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Completed

NCT Number: NCT05886608

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

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

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Key information

Conditions

Pain, Acute Acute Pain Arthritis Chronic Pain Joint Diseases Knee Arthritis Knee Injuries Knee Osteoarthritis Knee Pain Swelling Leg Injuries Musculoskeletal Diseases Neurologic Manifestations Osteoarthritis Osteoarthritis, Knee Pain Pain, Chronic Pathological Conditions, Signs and Symptoms Rheumatic Diseases Signs and Symptoms Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Humanitas Research Hospital

Rozzano, Milano, 20089, Italy

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. Clinical performance of AI500™ SINGLE DOSE GEL in improving knee function after 1 week

    Time frame: 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.

Secondary outcomes

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

    Time frame: 2 days

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

    Time frame: 2 days

    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.

  3. Safety and Tolerability of AI500™ SINGLE DOSE GEL

    Time frame: 1 week

    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

Sponsors and collaborators

Lead sponsor

Contrad Swiss SA

Industry

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Jun 2, 2023
Registry last updated
Jun 2, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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