Oral Supplementation With a Formulation Based on Cetylated Fatty Acids for Post-fracture Long Bone Healing
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-85
SponsorPharmanutra S.p.a.
About this trial
This clinical study aims to evaluate the potential benefits of a formulation based on Cetylated Fatty Acids in improving fracture healing of long bones in the lower limbs. The investigational product is administered orally over a 12-week period. Study procedures are limited to standard imaging techniques (radiography and echography), blood sampling, and completion of validated quality of life questionnaires.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Between 18 and 85 years old
Presence of simple closed unifocal fracture (transverse, oblique, spiral, butterfly-shaped) in a long bone which need a standard of care surgical stabilization
Presence of diaphyseal fracture of lower limb (femur or tibia, Subtrochanteric fracture are also allowed)
Presence intramedullary nail
Disqualifiers
Treatment with vitamin D for medical purpose (Non-union, osteoporosis…)
BMI > 30
Open fracture
Intra articular fracture
Trial design
Design model
Parallel
Treatments tested in this trial
CFA-based food supplement
Dietary supplementoral gel containing cetilated fatty acids
Placebo
Other interventionoral gel coloured and flavoured as the IP
Treatment groups
100 Participants
are divided into 2 treatment groupsGroup A: CFA-based supplement groupExperimental treatment 1 intervention
Group B: Placebo groupPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Radiographic Assessment of Callus Formation using the modified Radiographic Union Score for Tibia (mRUST).
Comparison between groups of radiographic assessment of the callus formation using mRUST 6 weeks after fracture stabilisation. The mRUST scale ranges from 4 to 16 points, where higher scores indicate better fracture healing (greater callus formation and union).
Time frame
6 weeks after fracture stabilizationSecondary outcomes
1
Pain Assessment at Fracture Site using the Visual Analog Scale (VAS)
Change from baseline in pain perception in clinical assessment using the VAS 4 weeks after fracture stabilization. The VAS ranges from 0 to 10, where 0 indicates no pain and 10 indicates the worst imaginable pain. Higher scores represent worse outcomes (greater pain intensity).
Time frame
4 weeks after fracture stabilization2
Ultrasonographic Assessment of Callus Formation
Change from placebo group in ultrasonographic evaluation of hypervascularisation and callus formation. Measurement of callus size (length and thickness) in millimeters using B-mode ultrasound imaging at the fracture site. The assessment is performed 4 weeks after fracture stabilization. Larger callus size indicates better bone healing.
Time frame
4 weeks after fracture stabilization3
Radiographic Assessment of Callus Formation (modified Radiographic Union Score for Tibia - mRUST)
Radiographic union will be evaluated using the modified Radiographic Union Score for Tibia (mRUST), which rates healing on a 4-16 scale, with higher scores indicating better callus formation and more advanced fracture healing. Comparison between groups at Week 12.
Time frame
12 weeks after fracture stabilization4
Pain Assessment at Fracture Site (Visual Analog Scale - VAS)
Pain at the fracture site will be assessed using the Visual Analog Scale (VAS), a 0-100 mm scale, where higher scores indicate worse pain. The endpoint evaluates the change from baseline to Week 12.
Time frame
12 weeks after fracture stabilizationSponsors and contacts
Click on the lead sponsor to view all of their trials.
Pharmanutra S.p.a.
Lead sponsor
Artialis
Collaborator
Source ClinicalTrials.gov