Autologous Conditioned Plasma (ACP) for Patients With Plantar Fasciitis
- Conditions
- Chronic Plantar Fasciitis
- Interventions
- Procedure: ACPDrug: Corticosteroid (celestone) injection
- Registration Number
- NCT01614223
- Lead Sponsor
- University of Western Ontario, Canada
- Brief Summary
Plantar fasciitis presents clinically as pain in the inner heal, which is the result of degeneration of the plantar fascia, an arch supporting ligament of the foot. It manifests predominantly in those subjected to sustained weight bearing or repetitive pounding activities. Plantar fasciitis is the most common cause of inferior foot pain. Although most cases resolving within 6 months, traditional treatment regiments such as orthotics and physiotherapy are occasionally unsuccessful in treating this limitation leading to chronic symptoms (Neufeld \& Cerrato, 2008; Rompe, 2009; Roxas, 2005).
Platelets are central players in clotting, inflammation and the wound healing response. Research has shown the potential of platelet rich plasma to accelerate wound healing in a variety of conditions including maxillo-fascial and plastic surgery, chronic wound healing and orthopaedics. Autologous Conditioned Plasma (ACP) is a novel treatment that may accelerate the healing of injured tissue. Treatment with ACP involves taking a blood sample from the patient, isolating the platelets and injecting them back into that patient at the injury site
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 140
- Painful inner heel pain for longer than three months
- at least six weeks since last corticosteroid injection
- four weeks since the last anaesthetic injection, iontophoresis, ultrasound and electromyostimulation
- one week since the last NSAIDs taken
- two days since the last analgesic, heat, ice, message, stretching, or modification of night splints and orthosis.
- scores greater or equal to 5 on the VAS PFPD scale
- scores greater or equal 30 on the AOFAS scale
- scores of greater or equal to 5 on the VAS PFPD scale and 30 on the AOFAS scale
- tendon rupture
- neurological or vascular insufficiencies in the painful heel
- bilateral heel pain
- Paget's disease or calcaneal fat pad atrophy
- osteomyelitis, fracture of the calcaneus, ankle inflammation
- recent infection in the treatment area, history of rheumatic diseases
- collagenosis or metabolic disorders
- immunosuppressive therapy or coagulation disturbance and/or therapy, long-term treatment with corticosteroids
- previous heel surgery
- malignant disease, diabetes mellitus, severe cardiac or respiratory disease, significant abnormalities in hepatic function
- participation in another clinical study at the same time.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description ACP treatment ACP - Corticosteroid treatment Corticosteroid (celestone) injection -
- Primary Outcome Measures
Name Time Method American Orthopaedic Foot and Ankle Midfoot Scale (AOFAS) 6 weeks, 3, 6 and 12 months Inlcudes subjective and objective assessments and has demonstrated test retest reliability, validity, sensitivity to change and responsiveness for conditions of the foot and ankle. A minimally important change is considered to be at least a 5 point change with an effect size of 0.59.
- Secondary Outcome Measures
Name Time Method Plantar Fasciitis Pain/Disability Scale (PFPD 6 weeks, 3, 6 and 12 months SF-12 6 weeks, 3,6,12 months
Trial Locations
- Locations (1)
Fowler Kennedy Sport Medicine Clinic
🇨🇦London, Ontario, Canada