Platelet Rich Plasma to Treat Plantar Fasciitis

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2014 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: August 7, 2014
Last verified: January 2014
  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
Device: L-PRP Injection
Drug: Corticosteroid Injection
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:


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 2016
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  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
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, see Learn About Clinical Studies.

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         
Albert Schweitzer Ziekenhuis Recruiting
Dordrecht, Netherlands, 3318
Contact: Peerbooms, PhD    078-6541111 ext +31      
Principal Investigator: Peerbooms, PhD         
Diaconessehuis Recruiting
Leiden, Netherlands
Principal Investigator: H.M. Schuller, PhD         
Sub-Investigator: E Jonxis         
Academisch Ziekenhuis Maastricht Recruiting
Maastricht, Netherlands, 6229
Contact: Hermus, PhD    043 387 6543 ext +31      
Principal Investigator: Hermus, PhD         
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: August 7, 2014
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
Foot Diseases
Musculoskeletal Diseases

ClinicalTrials.gov processed this record on October 30, 2014