Status:
WITHDRAWN
Clinical Evaluation of Placement of Radiofrequency-based Plasma Microdebridement in the Treatment Algorithm for Foot and Ankle Tendinosis and Plantar Fasciosis
Lead Sponsor:
ArthroCare Corporation
Conditions:
Plantar Fasciosis, Achilles Tendinosis
Eligibility:
All Genders
18-65 years
Phase:
PHASE4
Brief Summary
To determine the magnitude of improvement for pain and function symptoms over a two year period after enrollment into the registry study in patients presenting with chronic heel pain and receiving sta...
Detailed Description
Several million Americans receive treatment for heel pain each year, with more than two million patients treated each year for plantar fasciitis and fasciosis alone.(2) Conservative treatment options ...
Eligibility Criteria
Inclusion
- Subject is at least 18 years of age
- Subject's history and physical examination pinpoints anatomic origin of heel pain as associated with plantar fasciosis (tenderness with palpation and local pressure over the medial calcaneal tuberosity on passive dorsiflexion) or Achilles tendinosis (tenderness upon palpation and local pressure at the insertion site)
- Subject (or guardian) must sign IRB approved informed consent form
- Subject is willing and able to complete required follow-up
Exclusion
- Previous fascia surgery on pathology to be treated by this study
- Multiple anatomic origins of heel pain in foot to be treated by study
- History or documentation showing Type I and Type II Diabetes Mellitus
- Physical findings and documentation of coagulopathy, infection, tumor or other systemic disease(s)
- History or documentation showing peripheral vascular disease or autoimmune disease
- History or documentation of fibromyalgia
- Subject is currently participating in another drug/device study related to the injured plantar fascia or Achilles tendon
- Pregnant or pregnant suspected subjects prior to treatment
- Subject is incapable of understanding or responding to the study questionnaires
Key Trial Info
Start Date :
June 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00420875
Start Date
June 1 2007
Last Update
August 26 2015
Active Locations (3)
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1
Foot Care Physicians
Mesa, Arizona, United States, 85204
2
Foot and Ankle Institute of Santa Monica
Santa Monica, California, United States, 90403
3
Foot and Ankle Clinic of Oakwood
Oakwood, Georgia, United States, 30566