Study Assessing Complete Wound Healing by Comparing Surgenex® PelloGraft in Treating DFU and SanoGraft® in Treating VLU to SOC
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorSurgenex
About this trial
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.
Eligibility criteria
Qualifiers
Subject is at least 18 years of age
Diabetic Foot Ulcer Only - Subject has diagnosed Type 1 or Type 2 diabetes
Subject's wound is located on foot or ankle (DFU) or leg (VLU)
Subject has diabetic foot ulcer > 1.0 cm2 and ≤ 25 cm2 OR venous leg ulcer > 1.0 cm2 and ≤ 50 cm2
Disqualifiers
Subject is pregnant
Subject with diagnosed diabetes has HbA1C > 12 within 3 months Prior to randomization
Subject has > 30% reduction in wound size after 2-week run-in period
Subject has active infection, undrained abscess, or critical colonization of the wound with bacteria
Trial design
Treatments tested in this trial
- PelloGraft
- SanoGraft
Treatment groups
180 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov