Diabetic Foot UlcerNCT06515093
Study Assessing Complete Wound Healing by Comparing Surgenex® PelloGraft in Treating DFU and SanoGraft® in Treating VLU to SOC
A study testing PelloGraft and SanoGraft in people with Diabetic Foot Ulcer and Venous Leg Ulcer, run by Surgenex at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetic Foot Ulcer, Venous Leg Ulcer
- What is being tested?
- PelloGraft and SanoGraft
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- 2 sitesUnited States
- Study dates
- 23 Jun 2024to 8 Sep 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subject is at least 18 years of age
- Diabetic Foot Ulcer Only - Subject has diagnosed Type 1 or Type 2 diabetes
- Subject's wound is located on foot or ankle (DFU) or leg (VLU)
- Subject has diabetic foot ulcer > 1.0 cm2 and ≤ 25 cm2 OR venous leg ulcer > 1.0 cm2 and ≤ 50 cm2
- 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
- Subject is willing and able to comply with all protocol requirements
- Subject is willing and able to provide informed consent or obtain consent from legal authorized representative (LAR)
Who cannot join
- Subject is pregnant
- Subject with diagnosed diabetes has HbA1C > 12 within 3 months Prior to randomization
- Subject has > 30% reduction in wound size after 2-week run-in period
- Subject has active infection, undrained abscess, or critical colonization of the wound with bacteria
- Subject has osteomyelitis or joint capsule on investigator's exam or radiographic evidence or bone culture, histology, x-ray changes or MRI
- 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
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- Subject is currently undergoing cancer treatment
- Subject has used biologic skin substitutes within 14 days of enrollment
- Subject has an allergy to suture material
- Subject has life expectancy less than six-months as assessed by the investigator
- Subject is participating in another clinical research study prior to this study completion
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Recruiting
Tulsa Wound Center
Tulsa, Oklahoma, 74135
Lam Le, MD, 918-516-6661, drle@tulsawoundcenter.com
- Recruiting
ILD Research
Vista, California, 92801
Dean Vayser, MD, 858-337-0548, dean@ildresearch.com
About this study
Official title: 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.
- Conditions
- Diabetic Foot Ulcer, Venous Leg Ulcer
- Being tested
- PelloGraft, SanoGraft
- Medical subject headings
- Diabetic Foot, Varicose Ulcer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PelloGraftOther
dual layer amnion/chorion-derived allograft
SanoGraftOther
single layer amnion-derived allograft
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 PelloGraft | Experimental | PelloGraft treatment for diabetic foot ulcers versus Standard of Care treatment for diabetic foot ulcers Receives: Other: PelloGraft |
| Arm 2 SanoGraft | Experimental | SanoGraft treatment for venous leg ulcers vs Standard of Care treatment for venous leg ulcers Receives: Other: SanoGraft |
What is being measured
The primary outcome is the main question the study is designed to answer.
100% epithelialization
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.
Measured: 12 weeks (DFU) or 16 weeks (VLU)
Secondary outcomes (1)
Time to Healing
Time to Healing (from initial application of study product to 100% epithelialization of wound)
Measured: 12 weeks (DFU) or 16 weeks (VLU)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2024
- Study start23 Jun 2024
- Primary completion24 Mar 2027 (estimated)
- Study completion8 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic Foot UlcerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Surgenex
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06515093
- Sponsor's protocol ID
- 24-SUR-001
- Status last verified
- Apr 2026
- First submitted
- 17 Jul 2024
- Last updated
- 7 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06515093
- Acronym / sponsor ID
- 24-SUR-001
- Conditions
- Diabetic Foot Ulcer, Venous Leg Ulcer
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- SurgenexIndustry (pharma, biotech, devices)
- Study start
- 23 Jun 2024 (actual)
- Primary completion
- 24 Mar 2027 (estimated)
- Study completion
- 8 Sep 2027 (estimated)
- First posted
- 23 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm 1 PelloGraft | Experimental | Other: PelloGraftPelloGraft treatment for diabetic foot ulcers versus Standard of Care treatment for diabetic foot ulcers |
| Arm 2 SanoGraft | Experimental | Other: SanoGraftSanoGraft treatment for venous leg ulcers vs Standard of Care treatment for venous leg ulcers |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Subject is at least 18 years of age
- Diabetic Foot Ulcer Only - Subject has diagnosed Type 1 or Type 2 diabetes
- Subject's wound is located on foot or ankle (DFU) or leg (VLU)
- Subject has diabetic foot ulcer > 1.0 cm2 and ≤ 25 cm2 OR venous leg ulcer > 1.0 cm2 and ≤ 50 cm2
- 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
Key exclusion criteria (11 listed)
- Subject is pregnant
- Subject with diagnosed diabetes has HbA1C > 12 within 3 months Prior to randomization
- Subject has > 30% reduction in wound size after 2-week run-in period
- Subject has active infection, undrained abscess, or critical colonization of the wound with bacteria
- Subject has osteomyelitis or joint capsule on investigator's exam or radiographic evidence or bone culture, histology, x-ray changes or MRI
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PelloGraftdual layer amnion/chorion-derived allograft | Other | Arm 1 PelloGraft |
| SanoGraftsingle layer amnion-derived allograft | Other | Arm 2 SanoGraft |
Primary outcome
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.
1 secondary outcome
Time to Healing
Time frame: 12 weeks (DFU) or 16 weeks (VLU)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Apr 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PelloGraft and SanoGraft in people with Diabetic Foot Ulcer and Venous Leg Ulcer, run by Surgenex at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 7 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Pam McKeown (480-404-3143, pamela.mckeown@surgenex.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
100% epithelialization (time frame: 12 weeks (DFU) or 16 weeks (VLU)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Apr 2026.