Plantar FasciitisPhase 4NCT00758641
Platelet Rich Plasma to Treat Plantar Fasciitis
A Phase 4 study testing L-PRP Injection and Corticosteroid Injection in people with Plantar Fasciitis, run by Zimmer Biomet at 5 sites in Netherlands.
Trial summary
Rationale: The standard treatment of chronic plantar fasciitis is corticosteroid injections. Corticosteroid injection give temporarily pain reduction, but no healing. Blood platelets initiate the natural healing rate. GPS ® gives an eightfold concentrate platelets of patients own blood. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Plantar Fasciitis
- What is being tested?
- L-PRP Injection and Corticosteroid Injection
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 115 participants
- Where
- 5 sitesNetherlands
- Study dates
- Sep 2009to Jan 2016
- Phase
- Phase 4
- 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
- No bias to sex
- > 18 years
- Chronic plantar fasciitis or proximal recalcitrant plantar heel pain (6-12 months duration)
- Failed conservative treatment
- Able to understand the informed consent
- VAS pain in morning by first steps higher as 5 (0-10 scale)
Who cannot join
- Received local steroid injections within 6 weeks, physical/occupational therapies within 4 weeks, or non-steroidal anti-inflammatory within 1 week prior to randomization
- Inability to fulfil follow-up criteria
- Significant cardiovascular, renal or hepatic disease
- Pregnant
- (Local) malignancy
- History of amenia (hemoglobin < 5.0 )
Show all 12Show fewer
- Previous surgery for plantar fasciitis
- Active bilateral plantar fasciitis
- Diagnosis of vascular insufficiency or neuropathy related to heel pain
- Hypothyroidism
- Diabetics
- No other painful or function limited disorders of the foot and ankle
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
Netherlands5 sites
Haga ziekenhuis
DenHaag
Albert Schweitzer Ziekenhuis
Dordrecht, 3318
Diaconessehuis
Leiden
Academisch Ziekenhuis Maastricht
Maastricht, 6229
St Elisabeth Hospital
Tilburg
About this study
Official title: Use of PRP to Treat Plantar Fasciitis, Blinded and Randomized as a Multi Center Study
Rationale: The standard treatment of chronic plantar fasciitis is corticosteroid injections. Corticosteroid injection give temporarily pain reduction, but no healing. Blood platelets initiate the natural healing rate. GPS ® gives an eightfold concentrate platelets of patients own blood. Injection of these platelets in the tendon might induce a healing rate.
Objective: To compare the efficacy of autologous platelet concentrate injections with corticosteroid injection in patients suffering from plantar fasciitis with respect to pain and function.
Read the detailed description
Plantar fasciitis is the most common cause of foot complaints in the United States, making up 11 to 15 percent of the foot symptoms requiring professional care among adults (Pfeffer et al., 1999; Cole et al., 2005). A 2004 publication found that there are approximately 1 million patient visits per year to office-based physicians and hospital outpatient departments in the United States for plantar fasciitis (Riddle et al., 2004). This figure does not consider podiatric physicians visits, including these numbers would raise the overall physician visits related to plantar fasciitis considerably. The incidence of plantar fasciitis peaks in people between the ages of 40 to 60 years with no bias towards either sex (Taunton et al., 2002) The underlying condition that causes plantar fasciitis is a degenerative tissue condition that occurs near the site of origin of the plantar fascia at the medial tuberosity of the calcaneous (Buchbinder, 2004). In acute cases, plantar fasciitis is characterized by classical signs of inflammation including pain, swelling and loss of function. For more chronic conditions, however, inflammation is not the underlying tissue disruption. In fact, histology of chronic cases has shown no signs of inflammatory cell invasion into the affected area (Lemont et al., 2003). The tissue instead is characterized histological by infiltration with macrophages, lymphocytes, and plasma cells; tissue destruction; and repair involving immature vascularization and fibrosis (Lemont et al., 2003). The normal fascia tissue is replaced by an angiofibroblastic hyperplastic tissue which insuitates itself throughout the surrounding tissue creating a self-perpetuating cycle of degeneration (Lemont et al., 2003). In these chronic cases, the suffix 'itis' is a misnomer with plantar fasciosis being a more apt description of the underlying histology.
