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Clinical Trials/EUCTR2008-001257-18-NL
EUCTR2008-001257-18-NL
Active, Not Recruiting
N/A

se of PRP to treat plantar fasciitis, blinded and randomized as a multi center study - PRP to treat Plantar fasciitis

Biomet Nederland BV0 sitesSeptember 11, 2008

Overview

Phase
N/A
Intervention
Not specified
Conditions
Not specified
Sponsor
Biomet Nederland BV
Status
Active, Not Recruiting
Last Updated
14 years ago

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
September 11, 2008
End Date
TBD
Last Updated
14 years ago
Study Type
Interventional clinical trial of medicinal product
Sex
All

Investigators

Sponsor
Biomet Nederland BV

Eligibility 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 by starting up higher as 5 (0\-10 scale)
  • Are the trial subjects under 18? no
  • Number of subjects for this age range:
  • F.1\.2 Adults (18\-64 years) yes
  • F.1\.2\.1 Number of subjects for this age range

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
  • (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
  • No other painful or function limited disorders of the foot and ankle

Outcomes

Primary Outcomes

Not specified

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