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

NCT05886608 | Completed DMC

• 1 other identifier: CTD-SW AI500 2021
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

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

Keywords

Knee; Pain; Hyaluronic Acid; Peptides; Non-invasive

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Clinical performance of AI500™ SINGLE DOSE GEL in improving knee function after 48 hours

  2 days

• Clinical performance of AI500™ SINGLE DOSE GEL in alleviating pain after 24h and 48h of treatment.

  2 days

• Safety and Tolerability of AI500™ SINGLE DOSE GEL

  1 week

Study Arms (1)

AI500 single-dose gel

OTHER

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

Interventions

AI 500™ SINGLE-DOSE GEL DEVICE

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.

AI500 single-dose gel

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Contrad Swiss SA: lead

Study Sites (1)

Humanitas Research Hospital

Rozzano, Milano, 20089, Italy

Location

MeSH Terms

Conditions

Acute Pain; Chronic Pain; Knee Injuries; Osteoarthritis, Knee; Pain

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Leg Injuries; Wounds and Injuries; Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Design

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

Study Record Dates

• First Submitted: May 12, 2023
• First Posted: June 2, 2023
• Study Start: August 30, 2022
• Primary Completion: March 16, 2023
• Study Completion: March 16, 2023
• Last Updated: June 2, 2023

Record last verified: 2023-05

Locations

IT (1)