Conservative treatments including stretching protocols and foot orthoses resolve many cases of plantar fasciitis, with reports for patients in orthopedic practices being around 80 percent resolution (Cole et al., 2005; Wolgin et al., 1994; Martin et al., 1998; Davies et al., 1999). For more chronic cases, a number of non-surgical interventions are utilized including extracorperal shock wave therapy and corticosteroid injections (Cole et al., 2005; Speed et al., 2003; Acevedo, Beskin, 1998). The use of corticosteroids is particularly troubling as several studies have linked plantar fascial rupture to repeated local injections of a corticosteroid (Cole et al., 2005; Sellman, 1994; Leach et al., 1978; Acevedo, Beskin, 1998).
All of these methods are limited in their efficacy for cases of chronic plantar fasciitis due to the fact that none of them adequately addresses the full scope of the underlying tissue degeneration. This frequently leaves surgical intervention as the only viable option in these chronic cases.
The goal of treatment for chronic plantar fasciitis should be to cease and ultimately reverse the degenerating tissue disruption that is at the root of the condition. The three steps critical to full repair of the effected tissue are:
- Enhancing the influx and proliferation of fibroblasts into the effected area. This will allow for a tissue bed that is extremely receptive to vascularization
- Promote angiogenesis to develop a mature vascular structure in the effected area
- With a mature vascularization, collagen deposition can then occur, resulting in the organization of fully mature tendon tissue
The injection of platelet-rich-plasma (PRP) into the effected tissue addresses all three healing stages necessary to reverse the degenerative process. The individual cytokines present in the platelet α-granules have been shown to enhance fibroblast migration and proliferation, upregulate vascularization, and increases collagen deposition in a variety of in vitro and in vivo settings [Molloy 2004]. Autologous PRP contains concentrated white blood cells and platelets that are suspended in plasma. Since an acidic anticoagulant (Anticoagulant Citrate Dextrose Solution A) is used to allow for processing of the whole blood via centrifugation, the PRP must be buffered to increase the pH to normal physiologic levels prior for injection into the effected tissue. This is accomplished with the addition of an 8.4% sodium bicarbonate solution at a ratio 0.05cc of sodium bicarbonate solution to 1cc of platelet concentrate. The resulting buffered platelet concentrate contains approximately 6 to 8 times concentration of platelets compared to baseline whole blood.
The cytokines present in platelet α-granules have been shown to affect the three healing stages necessary to reverse a chronic plantar fasciitis condition (Molloy et al., 2003). Additionally, many of these cytokines have been seen to work in a dose dependent manner (Molloy et al., 2003). A PRP injection into the effected area of tissue would provide concentrated levels of cytokines that should result in a healing cascade that halts and ultimately reverses the underlying pathology of elbow tendinosis. This treatment concept directly addresses the existing condition and should prove to be a superior alternative to current conservative treatments for chronic plantar fasciitis.
The objective of this clinical investigation is to compare the efficacy of autologous platelet concentrate injections with corticosteroid injection in patients suffering from plantar fasciitis with respect to pain and function.
Primary question Does injection with autologous platelet concentrate results in a larger percentage of successfully treated patients after 6 month as injection corticosteroid injection?
