A Multicenter, Prospective, Randomized Controlled Comparative Parallel Study To determine the safety and effectiveness of EpiCord as compared to standard of care (SOC) therapy for the treatment of chronic, non-healing diabetic foot ulcers (DFUs)
This is a prospective, multicenter, randomized controlled trial. The trial will include approximately 66 subjects in up to 10 experienced clinical centers in the United States. The estimated enrollment period is 18 weeks (this includes the 2-week run-in period). After completing a 2-week screening period, the subjects will be followed for at least 16 weeks post-randomization.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
130
Weekly application of EpiCord and standard of care (moist wound therapy and offloading)
moist wound therapy and offloading
Central Research Associates
Birmingham, Alabama, United States
Arizona Regional Medical Research (ARMR)
Tucson, Arizona, United States
ILD Research
Carlsbad, California, United States
Complete Ulcer Closure
The percentage of subjects with complete closure of the study ulcer as assessed by photographic evaluation
Time frame: 12 weeks
Study Safety Measurement
The proportion of product related Adverse Events (AEs), Serious Adverse Events (SAEs), and Unanticipated Adverse Events at 12 weeks.
Time frame: 12 weeks
Time to complete closure
As assessed by photographic evaluation and the Investigator
Time frame: up to 12 weeks
Rate of wound closure
As assessed by photographic evaluation and the Investigator
Time frame: up to 12 weeks
Incidence of ulcer recurrence
Incidence of ulcer recurrence at the site of the study ulcer
Time frame: up to 12 weeks
Quality of Life Health Survey
Change in quality of life metrics as measured by SF-36 Health Survey
Time frame: up to 12 weeks
Quality of Life-Pain
Change in quality of life metrics as measured by changes in the patients reported pain scores as measure by the Visual Analog Scale
Time frame: up to 12 weeks
Cost effectiveness of treatment
Cost effectiveness of treatment regime. looking at the number of grafts used on each study subject throughout the study.
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Limb Preservation Platform, Inc
Fresno, California, United States
Foot and ankle clinic
Los Angeles, California, United States
Doctors Research Network
Miami, Florida, United States
Joseph M. Still Burn Center at Doctors Hospital
Augusta, Georgia, United States
Ochsner Clinic Foundation
New Orleans, Louisiana, United States
Advanced Foot & Ankle Center
Las Vegas, Nevada, United States
Foot and Ankle Center
Haverford, Pennsylvania, United States
...and 3 more locations
Time frame: up to 12 weeks