Back to resultsEvaluation of the Effect of the AI500™ SINGLE-DOSE GEL Medical Device in Patients With Reduced Knee Function
Primary Purpose
Pain, Acute, Pain, Chronic, Knee Injuries
Status
Completed
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
AI 500™ SINGLE-DOSE GEL
Sponsored by
About this trial
This is an interventional treatment trial for Pain, Acute focused on measuring Knee, Pain, Hyaluronic Acid, Peptides, Non-invasive
Eligibility Criteria
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.
Sites / Locations
- Humanitas Research Hospital
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
AI500 single-dose gel
Arm Description
Interventional study on AI500 1.5 mL will be topically administered twice: the first at T0 and the second 24h from T0
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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.
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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05886608
Brief Title
Evaluation of the Effect of the AI500™ SINGLE-DOSE GEL Medical Device in Patients With Reduced Knee Function
Official 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
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Completed
Study Start Date
August 30, 2022 (Actual)
Primary Completion Date
March 16, 2023 (Actual)
Study Completion Date
March 16, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Contrad Swiss SA
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Evaluation of the effect of the AI500™ SINGLE-DOSE GEL medical device in patients with reduced knee function
Detailed Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Acute, Pain, Chronic, Knee Injuries, Knee Osteoarthritis, Knee Arthritis, Knee Pain Swelling
Keywords
Knee, Pain, Hyaluronic Acid, Peptides, Non-invasive
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
35 (Actual)
8. Arms, Groups, and Interventions
Arm Title
AI500 single-dose gel
Arm Type
Other
Arm Description
Interventional study on AI500 1.5 mL will be topically administered twice: the first at T0 and the second 24h from T0
Intervention Type
Device
Intervention Name(s)
AI 500™ SINGLE-DOSE GEL
Intervention Description
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 Outcome Measure Information:
Title
Clinical performance of AI500™ SINGLE DOSE GEL in improving knee function after 1 week
Description
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.
Time Frame
1 Week
Secondary Outcome Measure Information:
Title
Clinical performance of AI500™ SINGLE DOSE GEL in improving knee function after 48 hours
Description
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.
Time Frame
2 days
Title
Clinical performance of AI500™ SINGLE DOSE GEL in alleviating pain after 24h and 48h of treatment.
Description
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.
Time Frame
2 days
Title
Safety and Tolerability of AI500™ SINGLE DOSE GEL
Description
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
Time Frame
1 week
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Humanitas Research Hospital
City
Rozzano
State/Province
Milano
ZIP/Postal Code
20089
Country
Italy
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Evaluation of the Effect of the AI500™ SINGLE-DOSE GEL Medical Device in Patients With Reduced Knee Function
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