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