Secondary questions Does injection with autologous platelet concentrate has a larger pain reduction as injection of corticosteroid injection? (VAS) Does injection with autologous platelet concentrate has a larger improvement in function as corticosteroid injection? (AOFAS, WHOQol) Does injection with autologous platelet concentrate has a larger amount of satisfied patients as of corticosteroid injection? (WHOQol, satisfaction)
- Conditions
- Plantar Fasciitis
- Being tested
- L-PRP Injection, Corticosteroid Injection
- Keywords
- plantar fasciitis, platelet rich plasma, GPS
- Medical subject headings
- Fasciitis, Plantar
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
L-PRP InjectionDevice
L-PRP produced with Biomet Recover L-PRP Platelet Separation Kit
Corticosteroid InjectionDrug
Also called Corticosteroid
kenacort 40 mg/ml triamcinolon acetonide
| Study group | Role | What they receive |
|---|---|---|
| L-PRP Injection | Experimental | L-PRP produced with Biomet Recover L-PRP Platelet Separation Kit Receives: Device: L-PRP Injection |
| Steroid Injection | Active comparator | Corticosteroid injections Receives: Drug: Corticosteroid Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of successfully treated patients
Measured: 6 months
Secondary outcomes (4)
Pain reduction
Measured: 0-12 months
Function
Measured: 0-12 months
Patient satisfaction
Measured: 0-12 months
Complications and reinventions
Measured: 0-12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2008 (estimated)
- Study startSep 2009
- Primary completionJan 2016
- Study completionJan 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Plantar FasciitisStudies of the same condition, open and under way.
- More trials run by Zimmer BiometThe sponsor's other registered studies.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 115 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zimmer Biomet
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Elisabeth-TweeSteden Ziekenhuis, Diaconessenhuis Leiden Netherlands, Biomet Nederland BV
- Responsible party
- Sponsor
- Investigators
- T Gosens, MD, PhD, Principal investigator, St Elisabeth HospitalH.M. Schuller, PhD, MD, Principal investigator, Diaconessehuis Leiden
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00758641
- Sponsor's protocol ID
- BiometNL_16400076
- Other IDs
- Eudradact 2008-001257-18, CCMO 22305.008.08 BI
- Status last verified
- Jun 2016
- First submitted
- 22 Sep 2008
- Last updated
- 14 Mar 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Peerbooms JC, Lodder P, den Oudsten BL, Doorgeest K, Schuller HM, Gosens T. Positive Effect of Platelet-Rich Plasma on Pain in Plantar Fasciitis: A Double-Blind Multicenter Randomized Controlled Trial. Am J Sports Med. 2019 Nov;47(13):3238-3246. doi: 10.1177/0363546519877181. Epub 2019 Oct 11.
PubMed 31603721Peerbooms JC, van Laar W, Faber F, Schuller HM, van der Hoeven H, Gosens T. Use of platelet rich plasma to treat plantar fasciitis: design of a multi centre randomized controlled trial. BMC Musculoskelet Disord. 2010 Apr 14;11:69. doi: 10.1186/1471-2474-11-69.
PubMed 20398269
Study at a glance
From the registry record, last updated by the sponsor on 14 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of PRP to Treat Plantar Fasciitis, Blinded and Randomized as a Multi Center Study
- ClinicalTrials.gov ID
- NCT00758641
- Acronym / sponsor ID
- BiometNL_16400076
- Conditions
- Plantar Fasciitis
- Keywords
- plantar fasciitis, platelet rich plasma, GPS
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 115 participants (actual)
- Lead sponsor
- Zimmer BiometIndustry (pharma, biotech, devices)
- Collaborators
- Elisabeth-TweeSteden Ziekenhuis, Diaconessenhuis Leiden Netherlands, Biomet Nederland BV
- Study start
- Sep 2009
- Primary completion
- Jan 2016 (actual)
- Study completion
- Jan 2016 (actual)
- First posted
- 25 Sep 2008 (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.
Rationale: The standard treatment of chronic plantar fasciitis is corticosteroid injections. Corticosteroid injection give temporarily pain reduction, but no healing. Blood platelets initiate the natural healing rate. GPS ® gives an eightfold concentrate platelets of patients own blood. Injection of these platelets in the tendon might induce a healing rate.
Objective: To compare the efficacy of autologous platelet concentrate injections with corticosteroid injection in patients suffering from plantar fasciitis with respect to pain and function.
