Platelet Rich Plasma to Treat Plantar Fasciitis - Full Text View

Sponsor:	Biomet, Inc.
Collaborators:	St. Elisabeth Hospital, Tilburg, Netherlands Diaconessenhuis Leiden Netherlands Biomet Nederland BV
Information provided by (Responsible Party):	Biomet, Inc.
ClinicalTrials.gov Identifier:	NCT00758641

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 IV

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:

Drug Information available for: Triamcinolone diacetate Triamcinolone acetonide Triamcinolone Triamcinolone hexacetonide Corticosteroids

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:	February 2013
Estimated Primary Completion Date:	February 2012 (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	Not yet recruiting
Nieuwegein, Netherlands
Contact: H van der Hoeven, MD,PhD
Principal Investigator: Henk van der Hoeven, PhD
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):

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.

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 26, 2011
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 February 09, 2012