Study of Effectiveness and Safety of Extracorporeal Shock Wave Therapy (ESWT) for Treatment of Painful Heel Syndrome

Completed · Phase 3 · Has a placebo group

Conditions studied: Plantar Fasciitis

In brief

The purpose of this study is to determine if the Storz Duolith SD1 is more effective than placebo for treatment of heel pain syndrome for patients who have failed conservative treatment with other therapies.

Key facts

Study ID

NCT00720694

Run by

Storz Medical AG

People needed

250

Starts

2006-06-01

Last updated by the study team

2018-02-19

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Age greater than 18 years
• ability of subject or legal respondent to give written informed consent
• signed informed consent
• diagnosis of painful heel syndrome
• 6 months of unsuccessful conservative treatment
• washout from conservative treatment
• scores of 5 or greater on three VAS scales
• score of 3 or 4 on Roles and Maudsley Scale
• willingness to refrain from specified concomitant therapies
• willingness to keep subject diaries
• negative urine pregnancy test (if applicable) required use of contraception (if applicable)

You may not qualify if…

• tendon rupture, neurological or vascular insufficiencies
• inflammation of lower and upper ankle
• history of rheumatic disease, collagen, or metabolic disorders
• history of hyperthyroidism
• active malignant disease with or without metastasis
• Paget disease or calcaneal fat pad atrophy
• osteomyelitis
• fracture of calcaneus
• immunosuppressive therapy
• long term (6 months or greater) treatment with corticosteroid
• insulin dependent diabetes, severe cardiac or respiratory disease
• coagulation disorder or therapy with anticoagulants or antiplatelet drugs
• bilateral painful heel
• planned treatment within 8 weeks of enrollment that may confound pain results
• less than required washout of other treatments
• previous surgery for painful heel
• previous unsuccessful treatment for painful heel with shock wave device
• history of allergy or hypersensitivity to local anesthetics
• significant abnormalities of hepatic function
• poor physical condition
• pregnant female
• active infection or history of chronic infection in treatment area
• history of peripheral neuropathy
• history of systemic inflammatory disease
• history of worker's compensation or litigation

Where it is running

• Palo Alto Medical Fondation — Palo Alto, California, United States
• Connecticut Orthopedics Specialists — Hamden, Connecticut, United States
• Advanced Footcare Specialists of Connecticut, LLC — Newtown, Connecticut, United States
• Galli Podiatric Foot and Ankle Associates — New York, New York, United States
• Ankle and Foot Care Centers — Boardman, Ohio, United States
• The Sports Medicine Clinic — Seattle, Washington, United States

Full record on ClinicalTrials.gov

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