Actively Recruiting
Study Assessing Complete Wound Healing by Comparing Surgenex® PelloGraft in Treating DFU and SanoGraft® in Treating VLU to SOC
Led by Surgenex · Updated on 2026-04-07
180
Participants Needed
2
Research Sites
167 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Study Assessing Complete Wound Healing by Comparing Surgenex® PelloGraft in Treating DFU and SanoGraft® in Treating VLU to SOC
Who Can Participate
Eligibility Criteria
You may qualify if you...
- At least 18 years old
- Diagnosed with Type 1 or Type 2 diabetes for diabetic foot ulcer group
- Wound located on the foot or ankle for diabetic foot ulcers, or on the leg for venous leg ulcers
- Diabetic foot ulcer size greater than 1.0 cm2 and less than or equal to 25 cm2, or venous leg ulcer size greater than 1.0 cm2 and less than or equal to 50 cm2
- Adequate circulation to the affected limb confirmed by TcPO2 240 mm Hg on the top of the foot, or ABI between 0.7 and 1.2, or Great Toe Pressure 250 mmHg
- Willing and able to follow all study requirements
- Able to give informed consent or have a legal representative provide consent
You will not qualify if you...
- Pregnant
- For diabetic patients, HbA1C greater than 12 within 3 months before randomization
- More than 30% wound size reduction after a 2-week run-in period
- Active infection, undrained abscess, or critical bacterial colonization in the wound
- Presence of osteomyelitis or joint capsule infection confirmed by exam or imaging
- Use of parenteral corticosteroids or cytotoxic agents for 7 consecutive days in the 30 days before screening; chronic oral steroid use allowed if prednisone dose is less than 10 mg per day
- Currently receiving cancer treatment
- Used biologic skin substitutes within 14 days before enrollment
- Allergy to suture material
- Life expectancy less than six months as assessed by the investigator
- Participating in another clinical research study before this study is completed
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 2 locations
1
ILD Research
Vista, California, United States, 92801
Actively Recruiting
2
Tulsa Wound Center
Tulsa, Oklahoma, United States, 74135
Actively Recruiting
Research Team
P
Pam McKeown
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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