Clinical trial NCT06137820: CETI-ANKLE: Cetilar®️ in Patients With Ankle Injury or Chronic Trauma to the Ankle
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
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Ankle Injury or Chronic Trauma to the Ankle
Keywords: Ankle injury
Chronic trauma
Ankle trauma
Cetilar
Lead sponsor: Pharmanutra S.p.a.
Sponsor class: INDUSTRY
Collaborators: name: NEA Clinical S.r.l.
First posted: 2023-11-18
Enrollment: 80
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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).

Eligibility criteria: 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

Primary outcomes:
measure: Change From Baseline in FAAM (Foot and Ankle Ability and Measure) total score questionnaire on day 30
timeFrame: From Baseline to Day 30
measure: Change From Baseline in Pain on the Visual Analogue Scale (VAS scale) on day 30
timeFrame: From Baseline to Day 30
measure: Change From Baseline in QoL (Quality of Life) total score questionnaire on day 30
timeFrame: From Baseline to Day 30
Secondary outcomes:
measure: The number and % of patients with treatment-emergent adverse events
timeFrame: From Baseline to Day 30
Other outcomes:
Locations:
city: Tbilisi
country: Georgia
facility: LLC "Altra Vita"
city: Tbilisi
country: Georgia
facility: JSC "Evex Hospitals" (Caraps Medline)
city: Viterbo
country: Italy
facility: Azienda Sanitaria Locale Viterbo | ASL Viterbo, Dipartimento di Ortopedia (Centro Coordinatore)
Study officials:
affiliation: Pharmanutra S.p.a.
name: Maria Sole Rossato
role: STUDY_DIRECTOR
References: