The purpose of this clinical evaluation is to collect patient outcome data on a commercially available 510K FDA cleared advanced skin substitute. The commercially available product is Helicoll® Advanced Skin Substitute. In this trial two groups of subjects with Wagner 1 diabetic foot ulcers (DFUs), will receive standard of care (SOC) treatment for their condition. Half of the patients will have their SOC treatment with Epifix® or Grafix® and the other half will receive a 510K FDA cleared Helicoll® Advanced Skin Substitute as the primary treatment. The primary endpoint is the percentage wound area reduction of the target ulcer. Secondary endpoints include the proportion of subjects that obtain complete closure over the 5-week treatment period, the time to achieve complete wound closure of the target ulcer by the end of 5 weeks, and mean number of IP applications.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
24
SOC primary dressing with Helicoll®
SOC primary dressing with Epifix® or Grafix®
Clemente Clinical Research
Los Angeles, California, United States
Doctors Research Network
South Miami, Florida, United States
Foot and Ankle Specialists of the Mid-Atlantic
Salem, Virginia, United States
Percentage of Wound Area Reduction
Average Percentage of Wound Area Reduction from Treatment Visit 1 to Treatment Visit 4 measured manually with digital photography
Time frame: 4 weeks
Number of Participants With Repeated Applications
Number of Participants with repeated applications of the Advanced Skin Substitute used to obtain wound closure
Time frame: 4 weeks
Proportion of Complete Closure
The proportion of subjects that obtain complete closure over the 5-week treatment period
Time frame: 5 weeks
Time to Achieve Complete Wound Closure
The time to achieve complete wound closure of the target ulcer by the end of 5 weeks
Time frame: 5 weeks
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