This site became the new ClinicalTrials.gov on June 19th. Learn more.
Show more
ClinicalTrials.gov Menu IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more...
ClinicalTrials.gov Menu IMPORTANT: Talk with a trusted healthcare professional before volunteering for a study. Read more...
ClinicalTrials.gov Menu
Give us feedback

Platelet Rich Plasma to Treat Plantar Fasciitis

This study has been completed.
Sponsor:
Collaborators:
Elisabeth-TweeSteden Ziekenhuis
Diaconessenhuis Leiden Netherlands
Biomet Nederland BV
Information provided by (Responsible Party):
Zimmer Biomet
ClinicalTrials.gov Identifier:
NCT00758641
First received: September 22, 2008
Last updated: March 13, 2017
Last verified: June 2016
  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
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

Resource links provided by NLM:


Further study details as provided by Zimmer Biomet:

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

Secondary Outcome Measures:
  • Pain reduction [ Time Frame: 0-12 months ]
  • Function [ Time Frame: 0-12 months ]
  • Patient satisfaction [ Time Frame: 0-12 months ]
  • Complications and reinventions [ Time Frame: 0-12 months ]

Enrollment: 115
Study Start Date: September 2009
Study Completion Date: January 2016
Primary Completion Date: January 2016 (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   (Adult, Senior)
Sexes Eligible for Study:   All
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

Locations
Netherlands
Haga ziekenhuis
DenHaag, Netherlands
Albert Schweitzer Ziekenhuis
Dordrecht, Netherlands, 3318
Diaconessehuis
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
Investigators
Principal Investigator: T Gosens, MD, PhD St Elisabeth Hospital
Principal Investigator: H.M. Schuller, PhD, MD Diaconessehuis Leiden
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Zimmer Biomet
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: March 13, 2017

Keywords provided by Zimmer Biomet:
plantar fasciitis
platelet rich plasma
GPS

Additional relevant MeSH terms:
Fasciitis
Fasciitis, Plantar
Musculoskeletal Diseases
Foot Diseases

ClinicalTrials.gov processed this record on September 20, 2017