Diabetic Foot Ulcer (DFU)Phase 4NCT07209475
Effect of Amnio-Maxx on the Healing Rate of Chronic Diabetic Foot Ulcers.
A Phase 4 study testing Amnio-Maxx® Dual Layer Amnion Patch in people with Diabetic Foot Ulcer (DFU) and Amnio-Maxx, run by Royal Biologics at 8 sites in United States.
Trial summary
This study will evaluate a cellular, acellular, matrix-like product (CAMP) and Standard of Care (SOC) versus SOC alone in the closure of nonhealing diabetic foot ulcers (DFUs). The study will evaluate Amnio-Maxx® Dual Layer Amnion Patch. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetic Foot Ulcer (DFU), Amnio-Maxx
- What is being tested?
- Amnio-Maxx® Dual Layer Amnion Patch
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 248 participants
- Where
- 8 sitesUnited States
- Study dates
- 14 Aug 2025to 14 Aug 2026
- Phase
- Phase 4
- 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
- Potential subjects are required to meet all the following criteria for enrollment into the study and subsequent randomization.
- The potential subject is 18 years of age or older. At least 50% of the enrolled population must be > 65 years of age.
- The potential subject has a history of Type I or Type II Diabetes Mellitus requiring treatment by a physician with either oral medications and/or insulin replacement therapy.
- Potential subjects have an ulcer characterized by the following:
- Presence of a diabetic foot ulcer Wagner 1 or 2 grade at the first screening visit on any aspect of the foot, provided it is at or below the aspect of the medial malleolus. [NOTE: If two or more DFUs are present with the same grade, the index ulcer is the largest ulcer and the only one evaluated in the study. Index ulcer must be more than 5 cm distant apart.]
- A diabetic foot ulcer present for greater than 4 weeks (documented in the medical record) but less than 12 months duration if being treated with active SOC.
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- Objectively, less than 20% healing in the two-week screening period prior to randomization.
- Study ulcer is a minimum of 1.0cm2 and a maximum of 25 cm2 post-debridement at first treatment visit.
- Index ulcer and/or index ulcer limb may have had prior infection, but infection(s) must be adequately treated and controlled as defined by IDSA Guidelines Grade level 1
- The subject is able and willing to follow the protocol requirements.
- Subject has signed informed consent. Adequate circulation to the affected foot as demonstrated by a dorsum transcutaneous oxygen measurement (TCOM) or a skin perfusion pressure (SPP) measurement of ≥ 30 mmHg; an ABI between 0.7 and ≤ 1.3, or TBI of >6 within 3 months of the first Screening Visit.
- 10. Negative pregnancy test for females of childbearing potential (e.g., not post- menopausal for at least one year or surgically sterile). Females of childbearing potential must be willing to use acceptable methods of contraception (birth control methods, barriers, or abstinence) starting at Screening and continuing through the duration of their study participation.
- 11. The index ulcer has been offloaded with protocol defined offloading device throughout the study run-in period for at least 14 days prior to randomization (Run-in period defined as Screening through TV1/Randomization).
- 12. The index ulcer has a clean base and is free of necrotic debris at time of placement of treatment product.
Who cannot join
- The Subject has a known life expectancy of < 1 year.
- Index ulcer has been present for >1 year.
- Patient does not have adequate 2-week historical data demonstrating < 20% area reduction.
- Subject is unable to comply with offloading device.
- Presence of any condition(s) which seriously compromises the subject's ability to complete this study or has a known history of poor adherence to medical treatment.
- Subject has ulcers that are completely necrotic or fibrotic tissue
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- Subject has major uncontrolled medical disorders such as serious cardiovascular, renal, liver or pulmonary disease, lupus, palliative care or sickle cell anemia.
- Subject currently being treated for an active malignant disease
- or subjects with history of malignancy within the ulcer.
- The Subject has other concurrent conditions that in the opinion of the Principal Investigator may compromise subject safety.
- Known contraindications to amniotic tissue membranes or known allergies to any of the Amnio-Maxx components.
- Concurrent participation in another clinical trial that involves an investigational drug or device that would interfere with this study.
