Ankle Injury or Chronic Trauma to the AnkleNCT06137820
CETI-ANKLE: Cetilar®️ in Patients With Ankle Injury or Chronic Trauma to the Ankle
A study testing Cetilar® (topical cream) in people with Ankle Injury or Chronic Trauma to the Ankle, run by Pharmanutra S.p.a. at 3 sites in 2 countries.
Trial summary
The purpose of this study is to assess the safety, tolerability and efficacy of Cetilar® Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Ankle Injury or Chronic Trauma to the Ankle
- What is being tested?
- Cetilar® (topical cream)
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 3 sitesin 2 countries
- Study dates
- 18 Nov 2022to 31 Dec 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 20 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Signing the Patient Information Sheet and Informed Consent Form
- Patients with reduced ankle mobility caused by injury or chronic trauma to the ankle
- Men or women aged ≥20 and ≤80 years
- Patients who mark the pain 4 cm on a VAS
- Patients who are willing or able to follow doctor's instructions
- Patients not participating in other clinical trials within 30 days before the screening
- Patients who have received sufficient explanation for this clinical trial and agreed to participate
Who cannot join
- Patients who received intraarticular injection treatment into the painful area within 3 months prior to the first visit
- Ankle surgery in the previous six months
- Topical NSAIDs application during the treatment period
- BMI > 32
- Systemic inflammatory diseases (e.g. fibromyalgia, etc.)
- Progressive serious medical conditions (such as cancer, AIDS or end-stage renal disease)
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- Patients with major infections in the observation period
- Renal diseases (serum creatinine concentration more than 1.2 times the upper limit of the normal range according to the central laboratory definition reference values)
- Liver dysfunction (serum alanine or aspartate transaminase concentrations more than 1.5 times the upper limit of normal range)
- Patients with serious heart-related diseases such as cardiac arrest, a history of cerebral infarction, or ischemic heart disease
- Patients who received systemic steroid treatment within 1 month prior to their first visit
- Diabetic foot
- Pregnant or lactating women
Trial locations and contacts
3 sites in 2 countries.
3 sites in 2 countries
Georgia2 sites
LLC "Altra Vita"
Tbilisi, 0160
JSC "Evex Hospitals" (Caraps Medline)
Tbilisi
Italy1 site
Azienda Sanitaria Locale Viterbo | ASL Viterbo, Dipartimento di Ortopedia (Centro Coordinatore)
Viterbo, 01100
About this study
Official title: Randomized Placebo-controlled Multi-center Study of Efficacy and Safety of a CFA-based Topical Cream Cetilar®️ in Patients With Ankle Injury or Chronic Trauma to the Ankle
The purpose of this study is to assess the safety, tolerability and efficacy of Cetilar®
Read the detailed description
After being informed about the study, all patients giving written informed consent will undergo no more than a 1-week screening period to determine eligibility for study entry. Patients that meet inclusion criteria and do not have exclusion criteria will be randomized in a double-blind manner (participant and investigator) in a 1:1 ratio to Cetilar® cream (about 5 g, twice per day) or placebo cream (about 5 g, twice per day).
- Being tested
- Cetilar® (topical cream), Cetilar Placebo
- Keywords
- Ankle injury, Chronic trauma, Ankle trauma, Cetilar
- Medical subject headings
- Ankle Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cetilar® (topical cream)Device
Topical cream twice daily for 30 days. An average amount of 5 g per day.
Cetilar PlaceboDevice
Cetilar placebo cream matching to Cetilar®. Topical cream twice daily for 30 days. An average amount of 5 g per day
| Study group | Role | What they receive |
|---|---|---|
| Treatment group (Cetilar®) | Experimental | Participants received Cetilar® topical cream twice daily for 30 days. An average amount of 5 g per day Receives: Device: Cetilar® (topical cream) |
| Control group (Placebo) | Placebo comparator | Participants received Cetilar Placebo topical cream twice daily for 30 days. An average amount of 5 g per day Receives: Device: Cetilar Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline in FAAM (Foot and Ankle Ability and Measure) total score questionnaire on day 30
FAAM is a validated questionnaire assessing mobility and functionality on Day 30. Change = (Day 30 - Baseline Score).
This instrument includes 2 subscales:
- Activities of Daily Living (ADLs) subscale of 21 items
- Sports subscale of 7 items. For each subscale patients were asked to answer each question with a single response that most clearly described their condition within the past week.
Answers for both scales are based on a Likert scale (4-0) of:
- "no difficulty" 3) "slight difficulty" 2) "moderate difficulty"
- "extreme difficulty" 0) "unable to do" If an activity in question was limited by something other than their ankle, the patient was asked to record N/A To calculate the score for either subscale, the total number of points are added, divided by the total number of possible and then multiplied by 100.
Therefore, a higher score reflects a higher level of physical function.
Measured: From Baseline to Day 30
Change From Baseline in Pain on the Visual Analogue Scale (VAS scale) on day 30
Visual analogue scale (VAS) is a validated questionnaire assessing pain intensity on Day 30. Possible scores range from 0 cm (no pain) to 10 cm (Pain as bad as it could be). Change = (Day 30 - Baseline Score).
Measured: From Baseline to Day 30
Change From Baseline in QoL (Quality of Life) total score questionnaire on day 30
QoL is a validated questionnaire assessing taps eight health concepts: physical functioning, bodily pain, role limitations due to physical health problems, role limitations due to personal or emotional problems, general mental health, social functioning, energy/fatigue, and general health perceptions on Day 30. Change = (Day 30 - Baseline Score). Scale scores represent the average for all items in the scale that the patients answered.