Detailed description
Plantar fasciitis is the most common cause of foot complaints in the United States, making up 11 to 15 percent of the foot symptoms requiring professional care among adults (Pfeffer et al., 1999; Cole et al., 2005). A 2004 publication found that there are approximately 1 million patient visits per year to office-based physicians and hospital outpatient departments in the United States for plantar fasciitis (Riddle et al., 2004). This figure does not consider podiatric physicians visits, including these numbers would raise the overall physician visits related to plantar fasciitis considerably. The incidence of plantar fasciitis peaks in people between the ages of 40 to 60 years with no bias towards either sex (Taunton et al., 2002) The underlying condition that causes plantar fasciitis is a degenerative tissue condition that occurs near the site of origin of the plantar fascia at the medial tuberosity of the calcaneous (Buchbinder, 2004). In acute cases, plantar fasciitis is characterized by classical signs of inflammation including pain, swelling and loss of function. For more chronic conditions, however, inflammation is not the underlying tissue disruption. In fact, histology of chronic cases has shown no signs of inflammatory cell invasion into the affected area (Lemont et al., 2003). The tissue instead is characterized histological by infiltration with macrophages, lymphocytes, and plasma cells; tissue destruction; and repair involving immature vascularization and fibrosis (Lemont et al., 2003). The normal fascia tissue is replaced by an angiofibroblastic hyperplastic tissue which insuitates itself throughout the surrounding tissue creating a self-perpetuating cycle of degeneration (Lemont et al., 2003). In these chronic cases, the suffix 'itis' is a misnomer with plantar fasciosis being a more apt description of the underlying histology.
Conservative treatments including stretching protocols and foot orthoses resolve many cases of plantar fasciitis, with reports for patients in orthopedic practices being around 80 percent resolution (Cole et al., 2005; Wolgin et al., 1994; Martin et al., 1998; Davies et al., 1999). For more chronic cases, a number of non-surgical interventions are utilized including extracorperal shock wave therapy and corticosteroid injections (Cole et al., 2005; Speed et al., 2003; Acevedo, Beskin, 1998). The use of corticosteroids is particularly troubling as several studies have linked plantar fascial rupture to repeated local injections of a corticosteroid (Cole et al., 2005; Sellman, 1994; Leach et al., 1978; Acevedo, Beskin, 1998).
All of these methods are limited in their efficacy for cases of chronic plantar fasciitis due to the fact that none of them adequately addresses the full scope of the underlying tissue degeneration. This frequently leaves surgical intervention as the only viable option in these chronic cases.
The goal of treatment for chronic plantar fasciitis should be to cease and ultimately reverse the degenerating tissue disruption that is at the root of the condition. The three steps critical to full repair of the effected tissue are:
- Enhancing the influx and proliferation of fibroblasts into the effected area. This will allow for a tissue bed that is extremely receptive to vascularization
- Promote angiogenesis to develop a mature vascular structure in the effected area
- With a mature vascularization, collagen deposition can then occur, resulting in the organization of fully mature tendon tissue
The injection of platelet-rich-plasma (PRP) into the effected tissue addresses all three healing stages necessary to reverse the degenerative process. The individual cytokines present in the platelet α-granules have been shown to enhance fibroblast migration and proliferation, upregulate vascularization, and increases collagen deposition in a variety of in vitro and in vivo settings [Molloy 2004]. Autologous PRP contains concentrated white blood cells and platelets that are suspended in plasma. Since an acidic anticoagulant (Anticoagulant Citrate Dextrose Solution A) is used to allow for processing of the whole blood via centrifugation, the PRP must be buffered to increase the pH to normal physiologic levels prior for injection into the effected tissue. This is accomplished with the addition of an 8.4% sodium bicarbonate solution at a ratio 0.05cc of sodium bicarbonate solution to 1cc of platelet concentrate. The resulting buffered platelet concentrate contains approximately 6 to 8 times concentration of platelets compared to baseline whole blood.
