CETI-ANKLE: Cetilar®️ in Patients With Ankle Injury or Chronic Trauma to the Ankle

Study Overview
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Brief Summary
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The purpose of this study is to assess the safety, tolerability and efficacy of Cetilar®

Detailed Description
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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).

Official Title
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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

Conditions
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Ankle Injury or Chronic Trauma to the Ankle

Intervention / Treatment
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* Device: Cetilar® (topical cream)
* Device: Cetilar Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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) 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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment group (Cetilar®)<br>Participants received Cetilar® topical cream twice daily for 30 days. An average amount of 5 g per day | Device: Cetilar® (topical cream)<br>* Topical cream twice daily for 30 days. An average amount of 5 g per day.<br>|
| Placebo Comparator: Control group (Placebo)<br>Participants received Cetilar Placebo topical cream twice daily for 30 days. An average amount of 5 g per day | Device: Cetilar Placebo<br>* Cetilar placebo cream matching to Cetilar®. Topical cream twice daily for 30 days. An average amount of 5 g per day<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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: 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. | 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). | 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. | From Baseline to Day 30 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The number and % of patients with treatment-emergent adverse events | Incidence and severity of adverse events (AEs) that occurred during the treatment. | From Baseline to Day 30 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Ankle injury, Chronic trauma, Ankle trauma, Cetilar