Platelet Rich Plasma to Treat Plantar Fasciitis
Information source: Biomet, Inc.
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Plantar Fasciitis
Intervention: L-PRP Injection (Device); Corticosteroid Injection (Drug)
Phase: Phase 4
Status: Recruiting
Sponsored by: Biomet, Inc. Official(s) and/or principal investigator(s): T Gosens, MD, PhD, Principal Investigator, Affiliation: St Elisabeth Hospital H.M. Schuller, PhD, MD, Principal Investigator, Affiliation: Diaconessehuis Leiden
Overall contact: T Gosens, MD, PhD, Email: t.gosens@elisabeth.nl
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. 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.
Clinical Details
Official title: Use of PRP to Treat Plantar Fasciitis, Blinded and Randomized as a Multi Center Study
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Primary outcome: Percentage of successfully treated patients
Secondary outcome: Pain reductionFunction Patient satisfaction Complications and reinventions
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)
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- 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)
Exclusion Criteria:
- 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 )
- 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
Locations and Contacts
T Gosens, MD, PhD, Email: t.gosens@elisabeth.nl
Haga ziekenhuis, DenHaag, Netherlands; Recruiting F.W.M. Faber, MD, PhD F.W.M. Faber, PhD, Principal Investigator
Albert Schweitzer Ziekenhuis, Dordrecht 3318, Netherlands; Recruiting Peerbooms, PhD, Phone: 078-6541111, Ext: +31 Peerbooms, PhD, Principal Investigator
Diaconessehuis, Leiden, Netherlands; Recruiting H.M. Schuller, PhD, Principal Investigator E Jonxis, Sub-Investigator
Academisch Ziekenhuis Maastricht, Maastricht 6229, Netherlands; Recruiting Hermus, PhD, Phone: 043 387 6543, Ext: +31 Hermus, PhD, Principal Investigator
st. Antonius ziekenhuis, Nieuwegein, Netherlands; Withdrawn
St Elisabeth Hospital, Tilburg, Netherlands; Recruiting T Gosens, PhD, Principal Investigator
Additional Information
Starting date: September 2009
Last updated: March 12, 2015
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