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Dehydrated Human Amnion/Chorion Membrane Micrografts(dHACM) Injectable in the Treatment of Recalcitrant Plantar Fasciitis

NCT01996111 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 14

Last updated 2014-06-13

No results posted yet for this study

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).

Conditions

  • Plantar Fasciitis

Interventions

PROCEDURE

Injection of 1.0 cc of 0.9% Saline

Injection of 1.0 cc of 0.9% Saline into affected area

PROCEDURE

Injection of 1.0 cc of 10 mg/ml micrograft dHACM suspension

Injection of 1.0 cc of 10 mg/ml micrograft dHACM suspension into affected area

PROCEDURE

Injection of 1.0 cc of 20 mg/ml micrograft dHACM suspension

Injection of 1.0 cc of 20 mg/ml micrograft dHACM suspension into affected area

PROCEDURE

Injection of 1.0 cc of 40 mg/ml micrograft dHACM suspension

Injection of 1.0 cc of 40 mg/ml micrograft dHACM suspension into affected area

Sponsors & Collaborators

  • MiMedx Group, Inc.

    lead INDUSTRY

Principal Investigators

  • Charles M. Zelen, DPM · Professional Education and Research Institute

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
FACTORIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-09-30
Primary Completion
2014-03-31
Completion
2014-04-30

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 NCT01996111 on ClinicalTrials.gov