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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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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
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

Other trials in Netherlands

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:

  1. Enhancing the influx and proliferation of fibroblasts into the effected area. This will allow for a tissue bed that is extremely receptive to vascularization
  2. Promote angiogenesis to develop a mature vascular structure in the effected area
  3. 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)

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 groups in NCT00758641
Study groupRoleWhat they receive
L-PRP InjectionExperimentalL-PRP produced with Biomet Recover L-PRP Platelet Separation Kit
Receives: Device: L-PRP Injection
Steroid InjectionActive comparatorCorticosteroid injections
Receives: Drug: Corticosteroid Injection

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Percentage of successfully treated patients

    Measured: 6 months

Secondary outcomes (4)
  1. Pain reduction

    Measured: 0-12 months

  2. Function

    Measured: 0-12 months

  3. Patient satisfaction

    Measured: 0-12 months

  4. 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.

  1. First posted25 Sep 2008 (estimated)
  2. Study startSep 2009
  3. Primary completionJan 2016
  4. Study completionJan 2016

Resources

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)
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 31603721
  • Peerbooms 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

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.

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