- Index ulcer has reduced in area by 20% or more after 2 weeks of standard of care from the first screening visit (S1) to the TV1/randomization visit.
- Subject is pregnant or breastfeeding.
- Subjects with a history of more than two weeks treatment with immunosuppressants (including systemic corticosteroids
- >10mg daily dose), cytotoxic chemotherapy, or application of topical steroids to the ulcer surface within 30 days prior to randomization visit or who receive such medications during the screening period, or who are anticipated to require such medications during the course of the study.
- Index ulcer has been previously treated with tissue engineered materials (e.g. Apligraf® or Dermagraft®) or other scaffold materials (e.g. Oasis, Matristem) within the last 30 days preceding the first treatment visit.
- -
Trial locations and contacts
8 sites in 1 country. Contact the study team or a site near you to ask about taking part.
8 sites in 1 country
United States8 sites, 8 recruiting
- Recruiting
Lion Heart Clinical Research
Burbank, California, 91501
Nicole Schrecngost, 7246643843, nschrecengost@serenagroups.com
Greg Cosentino, greg.cosentino@royalbiologics.com
- Recruiting
VAST Clinical Research Carrollton Foot Center
Carrollton, Texas, 75010
Nicole Schrecngost, 7246643843, nschrecengost@serenagroups.com
Greg Cosentino, greg.cosentino@royalbiologics.com
- Recruiting
Suffolk Foot and Ankle
East Patchogue, New York, 11772
Nicole Schrecngost, 7246643843, nschrecengost@serenagroups.com
Greg Cosentino, greg.cosentino@royalbiologics.com
- Recruiting
Royal Research South
Miami, Florida, 33150
Nicole Schrecngost, 7246643843, nschrecengost@serenagroups.com
Greg Cosentino, greg.cosentino@royalbiologics.com
- Recruiting
SerenaGroup Research Center
Omaha, Nebraska, 68114
Nicole Schrecngost, 7246643843, nschrecengost@serenagroups.com
Greg Cosentino, greg.cosentino@royalbiologics.com
- Recruiting
Elite Foot & Ankle Associates
Spicewood, Texas, 78669
Nicole Schrecngost, 7246643843, nschrecengost@serenagroups.com
Greg Cosentino, greg.cosentino@royalbiologics.com
- Recruiting
Denali Health Atlanta, LLC
Stone Mountain, Georgia, 30083
Nicole Schrecngost, 7246643843, nschrecengost@serenagroups.com
Greg Cosentino, greg.cosentino@royalbiologics.com
- Recruiting
Wound Care of Tulsa
Tulsa, Oklahoma, 74135
Nicole Schrecngost, 7246643843, nschrecengost@serenagroups.com
Greg Cosentino, greg.cosentino@royalbiologics.com
About this study
Official title: A Randomized Controlled Multicenter Trial, Examining the Effect of Amnio-Maxx on the Healing Rate of Chronic Diabetic Foot Ulcers.
This study will evaluate a cellular, acellular, matrix-like product (CAMP) and Standard of Care (SOC) versus SOC alone in the closure of nonhealing diabetic foot ulcers (DFUs). The study will evaluate Amnio-Maxx® Dual Layer Amnion Patch.
- Conditions
- Diabetic Foot Ulcer (DFU), Amnio-Maxx
- Being tested
- Amnio-Maxx® Dual Layer Amnion Patch, Standard of Care (Investigator Choice)
- Medical subject headings
- Diabetic Foot
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Amnio-Maxx® Dual Layer Amnion PatchBiological
Application of Amnio-Maxx® Dual Layer Amnion Patch
Standard of Care (Investigator Choice)Other
Cleansing, debridement, wound documentation, off-loading
| Study group | Role | What they receive |
|---|---|---|
| Standard of Care | Experimental | Cleansing, debridement, wound documentation, off-loading Receives: Other: Standard of Care (Investigator Choice) |
| Amnio-Maxx® Dual Layer Amnion Patch | Experimental | Application of Amnio-Maxx® Dual Layer Amnion Patch Receives: Biological: Amnio-Maxx® Dual Layer Amnion Patch; Other: Standard of Care (Investigator Choice) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complete Ulcer Closure
Measured: 12 weeks
Expected percentage area reduction (PAR)
Measured: 12-weeks
Secondary outcomes (2)
Average percentage change from baseline in pain level related to the ulcer estimated from observed data using Numeric Pain Rating Scale (NPRS) and a Bayesian mixed effect model.