Measured: From Baseline to Day 30
Secondary outcomes (1)
The number and % of patients with treatment-emergent adverse events
Incidence and severity of adverse events (AEs) that occurred during the treatment.
Measured: From Baseline to Day 30
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2023
- Study start18 Nov 2022
- Primary completion19 Aug 2023
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ankle Injury or Chronic Trauma to the AnkleStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pharmanutra S.p.a.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- NEA Clinical S.r.l.
- Responsible party
- Sponsor
- Investigators
- Maria Sole Rossato, Study director, Pharmanutra S.p.a.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06137820
- Sponsor's protocol ID
- CET 01/22
- Status last verified
- Nov 2023
- First submitted
- 18 Oct 2023
- Last updated
- 18 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Placebo-controlled Multi-center Study of Efficacy and Safety of a CFA-based Topical Cream Cetilar®️ in Patients With Ankle Injury or Chronic Trauma to the Ankle
- ClinicalTrials.gov ID
- NCT06137820
- Acronym / sponsor ID
- CET 01/22
- Keywords
- Ankle injury, Chronic trauma, Ankle trauma, Cetilar
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Pharmanutra S.p.a.Industry (pharma, biotech, devices)
- Collaborators
- NEA Clinical S.r.l.
- Study start
- 18 Nov 2022 (actual)
- Primary completion
- 19 Aug 2023 (actual)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 18 Nov 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.
The purpose of this study is to assess the safety, tolerability and efficacy of Cetilar®
Detailed description
After being informed about the study, all patients giving written informed consent will undergo no more than a 1-week screening period to determine eligibility for study entry. Patients that meet inclusion criteria and do not have exclusion criteria will be randomized in a double-blind manner (participant and investigator) in a 1:1 ratio to Cetilar® cream (about 5 g, twice per day) or placebo cream (about 5 g, twice per day).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment group (Cetilar®) | Experimental | Device: Cetilar® (topical cream)Participants received Cetilar® topical cream twice daily for 30 days. An average amount of 5 g per day |
| Control group (Placebo) | Placebo comparator | Device: Cetilar PlaceboParticipants received Cetilar Placebo topical cream twice daily for 30 days. An average amount of 5 g per day |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Signing the Patient Information Sheet and Informed Consent Form
- Patients with reduced ankle mobility caused by injury or chronic trauma to the ankle
- Men or women aged ≥20 and ≤80 years
- Patients who mark the pain 4 cm on a VAS
- Patients who are willing or able to follow doctor's instructions
Key exclusion criteria (13 listed)
- Patients who received intraarticular injection treatment into the painful area within 3 months prior to the first visit
- Ankle surgery in the previous six months
- Topical NSAIDs application during the treatment period
- BMI > 32
- Systemic inflammatory diseases (e.g. fibromyalgia, etc.)
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 |
|---|---|---|
| Cetilar® (topical cream)Topical cream twice daily for 30 days. An average amount of 5 g per day. | Device | Treatment group (Cetilar®) |
| Cetilar PlaceboCetilar placebo cream matching to Cetilar®. Topical cream twice daily for 30 days. An average amount of 5 g per day | Device | Control group (Placebo) |
Primary outcome
Change From Baseline in FAAM (Foot and Ankle Ability and Measure) total score questionnaire on day 30
Time frame: From Baseline to Day 30
FAAM is a validated questionnaire assessing mobility and functionality on Day 30. Change = (Day 30 - Baseline Score). This instrument includes 2 subscales: 1. Activities of Daily Living (ADLs) subscale of 21 items 2. Sports subscale of 7 items. For each subscale patients were asked to answer each question with a single response that most clearly described their condition within the past week. Answers for both scales are based on a Likert scale (4-0) of: 4) "no difficulty" 3) "slight difficulty" 2) "moderate difficulty" 1) "extreme difficulty" 0) "unable to do" If an activity in question was limited by something other than their ankle, the patient was asked to record N/A To calculate the score for either subscale, the total number of points are added, divided by the total number of possible and then multiplied by 100. Therefore, a higher score reflects a higher level of physical function.
Change From Baseline in Pain on the Visual Analogue Scale (VAS scale) on day 30
Time frame: From Baseline to Day 30
Visual analogue scale (VAS) is a validated questionnaire assessing pain intensity on Day 30. Possible scores range from 0 cm (no pain) to 10 cm (Pain as bad as it could be). Change = (Day 30 - Baseline Score).
Change From Baseline in QoL (Quality of Life) total score questionnaire on day 30
Time frame: From Baseline to Day 30
QoL is a validated questionnaire assessing taps eight health concepts: physical functioning, bodily pain, role limitations due to physical health problems, role limitations due to personal or emotional problems, general mental health, social functioning, energy/fatigue, and general health perceptions on Day 30. Change = (Day 30 - Baseline Score). Scale scores represent the average for all items in the scale that the patients answered.
1 secondary outcome
The number and % of patients with treatment-emergent adverse events
Time frame: From Baseline to Day 30
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2023.
- Individual participant dataSharing planned: No
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.
Maria Sole Rossato study director
Pharmanutra S.p.a.
3 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cetilar® (topical cream) in people with Ankle Injury or Chronic Trauma to the Ankle, run by Pharmanutra S.p.a. at 3 sites in 2 countries.
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 7 inclusion and 13 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: status not confirmed, as of the sponsor's last update on 18 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Georgia, 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. Some participants in this study may receive a placebo. 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?
Results are not available in the source record.
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?
Change From Baseline in FAAM (Foot and Ankle Ability and Measure) total score questionnaire on day 30 (time frame: From Baseline to Day 30). The study lists 3 primary outcomes in all. 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 18 Nov 2023.