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Micronized dHACM Injectable for the Treatment of Plantar Fasciitis

NCT02427191 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 147

Last updated 2020-11-17

No results posted yet for this study

Summary

Prospective, single-blinded, randomized controlled trial of the micronized dHACM injection as compared to the saline placebo injection in the treatment of plantar fasciitis

Conditions

  • Fasciitis, Plantar

Interventions

OTHER

AmnioFix® Injectable

1 mL injection of 40 mg Micronized dehydrated human amnion/chorion membrane (dHACM)

DRUG

Saline Injection

Injection of 1mL 0.9% Sodium Chloride Injection, USP

Sponsors & Collaborators

  • MiMedx Group, Inc.

    lead INDUSTRY

Principal Investigators

  • Stuart D Miller, MD · MedStar Union Memorial Hospital, Baltimore, MD

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
21 Years
Max Age
79 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-03-31
Primary Completion
2018-08-31
Completion
2018-08-31
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02427191 on ClinicalTrials.gov