Autologous Conditioned Plasma (ACP) for Patients With Plantar Fasciitis

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2014 by University of Western Ontario, Canada
Sponsor:
Collaborator:
Arthrex, Inc.
Information provided by (Responsible Party):
Dianne Bryant, University of Western Ontario, Canada
ClinicalTrials.gov Identifier:
NCT01614223
First received: June 4, 2012
Last updated: April 24, 2014
Last verified: April 2014
  Purpose

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 Intervention
Chronic Plantar Fasciitis
Procedure: ACP
Drug: Corticosteroid (celestone) injection

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:


Further study details as provided by University of Western Ontario, Canada:

Primary Outcome Measures:
  • American Orthopaedic Foot and Ankle Midfoot Scale (AOFAS) [ Time Frame: 6 weeks, 3, 6 and 12 months ] [ Designated as safety issue: No ]
    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:
  • Plantar Fasciitis Pain/Disability Scale (PFPD [ Time Frame: 6 weeks, 3, 6 and 12 months ] [ Designated as safety issue: No ]
  • SF-12 [ Time Frame: 6 weeks, 3,6,12 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 140
Study Start Date: September 2010
Estimated Study Completion Date: September 2015
Estimated Primary Completion Date: September 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01614223

Contacts
Contact: Dianne Bryant, PhD 519-661-2111 ext 80349 dianne.bryant@uwo.ca

Locations
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.
Investigators
Study Director: Dianne Bryant, PhD University of Western Ontario, Canada
  More Information

No publications provided

Responsible Party: Dianne Bryant, Associate Professor, University of Western Ontario, Canada
ClinicalTrials.gov Identifier: NCT01614223     History of Changes
Other Study ID Numbers: FKSCM 2010 -1
Study First Received: June 4, 2012
Last Updated: April 24, 2014
Health Authority: Canada: Health Ethics Research Board, The University of Western Ontario

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

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

ClinicalTrials.gov processed this record on August 28, 2014