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Platelet Rich Plasma to Treat Plantar Fasciitis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00758641
Recruitment Status : Completed
First Posted : September 25, 2008
Last Update Posted : March 14, 2017
Elisabeth-TweeSteden Ziekenhuis
Diaconessenhuis Leiden Netherlands
Biomet Nederland BV
Information provided by (Responsible Party):
Zimmer Biomet

Brief 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.

Condition or disease Intervention/treatment Phase
Plantar Fasciitis Device: L-PRP Injection Drug: Corticosteroid Injection Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 115 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Use of PRP to Treat Plantar Fasciitis, Blinded and Randomized as a Multi Center Study
Study Start Date : September 2009
Actual Primary Completion Date : January 2016
Actual Study Completion Date : January 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Steroids

Arm Intervention/treatment
Experimental: L-PRP Injection
L-PRP produced with Biomet Recover L-PRP Platelet Separation Kit
Device: L-PRP Injection
L-PRP produced with Biomet Recover L-PRP Platelet Separation Kit

Active Comparator: Steroid Injection
Corticosteroid injections
Drug: Corticosteroid Injection
kenacort 40 mg/ml triamcinolon acetonide
Other Name: Corticosteroid

Primary Outcome Measures :
  1. Percentage of successfully treated patients [ Time Frame: 6 months ]

Secondary Outcome Measures :
  1. Pain reduction [ Time Frame: 0-12 months ]
  2. Function [ Time Frame: 0-12 months ]
  3. Patient satisfaction [ Time Frame: 0-12 months ]
  4. Complications and reinventions [ Time Frame: 0-12 months ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00758641

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Haga ziekenhuis
DenHaag, Netherlands
Albert Schweitzer Ziekenhuis
Dordrecht, Netherlands, 3318
Leiden, Netherlands
Academisch Ziekenhuis Maastricht
Maastricht, Netherlands, 6229
St Elisabeth Hospital
Tilburg, Netherlands
Sponsors and Collaborators
Zimmer Biomet
Elisabeth-TweeSteden Ziekenhuis
Diaconessenhuis Leiden Netherlands
Biomet Nederland BV
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Principal Investigator: T Gosens, MD, PhD St Elisabeth Hospital
Principal Investigator: H.M. Schuller, PhD, MD Diaconessehuis Leiden
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Zimmer Biomet Identifier: NCT00758641    
Other Study ID Numbers: BiometNL_16400076
Eudradact 2008-001257-18
CCMO 22305.008.08 BI
First Posted: September 25, 2008    Key Record Dates
Last Update Posted: March 14, 2017
Last Verified: June 2016
Keywords provided by Zimmer Biomet:
plantar fasciitis
platelet rich plasma
Additional relevant MeSH terms:
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Fasciitis, Plantar
Musculoskeletal Diseases
Foot Diseases