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

NCT06137820 | Unknown

• 1 other identifier: CET 01/22
• Study Type: interventional
• Target: 80
• Locations: 2 countries
• Sites: 3

Brief Summary

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

Conditions

Ankle Injury or Chronic Trauma to the Ankle

Keywords

Ankle injury; Chronic trauma; Ankle trauma; Cetilar

Outcome Measures

Primary Outcomes (3)

• 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: 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.

  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 Outcomes (1)

• The number and % of patients with treatment-emergent adverse events

  From Baseline to Day 30

Study Arms (2)

Treatment group (Cetilar®)

EXPERIMENTAL

Participants received Cetilar® topical cream twice daily for 30 days. An average amount of 5 g per day

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

Device: Cetilar Placebo

Interventions

Cetilar® (topical cream) DEVICE

Topical cream twice daily for 30 days. An average amount of 5 g per day.

Treatment group (Cetilar®)

Cetilar Placebo DEVICE

Cetilar placebo cream matching to Cetilar®. Topical cream twice daily for 30 days. An average amount of 5 g per day

Control group (Placebo)

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Pharmanutra S.p.a.: lead
• NEA Clinical S.r.l.: collaborator

Study Sites (3)

LLC "Altra Vita"

Tbilisi, 0160, Georgia

Location

JSC "Evex Hospitals" (Caraps Medline)

Tbilisi, Georgia

Location

Azienda Sanitaria Locale Viterbo | ASL Viterbo, Dipartimento di Ortopedia (Centro Coordinatore)

Viterbo, 01100, Italy

Location

MeSH Terms

Conditions

Ankle Injuries

Condition Hierarchy (Ancestors)

Leg Injuries; Wounds and Injuries

Study Officials

• Maria Sole Rossato

  Pharmanutra S.p.a.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 18, 2023
• First Posted: November 18, 2023
• Study Start: November 18, 2022
• Primary Completion: August 19, 2023
• Study Completion: December 31, 2023
• Last Updated: November 18, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

GE (2); IT (1)