Overview

Platelet Rich Plasma to Treat Plantar Fasciitis

Status:
Completed
Trial end date:
2016-01-01
Target enrollment:
0
Participant gender:
All
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 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.
Phase:
Phase 4
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Biomet, Inc.
Zimmer Biomet
Collaborators:
Biomet Nederland BV
Diaconessenhuis Leiden Netherlands
Elisabeth-TweeSteden Ziekenhuis
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