NCT03414255

Micronized dHACM Injectable for the Treatment of Achille Tendonitis

A Phase 3, Prospective, Double-Blinded, Randomized Controlled Trial Of The Micronized dHACM Injection As Compared To Saline Placebo Injection In The Treatment Of Achilles Tendonitis

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 146 (actual)
• Sponsor: MiMedx Group, Inc. · Industry
• Sex: All
• Age: 21 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

Prospective, Double-Blinded, Randomized Controlled Trial of the Micronized dHACM Injection as Compared to Saline Placebo Injection in the Treatment of Achilles Tendonitis

Detailed description

Approximately 158 subjects will be enrolled in this study. Each patient will receive 1 injection and be evaluated for efficacy and safety during a 12 month observation period. Randomization will be 1:1. The study is expected to be completed in 24 months, inclusive of enrollment and follow-up of all subjects.

Conditions

• Tendonitis;Achilles

Interventions

Type	Name	Description
BIOLOGICAL	Micronized DHACM	1 mL injection of 40mg Micronized dehydrated human amnion/chorion membrane (DHACM).
DRUG	Saline Injection	Injection of 1mL 0.9% Sodium Chloride Injection, USP

Timeline

• Start date: 2018-01-09
• Primary completion: 2021-03-30
• Completion: 2021-03-30
• First posted: 2018-01-29
• Last updated: 2022-05-19

Locations

14 sites across 1 country: United States

Regulatory

• FDA-regulated drug study