Study Assessing Complete Wound Healing by Comparing Surgenex® PelloGraft in Treating DFU and SanoGraft® in Treating VLU to SOC

Launched by SURGENEX · Jul 17, 2024

Keywords

ClinConnect Summary

This clinical trial is designed to compare two treatments—Surgenex® PelloGraft for diabetic foot ulcers and SanoGraft® for venous leg ulcers—against standard care practices. The main goal is to see which treatment helps wounds heal faster and more effectively. Researchers will look at how quickly the wounds close up and how much they shrink in size with each treatment. This study is important because it will help determine how these products are covered by insurance.

To participate in the trial, you need to be at least 18 years old and have either Type 1 or Type 2 diabetes with a specific type of wound (either on your foot or leg). Your wound must be a certain size, and you should have good blood flow to the affected area. If you meet these criteria and are willing to follow the study's guidelines, you could be eligible. During the trial, you'll receive the assigned treatment, and the team will monitor your healing progress closely. Remember, this study is focused on finding better ways to help people with these types of wounds heal.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Subject is at least 18 years of age
• • 2. Subject has diagnosed Type 1 or Type 2 diabetes
• • 3. Subject's wound is located on foot or ankle (DFU) or leg (VLU)
• • 4. Subject has diabetic foot ulcer \> 1.0 cm2 and ≤ 25 cm2 OR venous leg ulcer \> 1.0 cm2 and ≤ 50 cm2
• • 5. 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
• • 6. Subject is willing and able to comply with all protocol requirements
• • 7. Subject is willing and able to provide informed consent or obtain consent from legal authorized representative (LAR)
• Exclusion Criteria:
• • 1. Subject is pregnant
• • 2. Subject has HbA1C \> 12 within 3 months Prior to randomization
• • 3. Subject has \> 30% reduction in wound size after 2-week run-in period
• • 4. Subject has active infection, undrained abscess, or critical colonization of the wound with bacteria
• • 5. Subject has osteomyelitis or exposed bones, probes to bone or joint capsule on investigator's exam or radiographic evidence or bone culture, histology, x-ray changes or MRI
• • 6. 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
• • 7. Subject is currently undergoing cancer treatment
• • 8. Subject has used biologic skin substitutes within 14 days of enrollment
• • 9. Subject has an allergy to suture material
• • 10. Subject has life expectancy less than six-months as assessed by the investigator
• • 11. Subject is participating in another clinical research study prior to this study completion