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

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®

Study Overview

• Status: Active, not recruiting
• Conditions: Ankle Injury or Chronic Trauma to the Ankle
• Intervention / Treatment: Device: Cetilar® (topical cream); Device: Cetilar Placebo

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 Type: Interventional
• Enrollment (Actual): 80
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Georgia
  • Tbilisi, Georgia, 0160
    • LLC "Altra Vita"
  • Tbilisi, Georgia
    • JSC "Evex Hospitals" (Caraps Medline)
• Italy
  • Viterbo, Italy, 01100
    • Azienda Sanitaria Locale Viterbo | ASL Viterbo, Dipartimento di Ortopedia (Centro Coordinatore)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Signing the Patient Information Sheet and Informed Consent Form
2. Patients with reduced ankle mobility caused by injury or chronic trauma to the ankle
3. Men or women aged ≥20 and ≤80 years
4. Patients who mark the pain 4 cm on a VAS
5. Patients who are willing or able to follow doctor's instructions
6. Patients not participating in other clinical trials within 30 days before the screening
7. Patients who have received sufficient explanation for this clinical trial and agreed to participate

Exclusion Criteria:

1. Patients who received intraarticular injection treatment into the painful area within 3 months prior to the first visit
2. Ankle surgery in the previous six months
3. Topical NSAIDs application during the treatment period
4. BMI > 32
5. Systemic inflammatory diseases (e.g. fibromyalgia, etc.)
6. Progressive serious medical conditions (such as cancer, AIDS or end-stage renal disease)
7. Patients with major infections in the observation period
8. 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)
9. Liver dysfunction (serum alanine or aspartate transaminase concentrations more than 1.5 times the upper limit of normal range)
10. Patients with serious heart-related diseases such as cardiac arrest, a history of cerebral infarction, or ischemic heart disease
11. Patients who received systemic steroid treatment within 1 month prior to their first visit
12. Diabetic foot
13. Pregnant or lactating women

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Pharmanutra S.p.a.
• Collaborators: NEA Clinical S.r.l.
• Investigators: Study Director: Maria Sole Rossato, Pharmanutra S.p.a.

Study record dates

Study Major Dates

• Study Start (Actual): November 18, 2022
• Primary Completion (Actual): August 19, 2023
• Study Completion (Estimated): December 31, 2023

Study Registration Dates

• First Submitted: October 18, 2023
• First Submitted That Met QC Criteria: November 14, 2023
• First Posted (Estimated): November 17, 2023

Study Record Updates

• Last Update Posted (Estimated): November 17, 2023
• Last Update Submitted That Met QC Criteria: November 14, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Keywords: Ankle injury; Chronic trauma; Ankle trauma; Cetilar
• Additional Relevant MeSH Terms: Leg Injuries; Wounds and Injuries; Ankle Injuries
• Other Study ID Numbers: CET 01/22

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No