The purpose of this study is to compare Pellograft to standard of care modalities in treating diabetic foot ulcers in human subjects, and to compare Sanograft to standard of care in treating venous leg ulcers. The study will demonstrate wound healing outcomes with comparators including time to wound epithelialization, decrease in wound size, and total number of study product applications towards healing outcome. This information is important to the Centers for Medicare and Medicaid Services (CMS) and other payors in determining coverage policy and reimbursement for this product category.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
180
dual layer amnion/chorion-derived allograft
single layer amnion-derived allograft
ILD Research
Vista, California, United States
RECRUITINGTulsa Wound Center
Tulsa, Oklahoma, United States
RECRUITING100% epithelialization
100% epithelialization of wound within 12 weeks (DFU) or 16 weeks (VLU) of initial treatment application. Wound closure is complete with confirmation of 100% epithelialization, no drainage, and no need for additional dressings.
Time frame: 12 weeks (DFU) or 16 weeks (VLU)
Time to Healing
Time to Healing (from initial application of study product to 100% epithelialization of wound)
Time frame: 12 weeks (DFU) or 16 weeks (VLU)
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