Treatment of Plantar Fasciitis With Platelet Rich Plasma

Summary

The purpose of this investigator-initiated study is to clinically evaluate the efficacy of a new treatment for plantar fasciitis. This treatment consists of a platelet rich plasma injection into the origin of the plantar fascia. It is thought that plasma rich plasma injection will dramatically improve outcomes for patients suffering from plantar fasciitis.

Subjects will be randomized by choosing a slip of paper from an envelope. This process will randomize 25 patients to the experimental group, and 25 patients to the control. The experimental group will undergo a blood draw, allowing for an injection of platelet rich plasma into the origin of the plantar fascia. The control group will undergo a corticosteroid injection into the plantar fascia as the sole treatment. Patients will be followed for three months for pain, and will fill out questionnaires at the initial visit prior to receiving the injection, as well as six and twelve weeks post injection.

These questionnaires will give insight into functionality and pain changes that the plantar fascia is experiencing due to treatment.

Subjects will be outpatients. Subjects may include employees, students, minorities, and elderly, although no subsets of these will be formed.

Subjects will be between 18 and 89 years of age.

In total, subject participation will last approximately 3 months.

Conditions

• Plantar Fasciitis

Interventions

BIOLOGICAL

platelet rich plasma

30 ml of a patient's own blood will be collected via blood draw, maintaining sterile technique. This will then be spun down using a Magellan Autologous Platelet Separator System, yielding platelet rich plasma (PRP). Under sterile conditions, patients will receive a 3 cc PRP injection (consisting of their own PRP) with 1 cc of 2% lidocaine into the origin of the plantar fascia, administered by an orthopedic surgeon. This will be done using a plantar approach. A peppering technique spreading in clockwise manner will be used to achieve a more expansive zone of delivery, with a maximum of 10 passes through the fascia itself. The patient will be monitored for 10 minutes in clinic for adverse reactions.

DRUG

corticosteroid injection

Under sterile conditions, patients will receive a 4 cc injection consisting of 2 cc Celestone Soluspan (6mg/ml) and 2 cc of 1% lidocaine into the origin of the plantar fascia, administered by an orthopedic surgeon. This will be done using a plantar approach. A peppering technique spreading in clockwise manner will be used to achieve a more expansive zone of delivery, with a maximum of 10 passes through the fascia itself. The patient will be monitored for 10 minutes in clinic for adverse reactions.

Sponsors & Collaborators

• Loma Linda University

  lead OTHER

Principal Investigators

• William P Bunnell, MD · Loma Linda University Department of Orthopaedics

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

89 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2010-05-31

Primary Completion

2011-05-31

Completion

2011-05-31

Countries

• United States