A Prospective, Randomized, Controlled, Blinded, Comparative Study of Dehydrated Human Amnion/Chorion Membrane Micrografts(dHACM) Injectable in the Treatment of Recalcitrant Plantar Fasciitis

MiMedx Group, Inc.1 site in 1 country14 target enrollmentSeptember 2013

ConditionsPlantar Fasciitis

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Plantar Fasciitis
Sponsor: MiMedx Group, Inc.
Enrollment: 14
Locations: 1
Primary Endpoint: Reduction of inflammation as measured by AOFAS Hindfoot scores
Status: Terminated
Last Updated: 11 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

This is a prospective, controlled, randomized, blinded and comparative, single-center clinical trial comparing the improvement of patients with recalcitrant plantar fasciitis symptoms that have received standard of care versus treatment with differing amounts of injectable dehydrated human amnion/chorion membrane micrografts(dHACM).

Registry

clinicaltrials.gov

Start Date

September 2013

End Date

April 2014

Last Updated

11 years ago

Study Type

Interventional

Study Design

Factorial

Sex

All

Investigators

Sponsor

MiMedx Group, Inc.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•At least 18 years old.
•Both male and female patients will be selected.
•Plantar fasciitis has been treated with conservative usual care for at least 8 weeks, including at least three of the following modalities
•Rest, Ice, Compression, Elevation (RICE)
•Corticosteroid injection
•Stretching exercises
•Non-steroidal Anti-Inflammatory Drugs (NSAIDs)
•Orthotics
•Females of childbearing potential must be willing to use acceptable methods of contraception (birth control pills, barriers, or abstinence).
•Patient understands and is willing to participate in the clinical study and can comply with weekly visits and the follow-up regimen.

Exclusion Criteria

Not provided

Outcomes

Primary Outcomes

Reduction of inflammation as measured by AOFAS Hindfoot scores

Time Frame: 8 Weeks

The primary objective of this study is to compare the efficacy of the different treatment amounts in reduction of inflammation as measured by AOFAS Hindfoot scores.