Comparing PelloGraft and SanoGraft for treating diabetic foot and venous leg ulcers

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

This study is testing whether PelloGraft can help heal diabetic foot ulcers and SanoGraft can help heal venous leg ulcers better than standard care.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 180 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Surgenex (Industry-sponsored)
• Drugs / interventions: prednisone
• Locations: 2 sites (Vista, California and 1 other locations)
• Trial ID: NCT06515093 on ClinicalTrials.gov

What this trial studies

This study aims to evaluate the effectiveness of PelloGraft in treating diabetic foot ulcers and SanoGraft in treating venous leg ulcers compared to standard care. It will measure wound healing outcomes such as time to epithelialization, reduction in wound size, and the number of applications needed for healing. The findings will provide valuable data for healthcare payors, including the Centers for Medicare and Medicaid Services, regarding coverage and reimbursement policies for these treatments.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18 and older with diagnosed Type 1 or Type 2 diabetes and specific ulcer characteristics.

Not a fit: Patients who are pregnant, have uncontrolled diabetes, or active infections may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved healing outcomes for patients with diabetic foot ulcers and venous leg ulcers.

How similar studies have performed: Other studies have shown promise in using similar grafts for wound healing, suggesting potential for success in this approach.

Eligibility criteria

Inclusion Criteria:

1. Subject is at least 18 years of age
2. Diabetic Foot Ulcer Only - 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 with diagnosed diabetes 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 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

Where this trial is running

Vista, California and 1 other locations

• ILD Research — Vista, California, United States (Recruiting)
• Tulsa Wound Center — Tulsa, Oklahoma, United States (Recruiting)

Study contacts

• Study coordinator: Pam McKeown

Conditions Diabetic Foot Ulcer; Venous Leg Ulcer