NCT01996111

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

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

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 14 (actual)
• Sponsor: MiMedx Group, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
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

Timeline

• Start date: 2013-09-01
• Primary completion: 2014-03-01
• Completion: 2014-04-01
• First posted: 2013-11-27
• Last updated: 2014-06-13

Locations

1 site across 1 country: United States