ActiPatch Plantar Fasciitis Clinical Trial | NCT01431066

Studies
ActiPatch Plantar Fasciitis Clinical Trial

NCT01431066

Sponsor

University of British Columbia

Status

Completed

Last Update Posted

Mar 3, 2014Estimated

Enrollment

28Actual

Phase

Phase 3

Conditions

Plantar Fasciitis
Plantar Fasciopathy

Interventions

Sham pulsed radio-frequency electromagnetic device
ActiPatch PRFE Device

Countries

Canada

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2011

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 2011

Primary Completion Date

Jul 2013Actual

Completion Date

Jul 2013Actual

First Submitted Date

Sep 7, 2011

First Submission Date that Met QC Criteria

Sep 7, 2011

First Posted Date

Sep 9, 2011Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 27, 2014

Last Update Posted Date

Mar 3, 2014Estimated

Name	Class
BioElectronics Corporation	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Plantar fasciopathy is a chronic condition affecting both sedentary populations, individuals in the workplace who must stand for prolonged periods of time, and athletes. It can be disabling. There is no single accepted treatment course that is recommended in the literature.

The use of pulsed radio-frequency electromagnetic (PRFE) devices has been proposed as a treatment option in chronic soft-tissue injury due to its ability to reduce pain and inflammation.

The proposed study will investigate the efficacy of the use of a PRFE device for the treatment of chronic heel pain using a double blind randomized placebo controlled design study.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

28Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Control	Placebo Comparator	Sham device that resembles the Actipatch PRFE device, including the light that illuminates when active, but the transmitting function has been disabled.	Device: Sham pulsed radio-frequency electromagnetic device
Actipatch	Experimental	Use of the Actipatch PRFE device that is integrated into a viscoelastic heel pad for the treatment of plantar fasciopathy	Device: ActiPatch PRFE Device

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Sham pulsed radio-frequency electromagnetic device	Device	Disabled PRFE device	Control

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Visual Analog Scale (VAS) for pain		4 Weeks Follow-up

Secondary Outcomes

Measure	Description	Time Frame
Visual analog scale for pain		26 weeks
Foot and ankle disability index		26 weeks
Tegner activity scale

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

All patients with diagnosis of plantar fasciitis agreeing to participate
Over 18 years old
Able to wear unit and keep data up-to-date records of use
Agree to forgo additional treatments during the study period

Exclusion Criteria:

Patients who have refused, are unable to give or have withdrawn consent
Patients with heel pain present less than 3 months

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Division of Sports Medicine		Vancouver	British Columbia	V6T 1Z3	Canada

Condition Browse Module

MeSH Terms

ID	Term
D036981	Fasciitis, Plantar

Ancestor Terms

ID	Term
D005208	Fasciitis
D009140	Musculoskeletal Diseases
D005534	Foot Diseases

Browse Leaves

Not provided

Browse Branches

Not provided