Diabetic Foot Ulcer (DFU)NCT07223281
Real-World Effectiveness of Amniotic Membrane Allografts Versus Standard Wound Care in DFU, VLU, and PU
An observational study of Diabetic Foot Ulcer (DFU) and Venous Leg Ulcers (VLUs), run by Legacy Medical Consultants at 4 sites in United States.
Trial summary
This observational study will evaluate the real-world effectiveness of four amniotic membrane-based products (Zenith™, Orion™, SurGraft FT™, Complete ACA™) in addition to standard care, compared with standard care alone. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetic Foot Ulcer (DFU), Venous Leg Ulcers (VLUs), Pressure Ulcers, Bedsores, Decubitus Ulcer
- How many people
- 2,400 participants
- Where
- 4 sitesUnited States
- Study dates
- 25 Sep 2025to Dec 2025
- Phase
- Observational
- 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
Study population: Patients with DFU, VLU, or PU
Who may be able to join
- Adults ≥18; DFU/VLU/PU; sufficient observable timeline
Who cannot join
- Use of other advanced wound products, atypical ulcer etiology (e.g., malignancy, vasculitis); insufficient follow-up
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Podiatric Surgical Specialists
Clinton Township, Michigan, 48038
Colorado Foot and Ankle
Colorado Springs, Colorado, 80903
Comprehensive Occupational Medicine
Nitro, West Virginia, 25143
Advanced Wound Therapy
Tulsa, Oklahoma, 74137
About this study
Official title: Real-World Effectiveness of Amniotic Membrane Allografts Versus Standard Wound Care in Chronic Wound Healing: A Multi-Site Study in Diabetic Foot Ulcers (DFU), Venous Leg Ulcers (VLU), and Pressure Ulcers (PU)
This observational study will evaluate the real-world effectiveness of four amniotic membrane-based products (Zenith™, Orion™, SurGraft FT™, Complete ACA™) in addition to standard care, compared with standard care alone. The study will use complete electronic health records (EHR) from multiple wound care centers across the United States (2022-2025) to generate study data for product-treated and propensity score-matched standard care cohorts for each product-indication combination. The overall study comprises 12 parallel sub-studies (one for each product-wound type combination), each aiming to answer whether adding the product improves healing outcomes versus standard care alone in that indication. The primary endpoint is the proportion of wounds achieving complete closure within 12 weeks, with subgroup analyses by wound severity measures, age groups, and number of product applications. Secondary outcomes are time-to-healing, early wound improvement (≥50% reduction in wound area by 4 weeks), wound-related complications, and subgroup analyses.
- Conditions
- Diabetic Foot Ulcer (DFU), Venous Leg Ulcers (VLUs), Pressure Ulcers, Bedsores, Decubitus Ulcer
- Keywords
- real world evidence, wound healing
- Medical subject headings
- Diabetic Foot, Pressure Ulcer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Zenith™ + Standard care for DFU | Patients who received Zenith™ plus standard care for their DFU | |
| Orion™ + Standard care for DFU | Patients who received Orion™ plus standard care for their DFU | |
| SurGraft FT™ + Standard care for DFU | Patients who received SurGraft FT™ plus standard care for their DFU | |
| Complete ACA™ + Standard care for DFU | Patients who received Complete ACA™ plus standard care for their DFU | |
| Standard care alone for DFU | Patients who received standard care only for their DFU | |
| Zenith™ + Standard care for VLU | Patients who received Zenith™ plus standard care for their VLU | |
| Orion™ + Standard care for VLU | Patients who received Orion™ plus standard care for their VLU | |
| SurGraft FT™ + Standard care for VLU | Patients who received SurGraft FT™ plus standard care for their VLU | |
| Complete ACA™ + Standard care for VLU | Patients who received Complete ACA™ plus standard care for their VLU | |
| Standard care alone for VLU | Patients who received standard care only for their VLU | |
| Zenith™ + Standard care for PU | Patients who received Zenith™ plus standard care for their PU | |
| Orion™ + Standard care for PU | Patients who received Orion™ plus standard care for their PU | |
| SurGraft FT™ + Standard care for PU | Patients who received SurGraft FT™ plus standard care for their PU | |
| Complete ACA™ + Standard care for PU | Patients who received Complete ACA™ plus standard care for their PU | |
| Standard care alone for PU | Patients who received standard care only for their PU |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complete wound closure at 12 Weeks
Proportion of index wounds with 100% epithelialization, no drainage or dressings; confirmation on ≥1 follow-up within 60 days
Measured: From index visit to 12 weeks post-index
Secondary outcomes (3)
Time to complete wound closure
Time from the index visit to primary complete wound closure for wounds that heal during the study period
Measured: From index visit up to 24 months post-index
≥50% wound area reduction at 4 weeks
Proportion of patients whose wounds close greater than 50% within 4 weeks from the index visit
Measured: From index visit to 4 weeks post-index
Wound-related complications
Wound-related complications including infection requiring treatment, hospitalization, ED visits, and major or minor amputation
