionnaire by the patient, the five-points Likert scale in which 1 means Strongly disagree with the assertion and 5 means Strongly agree | 1 week | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hyaluronic Acid, Peptides, Knee, Pain, Non-invasive