Status:
COMPLETED
Intense Therapeutic Ultrasound for the Treatment of Chronic Plantar Fasciitis
Lead Sponsor:
University Foot and Ankle Foundation
Collaborating Sponsors:
Guided Therapy Systems
Conditions:
Plantar Fasciitis, Chronic
Eligibility:
All Genders
18-85 years
Phase:
NA
Brief Summary
A clinical trial evaluating the effectiveness, safety and patient tolerance for the use of Intense Therapeutic Ultrasound (ITU) for chronic, Plantar Fasciitis musculoskeletal tissue pain reduction beg...
Detailed Description
Intense Therapeutic Ultrasound (ITU) is an established ultrasound based therapy in which sound waves are concentrated and focused into selected musculoskeletal tissue, to produce selective thermal coa...
Eligibility Criteria
Inclusion
- Chronic Pain (\>90 days) from previously diagnosed Plantar Fasciitis, where "Standard of Care" regimens failed to relief pain in the affected anatomy.
- No History of surgery to the affected anatomy.
- No alternative treatment procedures within the last 90 days.
- Age: 18 - 85, depending on the study.
- Unilateral Pain
- Willingness to complete treatment and post treatment regimen as described.
- Patients who have provided written and verbal informed consent.
Exclusion
- Patients currently enrolled in any other non-conservative, device, or Investigational New Drug clinical trial, or who have participated in a clinical study involving the Plantar Fascia, thirty days prior to study initiation;
- Patients who have participated in any other clinical study involving an investigational product 30 days prior to enrollment that, in the opinion of the Principal Investigator, could affect the outcome of this study;
- Patients who have received previous treatment in the symptomatic limb (not including conservative treatment);
- At the Principal Investigator's discretion, any patient that should be excluded based on their current condition or medical history.
Key Trial Info
Start Date :
August 4 2016
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 10 2017
Estimated Enrollment :
33 Patients enrolled
Trial Details
Trial ID
NCT03254602
Start Date
August 4 2016
End Date
April 10 2017
Last Update
December 7 2017
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