Clinical Evaluation of Placement of Radiofrequency-based Plasma Microdebridement in the Treatment Algorithm for Foot and Ankle Tendinosis and Plantar Fasciosis

Withdrawn before enrolling · Phase 4

Conditions studied: Plantar Fasciosis, Achilles Tendinosis

In brief

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 standard of care treatment. Standard of care will include traditional conservative care measures, ESWT, radiofrequency-based plasma microdebridement, scalpel debridement and/or surgical release.

Key facts

Study ID

NCT00420875

Run by

ArthroCare Corporation

People needed

0

Starts

2007-06-01

Last updated by the study team

2015-08-26

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Foot Care Physicians — Mesa, Arizona, United States
• Foot and Ankle Institute of Santa Monica — Santa Monica, California, United States
• Foot and Ankle Clinic of Oakwood — Oakwood, Georgia, United States

Full record on ClinicalTrials.gov

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