Clinical trial NCT01614223: Autologous Conditioned Plasma (ACP) for Patients With Plantar Fasciitis
Official title: A Randomized Double-Blind Clinical Trial to Investigate the Use of Autologous Conditioned Plasma (ACP) for Patients With Plantar Fasciitis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Chronic Plantar Fasciitis
Keywords: Plantar fasciitis
Autologous Conditioned Plasma
Lead sponsor: University of Western Ontario, Canada
Sponsor class: OTHER
Collaborators: name: Arthrex, Inc.
First posted: 2012-06-07
Enrollment: 140
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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.

Primary outcomes:
measure: American Orthopaedic Foot and Ankle Midfoot Scale (AOFAS)
timeFrame: 6 weeks, 3, 6 and 12 months
Secondary outcomes:
measure: Plantar Fasciitis Pain/Disability Scale (PFPD
timeFrame: 6 weeks, 3, 6 and 12 months
measure: SF-12
timeFrame: 6 weeks, 3,6,12 months
Other outcomes:
Locations:
city: London
country: Canada
facility: Fowler Kennedy Sport Medicine Clinic
state: Ontario
Study officials:
affiliation: The University of Western Ontario
name: Dianne Bryant, PhD
role: STUDY_DIRECTOR
References: