Status:
RECRUITING
Study Assessing Complete Wound Healing by Comparing Surgenex® PelloGraft in Treating DFU and SanoGraft® in Treating VLU to SOC
Lead Sponsor:
Surgenex
Conditions:
Diabetic Foot Ulcer
Venous Leg Ulcer
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
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 le...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 23 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 9 2026
Estimated Enrollment :
180 Patients enrolled
Trial Details
Trial ID
NCT06515093
Start Date
June 23 2024
End Date
September 9 2026
Last Update
September 23 2025
Active Locations (4)
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1
ILD Research
Vista, California, United States, 92801
2
Future Life Clinical Trials
North Miami, Florida, United States, 33169
3
Boston Medical Center
Boston, Massachusetts, United States, 02118
4
Essential Medical Research
Tulsa, Oklahoma, United States, 74137