New skin grafts aim to heal stubborn ulcers faster

NCT ID NCT06515093

Disease control Sponsor: Surgenex Source: ClinicalTrials.gov ↗

First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study compares two types of skin grafts (PelloGraft and SanoGraft) to standard wound care for healing diabetic foot ulcers and venous leg ulcers. About 180 adults with chronic wounds will be enrolled. The goal is to see if these grafts help wounds close completely within 12 to 16 weeks.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance: PelloGraft (dual layer amnion/chorion allograft) and SanoGraft (single layer amnion allograft)
What this could lead to: If successful, these grafts could become a standard treatment to help diabetic foot and venous leg ulcers heal faster and more completely.
What could go wrong: This is a post-market study, not a large Phase 3 trial. Results may not apply to all patients, and some ulcers may not heal despite treatment.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 180 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jun 2024

Expected to finish

Sep 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

Diabetic Foot ulcer of lower limbs Varicose Ulcer

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Diabetic foot ulcer Venous leg ulcer

How to take part

Only the study team decides who joins. These are the ways to reach them.

The places running it

2 sites. The list below names each one and where it is.
The official record

ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

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A doctor treating you

A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

New skin grafts aim to heal stubborn ulcers faster

What the study statuses mean