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Platelet Rich Plasma to Treat Plantar Fasciitis

This study is currently recruiting participants.
Verified May 2013 by Biomet, Inc.
Sponsor:
Collaborators:
St. Elisabeth Hospital, Tilburg, Netherlands
Diaconessenhuis Leiden Netherlands
Biomet Nederland BV
Information provided by (Responsible Party):
Biomet, Inc.
ClinicalTrials.gov Identifier:
NCT00758641
First received: September 22, 2008
Last updated: May 14, 2013
Last verified: May 2013
History of Changes
  Purpose

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 Intervention Phase
Plantar Fasciitis
 Biological: PRP obtained with GPS
Drug: kenacort 40 mg/ml triamcinolon acetonide
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Use of PRP to Treat Plantar Fasciitis, Blinded and Randomized as a Multi Center Study

Resource links provided by NLM:

MedlinePlus related topics: Steroids
U.S. FDA Resources

Further study details as provided by Biomet, Inc.:

Primary Outcome Measures:
  • Percentage of successfully treated patients [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Pain reduction [ Time Frame: 0-12 months ] [ Designated as safety issue: No ]
  • Function [ Time Frame: 0-12 months ] [ Designated as safety issue: No ]
  • Patient satisfaction [ Time Frame: 0-12 months ] [ Designated as safety issue: No ]
  • Complications and reinventions [ Time Frame: 0-12 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 120
Study Start Date: September 2009
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A
PRP obtained with GPS tm
 Biological: PRP obtained with GPS
PRP obtained with GPS
Other Name: PRP obtained with GPS
Active Comparator: B
Corticosteroid
 Drug: kenacort 40 mg/ml triamcinolon acetonide
kenacort 40 mg/ml triamcinolon acetonide
Other Name: Corticosteroid

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00758641

Contacts
Contact: T Gosens, MD, PhD t.gosens@elisabeth.nl

Locations
Netherlands
Haga ziekenhuis Recruiting
DenHaag, Netherlands
Contact: F.W.M. Faber, MD, PhD            
Principal Investigator: F.W.M. Faber, PhD            
Diaconessehuis Recruiting
Leiden, Netherlands
Principal Investigator: H.M. Schuller, PhD            
Sub-Investigator: E Jonxis            
st. Antonius ziekenhuis Withdrawn
Nieuwegein, Netherlands
St Elisabeth Hospital Recruiting
Tilburg, Netherlands
Principal Investigator: T Gosens, PhD            
Sponsors and Collaborators
Biomet, Inc.
St. Elisabeth Hospital, Tilburg, Netherlands
Diaconessenhuis Leiden Netherlands
Biomet Nederland BV
Investigators
Principal Investigator: T Gosens, MD, PhD St Elisabeth Hospital
Principal Investigator: H.M. Schuller, PhD, MD Diaconessehuis Leiden
  More Information

No publications provided by Biomet, Inc.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Biomet, Inc.
ClinicalTrials.gov Identifier: NCT00758641     History of Changes
Other Study ID Numbers: BiometNL_16400076, Eudradact 2008-001257-18, CCMO 22305.008.08 BI
Study First Received: September 22, 2008
Last Updated: May 14, 2013
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
Netherlands: Medical Ethics Review Committee (METC)

Keywords provided by Biomet, Inc.:
plantar fasciitis
platelet rich plasma
GPS

Additional relevant MeSH terms:
Fasciitis
Fasciitis, Plantar
Musculoskeletal Diseases
Foot Diseases
Triamcinolone hexacetonide
Triamcinolone
Triamcinolone Acetonide
Triamcinolone diacetate
Anti-Inflammatory Agents
Therapeutic Uses
 Pharmacologic Actions
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Immunosuppressive Agents
Immunologic Factors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on June 17, 2013