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Autologous Conditioned Plasma (ACP) for Patients With Plantar Fasciitis

Primary Purpose

Chronic Plantar Fasciitis

Status
Unknown status
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
ACP
Corticosteroid (celestone) injection
Sponsored by
University of Western Ontario, Canada
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Plantar Fasciitis focused on measuring Plantar fasciitis, Autologous Conditioned Plasma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Fowler Kennedy Sport Medicine ClinicRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

ACP treatment

Corticosteroid treatment

Arm Description

Outcomes

Primary Outcome Measures

American Orthopaedic Foot and Ankle Midfoot Scale (AOFAS)
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
SF-12

Full Information

First Posted
June 4, 2012
Last Updated
April 24, 2014
Sponsor
University of Western Ontario, Canada
Collaborators
Arthrex, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT01614223
Brief Title
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

2. Study Status

Record Verification Date
April 2014
Overall Recruitment Status
Unknown status
Study Start Date
September 2010 (undefined)
Primary Completion Date
September 2015 (Anticipated)
Study Completion Date
September 2015 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Western Ontario, Canada
Collaborators
Arthrex, Inc.

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Plantar Fasciitis
Keywords
Plantar fasciitis, Autologous Conditioned Plasma

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
140 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
ACP treatment
Arm Type
Active Comparator
Arm Title
Corticosteroid treatment
Arm Type
Active Comparator
Intervention Type
Procedure
Intervention Name(s)
ACP
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Corticosteroid (celestone) injection
Intervention Description
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 Measure Information:
Title
American Orthopaedic Foot and Ankle Midfoot Scale (AOFAS)
Description
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.
Time Frame
6 weeks, 3, 6 and 12 months
Secondary Outcome Measure Information:
Title
Plantar Fasciitis Pain/Disability Scale (PFPD
Time Frame
6 weeks, 3, 6 and 12 months
Title
SF-12
Time Frame
6 weeks, 3,6,12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Dianne Bryant, PhD
Phone
519-661-2111
Ext
80349
Email
dianne.bryant@uwo.ca
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dianne Bryant, PhD
Organizational Affiliation
The University of Western Ontario
Official's Role
Study Director
Facility Information:
Facility Name
Fowler Kennedy Sport Medicine Clinic
City
London
State/Province
Ontario
ZIP/Postal Code
N6A 3K7
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kevin Willits, Md, FRCSC
First Name & Middle Initial & Last Name & Degree
Dianne Bryant, PhD

12. IPD Sharing Statement

Learn more about this trial

Autologous Conditioned Plasma (ACP) for Patients With Plantar Fasciitis

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