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New treatment option for Fracture Femur
Official title Oral Supplementation With a Formulation Based on Cetylated Fatty Acids for Post-fracture Long Bone Healing
ClinicalTrials.gov ID: NCT07299851
What this study is testing
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 85
You may be able to join if
- 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...
- Presence of diaphyseal fracture of lower limb (femur or tibia, Subtrochanteric fracture are also allowed)
- Presence intramedullary nail
- Weight bearing as tolerated after surgery
You likely can't join if
- Treatment with vitamin D for medical purpose (Non-union, osteoporosis…)
- BMI \> 30
- Open fracture
- Intra articular fracture
- Metaphyseal fracture
- Polytrauma patient (injury severity score: ISS \>= 16)
See the full eligibility criteria
- 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
- Weight bearing as tolerated after surgery
- Having signed an informed consent, understand study procedures and ability to follow them
- Agreed to stop vitamin D intake for participants who take prophylactic Vitamin D
- Treatment with vitamin D for medical purpose (Non-union, osteoporosis…)
- BMI \> 30
- Open fracture
- Intra articular fracture
- Metaphyseal fracture
- Polytrauma patient (injury severity score: ISS \>= 16)
- More than one lower limb long bone fracture
- Bridging plate
- Fracture treated conservatively with plaster
- Presence of active infection (body temperature ≥ 38°C or other symptoms)
- Any sign of severe vascular compromise across the fracture site (such as compartment syndrome, presence of serious vascular damage, etc.)
- Pathological fracture or diseases with a risk of recurrent falling (e.g. Parkinson's disease/syndrome, Hemiplegia after stroke, symptomatic stenosis of the spinal canal, polyneuropathy, epilepsy, recurring vertigo...
- Participants with known bone disease which would negatively impact on the bone healing process
- Participants currently being treated with radiation, chemotherapy, immunosuppression, or steroid therapy
- Diabetic participants
- Daily smoker participants (cigarette or vaping containing nicotine)
- Participants under cortisone intake
- Participants under rheumatic medications intake
- Allergy or adverse effect of food supplement composition
- Unwilling or unable to take study medication
- Chronic drug or alcohol abuse
- Pregnant or breastfeeding at the time of enrolment
- Any other investigational treatment or food supplement within 3 months.
The study team makes the final eligibility decision.
Where it's taking place
- Deurne, Antwerp, Belgium
- Herentals, Antwerp, Belgium
- Brussels, Brussels Capital, Belgium
- Ghent, Flanders, Belgium
- Genk, Limburg, Belgium
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 85 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Deurne, Antwerp, Belgium; Herentals, Antwerp, Belgium; Brussels, Brussels Capital, Belgium; Ghent, Flanders, Belgium; Genk, Limburg, Belgium. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.