The cytokines present in platelet α-granules have been shown to affect the three healing stages necessary to reverse a chronic plantar fasciitis condition (Molloy et al., 2003). Additionally, many of these cytokines have been seen to work in a dose dependent manner (Molloy et al., 2003). A PRP injection into the effected area of tissue would provide concentrated levels of cytokines that should result in a healing cascade that halts and ultimately reverses the underlying pathology of elbow tendinosis. This treatment concept directly addresses the existing condition and should prove to be a superior alternative to current conservative treatments for chronic plantar fasciitis.
The objective of this clinical investigation is to compare the efficacy of autologous platelet concentrate injections with corticosteroid injection in patients suffering from plantar fasciitis with respect to pain and function.
Primary question Does injection with autologous platelet concentrate results in a larger percentage of successfully treated patients after 6 month as injection corticosteroid injection?
Secondary questions Does injection with autologous platelet concentrate has a larger pain reduction as injection of corticosteroid injection? (VAS) Does injection with autologous platelet concentrate has a larger improvement in function as corticosteroid injection? (AOFAS, WHOQol) Does injection with autologous platelet concentrate has a larger amount of satisfied patients as of corticosteroid injection? (WHOQol, satisfaction)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| L-PRP Injection | Experimental | Device: L-PRP InjectionL-PRP produced with Biomet Recover L-PRP Platelet Separation Kit |
| Steroid Injection | Active comparator | Drug: Corticosteroid InjectionCorticosteroid injections |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- No bias to sex
- > 18 years
- Chronic plantar fasciitis or proximal recalcitrant plantar heel pain (6-12 months duration)
- Failed conservative treatment
- Able to understand the informed consent
Key exclusion criteria (12 listed)
- Received local steroid injections within 6 weeks, physical/occupational therapies within 4 weeks, or non-steroidal anti-inflammatory within 1 week prior to randomization
- Inability to fulfil follow-up criteria
- Significant cardiovascular, renal or hepatic disease
- Pregnant
- (Local) malignancy
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 |
|---|---|---|
| L-PRP InjectionL-PRP produced with Biomet Recover L-PRP Platelet Separation Kit | Device | L-PRP Injection |
| Corticosteroid InjectionAlso: Corticosteroidkenacort 40 mg/ml triamcinolon acetonide | Drug | Steroid Injection |
Primary outcome
Percentage of successfully treated patients
Time frame: 6 months
4 secondary outcomes
Pain reduction
Time frame: 0-12 months
Function
Time frame: 0-12 months
Patient satisfaction
Time frame: 0-12 months
Complications and reinventions
Time frame: 0-12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Mar 2017.
- Derived from this study: PubMed 31603721Peerbooms JC, Lodder P, den Oudsten BL, Doorgeest K, Schuller HM, Gosens T. Positive Effect of Platelet-Rich Plasma on Pain in Plantar Fasciitis: A Double-Blind Multicenter Randomized Controlled Trial. Am J Sports Med. 2019 Nov;47(13):3238-3246. doi: 10.1177/0363546519877181. Epub 2019 Oct 11.
- Derived from this study: PubMed 20398269Peerbooms JC, van Laar W, Faber F, Schuller HM, van der Hoeven H, Gosens T. Use of platelet rich plasma to treat plantar fasciitis: design of a multi centre randomized controlled trial. BMC Musculoskelet Disord. 2010 Apr 14;11:69. doi: 10.1186/1471-2474-11-69.
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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.
T Gosens, MD, PhD principal investigator
St Elisabeth Hospital
H.M. Schuller, PhD, MD principal investigator
Diaconessehuis Leiden
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing L-PRP Injection and Corticosteroid Injection in people with Plantar Fasciitis, run by Zimmer Biomet at 5 sites in Netherlands.
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 6 inclusion and 12 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: finished, as of the sponsor's last update on 14 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Netherlands. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of successfully treated patients (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00758641, which also lists 2 linked publications.
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 14 Mar 2017.