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

April 1, 2026 updated by: Surgenex

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

180

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • California
      • Vista, California, United States, 92801
        • Recruiting
        • ILD Research
        • Contact:
    • Oklahoma
      • Tulsa, Oklahoma, United States, 74135

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Arm 1 PelloGraft
PelloGraft treatment for diabetic foot ulcers versus Standard of Care treatment for diabetic foot ulcers
Other: PelloGraft
dual layer amnion/chorion-derived allograft
Experimental: Arm 2 SanoGraft
SanoGraft treatment for venous leg ulcers vs Standard of Care treatment for venous leg ulcers
Other: SanoGraft
single layer amnion-derived allograft

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
100% epithelialization
Time Frame: 12 weeks (DFU) or 16 weeks (VLU)
100% epithelialization of wound within 12 weeks (DFU) or 16 weeks (VLU) of initial treatment application. Wound closure is complete with confirmation of 100% epithelialization, no drainage, and no need for additional dressings.
12 weeks (DFU) or 16 weeks (VLU)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time to Healing
Time Frame: 12 weeks (DFU) or 16 weeks (VLU)
Time to Healing (from initial application of study product to 100% epithelialization of wound)
12 weeks (DFU) or 16 weeks (VLU)

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Quality of Life via subject questionnaire
Time Frame: 2-weeks post wound closure
Qualify of Life at 2-week post closure follow-up via SF-36 Questionnaire
2-weeks post wound closure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Surgenex

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 23, 2024

Primary Completion (Estimated)

March 24, 2027

Study Completion (Estimated)

September 8, 2027

Study Registration Dates

First Submitted

July 17, 2024

First Submitted That Met QC Criteria

July 17, 2024

First Posted (Actual)

July 23, 2024

Study Record Updates

Last Update Posted (Actual)

April 7, 2026

Last Update Submitted That Met QC Criteria

April 1, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 24-SUR-001

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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