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Autologous Conditioned Plasma (ACP) for Patients With Plantar Fasciitis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01614223
Recruitment Status : Unknown
Verified April 2014 by Dianne Bryant, University of Western Ontario, Canada.
Recruitment status was:  Recruiting
First Posted : June 7, 2012
Last Update Posted : April 25, 2014
Arthrex, Inc.
Information provided by (Responsible Party):
Dianne Bryant, 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

Condition or disease Intervention/treatment Phase
Chronic Plantar Fasciitis Procedure: ACP Drug: Corticosteroid (celestone) injection Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 140 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized Double-Blind Clinical Trial to Investigate the Use of Autologous Conditioned Plasma (ACP) for Patients With Plantar Fasciitis
Study Start Date : September 2010
Estimated Primary Completion Date : September 2015
Estimated Study Completion Date : September 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Foot Health

Arm Intervention/treatment
Active Comparator: ACP treatment Procedure: ACP
Within two weeks of the initial visit, the RN, will retrieve a 10-12 mL blood sample from all patients. After the sample is retrieved, the patient will be asked to lie prone on the plinth to assist with blinding. The blood sample will be retained in the Arthrex ABS-10010S Double Syringe with Syringe Cap and then separated using a soft spin centrifuge for 5 min at 1500 rpm/rcf. Three to four mL of platelet rich plasma will be pulled into a smaller syringe that is wrapped in opaque tape to conceal the contents of the syringe. The ACP is injected into the torn region of the tendon.

Active Comparator: Corticosteroid treatment Drug: Corticosteroid (celestone) injection
Preparation of the blood sample is identical for patients in this group except that the blood sample will ultimately be discarded instead of injected. The syringe is blinded with opaque tape making it identical to the ACP group syringe and injected into the torn area of the tendon.

Primary Outcome Measures :
  1. American Orthopaedic Foot and Ankle Midfoot Scale (AOFAS) [ Time Frame: 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 :
  1. Plantar Fasciitis Pain/Disability Scale (PFPD [ Time Frame: 6 weeks, 3, 6 and 12 months ]
  2. SF-12 [ Time Frame: 6 weeks, 3,6,12 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01614223

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Contact: Dianne Bryant, PhD 519-661-2111 ext 80349

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Canada, Ontario
Fowler Kennedy Sport Medicine Clinic Recruiting
London, Ontario, Canada, N6A 3K7
Principal Investigator: Kevin Willits, Md, FRCSC         
Sub-Investigator: Dianne Bryant, PhD         
Sponsors and Collaborators
University of Western Ontario, Canada
Arthrex, Inc.
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Study Director: Dianne Bryant, PhD University of Western Ontario, Canada

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Responsible Party: Dianne Bryant, Associate Professor, University of Western Ontario, Canada Identifier: NCT01614223     History of Changes
Other Study ID Numbers: FKSCM 2010 -1
First Posted: June 7, 2012    Key Record Dates
Last Update Posted: April 25, 2014
Last Verified: April 2014

Keywords provided by Dianne Bryant, University of Western Ontario, Canada:
Plantar fasciitis
Autologous Conditioned Plasma

Additional relevant MeSH terms:
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Fasciitis, Plantar
Musculoskeletal Diseases
Foot Diseases
Anti-Inflammatory Agents
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents