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

Last updated: July 22, 2024
Sponsor: Surgenex
Overall Status: Active - Recruiting

Phase

N/A

Condition

Diabetes And Hypertension

Venous Leg Ulcers

Pressure Ulcer

Treatment

SanoGraft

PelloGraft

Clinical Study ID

NCT06515093
24-SUR-001
  • Ages > 18
  • All Genders

Study 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

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 cm2and ≤ 50 cm2

  5. Subject has adequate circulation to affected extremity with TcPO2 results of ≥ 40 mmHg on the dorsum of the affected foot or ABI results ≥ 0.7 and≤ 1.2 or Great ToePressure ≥ 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 legalauthorized representative (LAR)

Exclusion

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 thewound with bacteria

  5. Subject has osteomyelitis or exposed bones, probes to bone or joint capsule oninvestigator's exam or radiographic evidence or bone culture, histology, x-raychanges or MRI

  6. Subject is on parenteral corticosteroids or any cytotoxic agents for 7 consecutivedays during 30 days before screening. Chronic oral steroid use is not excluded ifdose < 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 studycompletion

Study Design

Total Participants: 180
Treatment Group(s): 2
Primary Treatment: SanoGraft
Phase:
Study Start date:
June 23, 2024
Estimated Completion Date:
August 02, 2025

Connect with a study center

  • ILD Research

    Vista, California 92801
    United States

    Active - Recruiting

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.