Measured: 12 weeks
Adverse events (AE)
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2025
- Study start14 Aug 2025
- Primary completion14 Aug 2026 (estimated)
- Study completion14 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic Foot Ulcer (DFU)Studies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 248 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Royal Biologics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07209475
- Sponsor's protocol ID
- Amnio-Maxx®
- Status last verified
- Oct 2025
- First submitted
- 2 Oct 2025
- Last updated
- 7 Oct 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Multicenter Trial, Examining the Effect of Amnio-Maxx on the Healing Rate of Chronic Diabetic Foot Ulcers.
- ClinicalTrials.gov ID
- NCT07209475
- Acronym / sponsor ID
- Amnio-Maxx®
- Conditions
- Diabetic Foot Ulcer (DFU), Amnio-Maxx
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 248 participants (estimated)
- Lead sponsor
- Royal BiologicsIndustry (pharma, biotech, devices)
- Study start
- 14 Aug 2025 (actual)
- Primary completion
- 14 Aug 2026 (estimated)
- Study completion
- 14 Aug 2026 (estimated)
- First posted
- 7 Oct 2025 (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.
This study will evaluate a cellular, acellular, matrix-like product (CAMP) and Standard of Care (SOC) versus SOC alone in the closure of nonhealing diabetic foot ulcers (DFUs). The study will evaluate Amnio-Maxx® Dual Layer Amnion Patch.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard of Care | Experimental | Other: Standard of Care (Investigator Choice)Cleansing, debridement, wound documentation, off-loading |
| Amnio-Maxx® Dual Layer Amnion Patch | Experimental | Biological: Amnio-Maxx® Dual Layer Amnion Patch, Other: Standard of Care (Investigator Choice)Application of Amnio-Maxx® Dual Layer Amnion Patch |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Potential subjects are required to meet all the following criteria for enrollment into the study and subsequent randomization.
- The potential subject is 18 years of age or older. At least 50% of the enrolled population must be > 65 years of age.
- The potential subject has a history of Type I or Type II Diabetes Mellitus requiring treatment by a physician with either oral medications and/or insulin replacement therapy.
- Potential subjects have an ulcer characterized by the following:
- Objectively, less than 20% healing in the two-week screening period prior to randomization.
Key exclusion criteria (18 listed)
- The Subject has a known life expectancy of < 1 year.
- Index ulcer has been present for >1 year.
- Patient does not have adequate 2-week historical data demonstrating < 20% area reduction.
- Subject is unable to comply with offloading device.
- Presence of any condition(s) which seriously compromises the subject's ability to complete this study or has a known history of poor adherence to medical treatment.
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 |
|---|---|---|
| Amnio-Maxx® Dual Layer Amnion PatchApplication of Amnio-Maxx® Dual Layer Amnion Patch | Biological | Amnio-Maxx® Dual Layer Amnion Patch |
| Standard of Care (Investigator Choice)Cleansing, debridement, wound documentation, off-loading | Other | Amnio-Maxx® Dual Layer Amnion Patch, Standard of Care |
Primary outcome
Complete Ulcer Closure
Time frame: 12 weeks
Expected percentage area reduction (PAR)
Time frame: 12-weeks
2 secondary outcomes
Average percentage change from baseline in pain level related to the ulcer estimated from observed data using Numeric Pain Rating Scale (NPRS) and a Bayesian mixed effect model.
Time frame: 12 weeks
Adverse events (AE)
Time frame: 12 weeks
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 Oct 2025.
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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.
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Amnio-Maxx® Dual Layer Amnion Patch in people with Diabetic Foot Ulcer (DFU) and Amnio-Maxx, run by Royal Biologics at 8 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 14 inclusion and 18 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 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Nicole Schrecngost (7246643843, nschrecengost@serenagroups.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Complete Ulcer Closure (time frame: 12 weeks). The study lists 2 primary outcomes in all. 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 Oct 2025.