Ignite Creation Date:
2025-12-24 @ 5:31 PM
Ignite Modification Date:
2026-01-02 @ 1:05 AM
Study NCT ID:
NCT03414268
Status:
COMPLETED
Last Update Posted:
2022-05-19
First Post:
2018-01-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Micronized dHACM Injectable for the Treatment of Plantar Fasciitis
Sponsor:
MiMedx Group, Inc.
Organization:
Study Overview
Official Title:
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
Status Verified Date:
2020-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: