NCT03414268

Micronized dHACM Injectable for the Treatment of Plantar Fasciitis

A Phase 3, Prospective, Double-Blinded, Randomized Controlled Trial of the Micronized dHACM Injection As Compared To Saline Placebo Injection In The Treatment Of Plantar Fasciitis

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 208 (actual)
• Sponsor: MiMedx Group, Inc. · Industry
• Sex: All
• Age: 21 Years – 79 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed description

Approximately 276 patients will be enrolled in this study. Each patient will receive 1 injection and be evaluated for efficacy and safety during a 6-month observation period. Randomization will be 1:1. The study is expected to be completed within 34 months, inclusive of enrollment and follow-up of all subjects.

Conditions

• Fasciitis, Plantar

Interventions

Type	Name	Description
OTHER	Micronized dHACM	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

Timeline

• Start date: 2018-01-08
• Primary completion: 2021-03-17
• Completion: 2021-03-17
• First posted: 2018-01-29
• Last updated: 2022-05-19

Locations

17 sites across 1 country: United States

Regulatory

• FDA-regulated drug study