Status:
COMPLETED
Platelet Rich Plasma to Treat Plantar Fasciitis
Lead Sponsor:
Zimmer Biomet
Collaborating Sponsors:
Elisabeth-TweeSteden Ziekenhuis
Diaconessenhuis Leiden Netherlands
Conditions:
Plantar Fasciitis
Eligibility:
All Genders
18+ years
Phase:
PHASE4
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 natu...
Detailed Description
Plantar fasciitis is the most common cause of foot complaints in the United States, making up 11 to 15 percent of the foot symptoms requiring professional care among adults (Pfeffer et al., 1999; Cole...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2016
Estimated Enrollment :
115 Patients enrolled
Trial Details
Trial ID
NCT00758641
Start Date
September 1 2009
End Date
January 1 2016
Last Update
March 14 2017
Active Locations (5)
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1
Haga ziekenhuis
DenHaag, Netherlands
2
Albert Schweitzer Ziekenhuis
Dordrecht, Netherlands, 3318
3
Diaconessehuis
Leiden, Netherlands
4
Academisch Ziekenhuis Maastricht
Maastricht, Netherlands, 6229