NCT07299851招募中不适用
Randomized, Double-blind, Placebo-controlled Study With 12 Weeks Oral Supplementation With a Formulation Based on Cetylated Fatty Acids to Support the Early Stage of Long Lower Limb Bone Healing After Fracture Stabilization
Pharmanutra S.p.a.9 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2025年10月1日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 100
- 试验地点
- 9
- 主要终点
- Radiographic Assessment of Callus Formation using the modified Radiographic Union Score for Tibia (mRUST).
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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, recurring syncope)
- •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.
结局指标
主要结局
Radiographic Assessment of Callus Formation using the modified Radiographic Union Score for Tibia (mRUST).
时间窗: 6 weeks after fracture stabilization
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).
次要结局
- Pain Assessment at Fracture Site using the Visual Analog Scale (VAS)(4 weeks after fracture stabilization)
- Ultrasonographic Assessment of Callus Formation(4 weeks after fracture stabilization)
- Radiographic Assessment of Callus Formation (modified Radiographic Union Score for Tibia - mRUST)(12 weeks after fracture stabilization)
- Pain Assessment at Fracture Site (Visual Analog Scale - VAS)(12 weeks after fracture stabilization)
- Incidence of Complications(4 weeks and 12 weeks after fracture stabilization)
- Minimal Clinically Important Improvement (MCII)(4 weeks and 12 weeks after fracture stabilization)
- Participant Acceptable Symptom State (PASS)(4 weeks and 12 weeks after fracture stabilization)
- Participant Global Assessment (PGA)(4 weeks and 12 weeks after fracture stabilization)
- Lower Extremity Functional Scale (LEFS)(4 weeks and 12 weeks after fracture stabilization)
- Quality of Life using the Short Form-36 (SF-36) questionnaire.(4 weeks and 12 weeks after fracture stabilization)
- Painkiller and NSAID Consumption(4 weeks and 12 weeks after fracture stabilization)
- Incidence of Adverse Events (AE) and Serious Adverse Events (SAE)(4 weeks and 12 weeks after fracture stabilization)
- Participant Compliance Rate(4 weeks and 12 weeks after fracture stabilization)
- Participant Satisfaction(4 weeks and 12 weeks after fracture stabilization)
研究者
研究点 (9)
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