Status:
UNKNOWN
CETI-ANKLE: Cetilar®️ in Patients With Ankle Injury or Chronic Trauma to the Ankle
Lead Sponsor:
Pharmanutra S.p.a.
Collaborating Sponsors:
NEA Clinical S.r.l.
Conditions:
Ankle Injury or Chronic Trauma to the Ankle
Eligibility:
All Genders
20-80 years
Phase:
NA
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 incl...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 18 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 31 2023
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT06137820
Start Date
November 18 2022
End Date
December 31 2023
Last Update
November 18 2023
Active Locations (3)
Enter a location and click search to find clinical trials sorted by distance.
1
LLC "Altra Vita"
Tbilisi, Georgia, 0160
2
JSC "Evex Hospitals" (Caraps Medline)
Tbilisi, Georgia
3
Azienda Sanitaria Locale Viterbo | ASL Viterbo, Dipartimento di Ortopedia (Centro Coordinatore)
Viterbo, Italy, 01100