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

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

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

Study contacts

• Study coordinator: Pam McKeown
• Email: pamela.mckeown@surgenex.com
• Phone: 480-404-3143

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Human placental membrane products plus standard care for nonhealing diabetic foot and venous leg ulcers

  This trial will try human placental membrane products together with standard wound care to help adults whose diabetic foot ulcers or venous leg ulcers have not healed.

  Recruiting BioLab Holdings · Philidelphia, Pennsylvania · NCT07364630

• Using human placental membrane wraps with regular wound care to help heal stubborn diabetic foot and venous leg ulcers

  This trial tests whether adding one of four human placental membrane wraps to standard wound care helps people with nonhealing diabetic foot or venous leg ulcers heal faster and more completely than standard care alone.

  Recruiting Phase 4 BioLab Holdings · Philidelphia, Pennsylvania · NCT07089602

• Evaluating new treatments for nonhealing diabetic foot and venous leg ulcers.

  This study is testing whether new treatments for stubborn diabetic foot and leg ulcers can help people heal better when combined with standard care compared to just standard care alone.

  Recruiting Phase 4 Tiger Biosciences, LLC. · Monroeville, Pennsylvania · NCT06826339

• Evaluating new treatments for diabetic foot and venous leg ulcers

  This study is testing different new treatments for stubborn diabetic foot and leg ulcers to see if they help heal better than the standard care alone.

  Recruiting Stability Biologics · Circleville, Ohio · NCT06560502

• Observing the use of amnion/chorion membrane for chronic wounds

  This study is testing if a new treatment using a special membrane can help people with stubborn diabetic foot ulcers and venous leg ulcers heal better than with standard care.

  Recruiting at 5 sites MiMedx Group, Inc. · Kobe, Hyōgo and 4 other locations · NCT06236750

• Tracking the healing of chronic wounds with a special dressing

  This study is testing a special dressing called Mepilex Up to see if it helps people with chronic wounds, like venous leg ulcers and diabetic foot ulcers, heal better over six weeks.

  Recruiting at 4 sites Molnlycke Health Care AB · Castro Valley, California and 3 other locations · NCT05588583

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.