se of PRP to treat plantar fasciitis, blinded and randomized as a multi center study - PRP to treat Plantar fasciitis
- Conditions
- Patients with plantar fasciitis
- Registration Number
- EUCTR2008-001257-18-NL
- Lead Sponsor
- Biomet Nederland BV
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- Not specified
•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
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
•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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method