An interventional study of Cetilar® (topical cream) and Cetilar Placebo in Ankle Injury or Chronic Trauma to the Ankle, sponsored by Pharmanutra S.p.a.. Active, not recruiting at 3 sites in 2 countries. Open to participants aged 20 Years to 80 Years. Per ClinicalTrials.gov, last updated 2023-11-18.
Sponsored by Pharmanutra S.p.a. · Not applicable, Interventional, and Treatment
The purpose of this study is to assess the safety, tolerability and efficacy of Cetilar®
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).
5,056 studies on the registry are indexed under Wounds and Injuries; 861 are open to participants now.
This study's enrollment of 80 is above the median of 52 across 3,239 interventional studies indexed under Wounds and Injuries.
Browse Wounds and Injuries studies →Pharmanutra S.p.a. is the lead sponsor of 7 studies on the registry; 3 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Participants received Cetilar® topical cream twice daily for 30 days. An average amount of 5 g per day
Device: Cetilar® (topical cream)
Participants received Cetilar Placebo topical cream twice daily for 30 days. An average amount of 5 g per day
Device: Cetilar Placebo
Topical cream twice daily for 30 days. An average amount of 5 g per day.
Cetilar placebo cream matching to Cetilar®. Topical cream twice daily for 30 days. An average amount of 5 g per day
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.
Time frame: 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).
Time frame: 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.
Time frame: From Baseline to Day 30
The number and % of patients with treatment-emergent adverse events
Incidence and severity of adverse events (AEs) that occurred during the treatment.
Time frame: From Baseline to Day 30
Plan to share: No
No publications or documents are linked to this record.
This study is active, not recruiting, as verified in Nov 2023. You cannot join it, but the record below documents what was studied.
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Pharmanutra S.p.a.