NCT06515093 · Surgenex
Study Assessing Complete Wound Healing by Comparing Surgenex® PelloGraft in Treating DFU and SanoGraft® in Treating VLU to SOC
What this study is about
The purpose of this study is to compare Pellograft to the usual treatment modalities in treating diabetic foot ulcers in human subjects, and to compare Sanograft to the usual treatment in treating venous leg ulcers.
View original scientific description
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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
- Subject has adequate circulation to affected extremity with TcPO2 results of ≥ 40 mm Hg on the dorsum of the affected foot or ABI results ≥ 0.7 and≤ 1.2 or Great Toe Pressure ≥ 50 mmHg
- Subject is willing and able to comply with all protocol requirements
- Subject is willing and able to provide informed consent or obtain consent from legal authorized representative (LAR)
Exclusion criteria
- 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
- Subject has osteomyelitis or joint capsule on investigator's exam or radiographic evidence or bone culture, histology, x-ray changes or MRI
- Subject is on parenteral corticosteroids or any cytotoxic agents for 7 consecutive days during 30 days before screening. Chronic oral steroid use is not excluded if dose \< 10 mg per day of prednisone
- Subject is currently undergoing cancer treatment
- Subject has used biologic skin substitutes within 14 days of enrollment
- Subject has an allergy to suture material
- Subject has life expectancy less than six-months as assessed by the investigator
- Subject is participating in another clinical research study prior to this study completion
Where
- Vista, California
- Tulsa, Oklahoma
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Apr 7, 2026 · Source of record for eligibility and locations