Autologous Conditioned Plasma (ACP) for Patients With Plantar Fasciitis
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|ClinicalTrials.gov 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
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|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||140 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Outcomes Assessor)|
|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|
|Active Comparator: ACP treatment||
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.
- 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.
- Plantar Fasciitis Pain/Disability Scale (PFPD [ Time Frame: 6 weeks, 3, 6 and 12 months ]
- SF-12 [ Time Frame: 6 weeks, 3,6,12 months ]
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 ClinicalTrials.gov identifier (NCT number): NCT01614223
|Contact: Dianne Bryant, PhD||519-661-2111 ext firstname.lastname@example.org|
|Fowler Kennedy Sport Medicine Clinic||Recruiting|
|London, Ontario, Canada, N6A 3K7|
|Principal Investigator: Kevin Willits, Md, FRCSC|
|Sub-Investigator: Dianne Bryant, PhD|
|Study Director:||Dianne Bryant, PhD||University of Western Ontario, Canada|