Micronized dHACM Injectable for the Treatment of Achille Tendonitis
- Conditions
- Tendonitis;Achilles
- Interventions
- Biological: Micronized DHACMDrug: Saline Injection
- Registration Number
- NCT03414255
- Lead Sponsor
- MiMedx Group, Inc.
- Brief 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 146
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Micronized DHACM Micronized DHACM 1mL injection of 40mg Micronized dehydrated human amnion/chorion membrane (DHACM) Saline Injection Saline Injection Injection of 1mL 0.9% Sodium Chloride Injection, USP
- Primary Outcome Measures
Name Time Method Incidence of adverse events 365 days The incidence of related Adverse Events (AEs), Serious Adverse Events (SAEs), and Unanticipated Adverse Events during the first 12 months post injection
Change in VAS score 90 days Visual Analog Scale, Left end point is "No Pain". Right end point is "worst pain imaginable"
- Secondary Outcome Measures
Name Time Method Foot Function Index Revised (FFI-R) (Short Form) 90 days Subjects circle the number that correlates how bad their foot pain was in certain situation.
Trial Locations
- Locations (14)
Coastal Podiatry, Inc.
🇺🇸Virginia Beach, Virginia, United States
Doctors Research Network
🇺🇸Miami, Florida, United States
Futuro Clinical Trials
🇺🇸McAllen, Texas, United States
Foot and Ankle Clinic
🇺🇸Los Angeles, California, United States
Five Cities Foot Clinic
🇺🇸Pismo Beach, California, United States
South Florida Veterans Affairs
🇺🇸Miami, Florida, United States
West Penn Hospital
🇺🇸Pittsburgh, Pennsylvania, United States
Advanced Foot & Ankle Center
🇺🇸Las Vegas, Nevada, United States
University Orthopedics Center
🇺🇸Altoona, Pennsylvania, United States
ILD Research Center
🇺🇸Carlsbad, California, United States
Central Research Associates
🇺🇸Birmingham, Alabama, United States
Northside Podiatry
🇺🇸Buford, Georgia, United States
Foot and Ankle Center of Illinois
🇺🇸Springfield, Illinois, United States
Southern Arizona VA Health Care System
🇺🇸Tucson, Arizona, United States