Ignite Creation Date:
2025-12-25 @ 4:03 AM
Ignite Modification Date:
2026-02-20 @ 6:39 PM
Study NCT ID:
NCT03254602
Status:
COMPLETED
Last Update Posted:
2017-12-07
First Post:
2017-08-14
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Intense Therapeutic Ultrasound for the Treatment of Chronic Plantar Fasciitis
Sponsor:
University Foot and Ankle Foundation
Organization:
Study Overview
Official Title:
Intense Therapeutic Ultrasound for the Treatment of Chronic Plantar Fasciitis Musculoskeletal Pain Reduction
Status:
COMPLETED
Status Verified Date:
2017-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ITU
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 began in August 2016 and was completed in April 2017. The clinical setting: University Foot and Ankle Institute, Santa Monica, California, USA; Single-Blinded, pivotal study for chronic plantar fasciitis.
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 coagulative changes over a small controlled area while leaving the surrounding tissue unaffected. These coagulative changes are known to begin the body's tissue response cascade and promote collagen generation in the targeted anatomy resulting in pain reduction.
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
True
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?: