Clinical trial NCT06515093: Study Assessing Complete Wound Healing by Comparing Surgenex® PelloGraft in Treating DFU and SanoGraft® in Treating VLU to SOC
Official title: A Randomized Post-Market Study Assessing Complete Wound Healing by Comparing Surgenex® PelloGraft in Treating Diabetic Foot Ulcers (DFU) and SanoGraft® in Treating Venous Leg Ulcers (VLU) to SOC Treatment
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Diabetic Foot Ulcer
Venous Leg Ulcer
Lead sponsor: Surgenex
Sponsor class: INDUSTRY
First posted: 2024-07-23
Enrollment: 180
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 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: 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

Primary outcomes:
measure: 100% epithelialization
timeFrame: 12 weeks (DFU) or 16 weeks (VLU)
Secondary outcomes:
measure: Time to Healing
timeFrame: 12 weeks (DFU) or 16 weeks (VLU)
Other outcomes:
measure: Quality of Life via subject questionnaire
timeFrame: 2-weeks post wound closure
Locations:
city: Vista
country: United States
facility: ILD Research
state: California
Study officials:
References: