Pain, AcuteNCT05886608
Evaluation of the Effect of the AI500™ SINGLE-DOSE GEL Medical Device in Patients With Reduced Knee Function
A study testing AI 500™ SINGLE-DOSE GEL in people with Pain, Acute and Pain, Chronic, run by Contrad Swiss SA at 1 site in Italy.
Trial summary
Evaluation of the effect of the AI500™ SINGLE-DOSE GEL medical device in patients with reduced knee function Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pain, Acute, Pain, Chronic, Knee Injuries
- What is being tested?
- AI 500™ SINGLE-DOSE GEL
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteItaly
- Study dates
- 30 Aug 2022to 16 Mar 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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).
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
Evaluation of the effect of the AI500™ SINGLE-DOSE GEL medical device in patients with reduced knee function
Read the 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.
- Conditions
- Pain, Acute, Pain, Chronic, Knee Injuries, Knee Osteoarthritis, Knee Arthritis, Knee Pain Swelling
- Being tested
- AI 500™ SINGLE-DOSE GEL
- Keywords
- Knee, Pain, Hyaluronic Acid, Peptides, Non-invasive
- Medical subject headings
- Acute Pain, Chronic Pain, Knee Injuries, Osteoarthritis, Knee, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AI 500™ SINGLE-DOSE GELDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Device: AI 500™ SINGLE-DOSE GEL |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 Week
Secondary outcomes (3)
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.
Measured: 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.
Measured: 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
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2023
- Study start30 Aug 2022
- Primary completion16 Mar 2023
- Study completion16 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain, AcuteStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- Contrad Swiss SA
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05886608
- Sponsor's protocol ID
- CTD-SW AI500 2021
- Status last verified
- May 2023
- First submitted
- 12 May 2023
- Last updated
- 2 Jun 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05886608
- Acronym / sponsor ID
- CTD-SW AI500 2021
- Conditions
- Pain, Acute, Pain, Chronic, Knee Injuries, Knee Osteoarthritis, Knee Arthritis, Knee Pain Swelling
- Keywords
- Knee, Pain, Hyaluronic Acid, Peptides, Non-invasive
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Contrad Swiss SAIndustry (pharma, biotech, devices)
- Study start
- 30 Aug 2022 (actual)
- Primary completion
- 16 Mar 2023 (actual)
- Study completion
- 16 Mar 2023 (actual)
- First posted
- 2 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| AI500 single-dose gel | Other | Device: AI 500™ SINGLE-DOSE GELInterventional study on AI500 1.5 mL will be topically administered twice: the first at T0 and the second 24h from T0 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (15 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AI 500™ SINGLE-DOSE GELAI500™ 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. | Device | AI500 single-dose gel |
Primary outcome
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.
3 secondary outcomes
Clinical performance of AI500™ SINGLE DOSE GEL in improving knee function after 48 hours
Time frame: 2 days
Clinical performance of AI500™ SINGLE DOSE GEL in alleviating pain after 24h and 48h of treatment.
Time frame: 2 days
Safety and Tolerability of AI500™ SINGLE DOSE GEL
Time frame: 1 week
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jun 2023.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing AI 500™ SINGLE-DOSE GEL in people with Pain, Acute and Pain, Chronic, run by Contrad Swiss SA at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical performance of AI500™ SINGLE DOSE GEL in improving knee function after 1 week (time frame: 1 Week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jun 2023.