Chronic Plantar FasciitisNCT01614223
Autologous Conditioned Plasma (ACP) for Patients With Plantar Fasciitis
A study testing ACP and Corticosteroid (celestone) injection in people with Chronic Plantar Fasciitis, run by University of Western Ontario, Canada at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Plantar Fasciitis
- What is being tested?
- ACP and Corticosteroid (celestone) injection
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 1 siteCanada
- Study dates
- Sep 2010to Sep 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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.
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
Fowler Kennedy Sport Medicine Clinic
London, Ontario, N6A 3K7
Kevin Willits, Md, FRCSC
Dianne Bryant, PhD
About this study
Official title: A Randomized Double-Blind Clinical Trial to Investigate the Use of Autologous Conditioned Plasma (ACP) for Patients With Plantar Fasciitis
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
- Conditions
- Chronic Plantar Fasciitis
- Being tested
- ACP, Corticosteroid (celestone) injection
- Keywords
- Plantar fasciitis, Autologous Conditioned Plasma
- Medical subject headings
- Fasciitis, Plantar
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ACPProcedure or surgery
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.
Corticosteroid (celestone) injectionDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| ACP treatment | Active comparator | Not described Receives: Procedure: ACP |
| Corticosteroid treatment | Active comparator | Not described Receives: Drug: Corticosteroid (celestone) injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 weeks, 3, 6 and 12 months
Secondary outcomes (2)
Plantar Fasciitis Pain/Disability Scale (PFPD
Measured: 6 weeks, 3, 6 and 12 months
SF-12
Measured: 6 weeks, 3,6,12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2012 (estimated)
- Study startSep 2010
- Primary completionSep 2015 (estimated)
- Study completionSep 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Plantar FasciitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 140 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Western Ontario, Canada
- Sponsor type
- University, hospital or other
- Collaborators
- Arthrex, Inc.
- Responsible party
- Principal investigator, Dianne Bryant, University of Western Ontario, Canada
- Investigators
- Dianne Bryant, PhD, Study director, The University of Western Ontario
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01614223
- Sponsor's protocol ID
- FKSCM 2010 -1
- Status last verified
- Apr 2014
- First submitted
- 4 Jun 2012
- Last updated
- 25 Apr 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Double-Blind Clinical Trial to Investigate the Use of Autologous Conditioned Plasma (ACP) for Patients With Plantar Fasciitis
- ClinicalTrials.gov ID
- NCT01614223
- Acronym / sponsor ID
- FKSCM 2010 -1
- Conditions
- Chronic Plantar Fasciitis
- Keywords
- Plantar fasciitis, Autologous Conditioned Plasma
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 140 participants (estimated)
- Lead sponsor
- University of Western Ontario, CanadaUniversity, hospital or other
- Collaborators
- Arthrex, Inc.
- Study start
- Sep 2010
- Primary completion
- Sep 2015 (estimated)
- Study completion
- Sep 2015 (estimated)
- First posted
- 7 Jun 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ACP treatment | Active comparator | Procedure: ACP |
| Corticosteroid treatment | Active comparator | Drug: Corticosteroid (celestone) injection |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ACPWithin 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. | Procedure or surgery | ACP treatment |
| Corticosteroid (celestone) injectionPreparation 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. | Drug | Corticosteroid treatment |
Primary outcome
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.
2 secondary outcomes
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Apr 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dianne Bryant, PhD study director
The University of Western Ontario
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ACP and Corticosteroid (celestone) injection in people with Chronic Plantar Fasciitis, run by University of Western Ontario, Canada at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 25 Apr 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Dianne Bryant, PhD (519-661-2111 ext. 80349, dianne.bryant@uwo.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
American Orthopaedic Foot and Ankle Midfoot Scale (AOFAS) (time frame: 6 weeks, 3, 6 and 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Apr 2014.