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Micronized dHACM Injectable for the Treatment of Achille Tendonitis

NCT03414255 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 146

Last updated 2022-05-19

No results posted yet for this study

Summary

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

Conditions

  • Tendonitis;Achilles

Interventions

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

Sponsors & Collaborators

  • MiMedx Group, Inc.

    lead INDUSTRY

Principal Investigators

  • Stuart D Miller, MD · MedStar Union Memorial Hospital Baltimore, MD

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
21 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-01-09
Primary Completion
2021-03-30
Completion
2021-03-30
FDA Drug
Yes

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 NCT03414255 on ClinicalTrials.gov