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

NCT ID: NCT06137820

Last Updated: 2023-11-18

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-11-18
• Study Completion Date: 2023-12-31

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).

Conditions

Ankle Injury or Chronic Trauma to the Ankle

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Treatment group (Cetilar®)

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

Group Type: EXPERIMENTAL

Cetilar® (topical cream)

Intervention Type: DEVICE

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

Control group (Placebo)

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

Group Type: PLACEBO_COMPARATOR

Cetilar Placebo

Intervention Type: DEVICE

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

Interventions

Cetilar® (topical cream)

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

Intervention Type: DEVICE

Cetilar Placebo

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

Intervention Type: DEVICE

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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

NEA Clinical S.r.l.

UNKNOWN

Sponsor Role: collaborator

Pharmanutra S.p.a.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Maria Sole Rossato

Role: STUDY_DIRECTOR

Pharmanutra S.p.a.

Locations

LLC "Altra Vita"

Tbilisi, , Georgia

JSC "Evex Hospitals" (Caraps Medline)

Tbilisi, , Georgia

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

Viterbo, , Italy

Countries

Georgia; Italy

Other Identifiers

CET 01/22

Identifier Type: -

Identifier Source: org_study_id