Measured: From index visit up to 24 months post-index
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2025
- Study start25 Sep 2025
- Primary completionNov 2025 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 2,400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Legacy Medical Consultants
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07223281
- Sponsor's protocol ID
- LMCRWE25
- Status last verified
- Oct 2025
- First submitted
- 29 Oct 2025
- Last updated
- 10 Nov 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Kahoun, J., Gorenstein, S., & Gillette, B. (2025). Real-World Performance of Amniotic Membrane Allografts for Chronic Wounds: Multi-Site Results from a Retrospective EHR Study. https://doi.org/10.5281/zenodo.17504472
Study at a glance
From the registry record, last updated by the sponsor on 10 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Real-World Effectiveness of Amniotic Membrane Allografts Versus Standard Wound Care in Chronic Wound Healing: A Multi-Site Study in Diabetic Foot Ulcers (DFU), Venous Leg Ulcers (VLU), and Pressure Ulcers (PU)
- ClinicalTrials.gov ID
- NCT07223281
- Acronym / sponsor ID
- LMCRWE25
- Conditions
- Diabetic Foot Ulcer (DFU), Venous Leg Ulcers (VLUs), Pressure Ulcers, Bedsores, Decubitus Ulcer
- Keywords
- real world evidence, wound healing
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 2,400 participants (estimated)
- Lead sponsor
- Legacy Medical ConsultantsIndustry (pharma, biotech, devices)
- Study start
- 25 Sep 2025 (actual)
- Primary completion
- Nov 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 31 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 observational study will evaluate the real-world effectiveness of four amniotic membrane-based products (Zenith™, Orion™, SurGraft FT™, Complete ACA™) in addition to standard care, compared with standard care alone. The study will use complete electronic health records (EHR) from multiple wound care centers across the United States (2022-2025) to generate study data for product-treated and propensity score-matched standard care cohorts for each product-indication combination. The overall study comprises 12 parallel sub-studies (one for each product-wound type combination), each aiming to answer whether adding the product improves healing outcomes versus standard care alone in that indication. The primary endpoint is the proportion of wounds achieving complete closure within 12 weeks, with subgroup analyses by wound severity measures, age groups, and number of product applications. Secondary outcomes are time-to-healing, early wound improvement (≥50% reduction in wound area by 4 weeks), wound-related complications, and subgroup analyses.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 15
| Arm | Type | Receives |
|---|---|---|
| Zenith™ + Standard care for DFU | – | –Patients who received Zenith™ plus standard care for their DFU |
| Orion™ + Standard care for DFU | – | –Patients who received Orion™ plus standard care for their DFU |
| SurGraft FT™ + Standard care for DFU | – | –Patients who received SurGraft FT™ plus standard care for their DFU |
| Complete ACA™ + Standard care for DFU | – | –Patients who received Complete ACA™ plus standard care for their DFU |
| Standard care alone for DFU | – | –Patients who received standard care only for their DFU |
| Zenith™ + Standard care for VLU | – | –Patients who received Zenith™ plus standard care for their VLU |
| Orion™ + Standard care for VLU | – | –Patients who received Orion™ plus standard care for their VLU |
| SurGraft FT™ + Standard care for VLU | – | –Patients who received SurGraft FT™ plus standard care for their VLU |
| Complete ACA™ + Standard care for VLU | – | –Patients who received Complete ACA™ plus standard care for their VLU |
| Standard care alone for VLU | – | –Patients who received standard care only for their VLU |
| Zenith™ + Standard care for PU | – | –Patients who received Zenith™ plus standard care for their PU |
| Orion™ + Standard care for PU | – | –Patients who received Orion™ plus standard care for their PU |
| SurGraft FT™ + Standard care for PU | – | –Patients who received SurGraft FT™ plus standard care for their PU |
| Complete ACA™ + Standard care for PU | – | –Patients who received Complete ACA™ plus standard care for their PU |
| Standard care alone for PU | – | –Patients who received standard care only for their PU |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with DFU, VLU, or PU
Key inclusion criteria (1 listed)
- Adults ≥18; DFU/VLU/PU; sufficient observable timeline
Key exclusion criteria (1 listed)
- Use of other advanced wound products, atypical ulcer etiology (e.g., malignancy, vasculitis); insufficient follow-up
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Complete wound closure at 12 Weeks
Time frame: From index visit to 12 weeks post-index
Proportion of index wounds with 100% epithelialization, no drainage or dressings; confirmation on ≥1 follow-up within 60 days
3 secondary outcomes
Time to complete wound closure
Time frame: From index visit up to 24 months post-index
≥50% wound area reduction at 4 weeks
Time frame: From index visit to 4 weeks post-index
Wound-related complications
Time frame: From index visit up to 24 months post-index
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 10 Nov 2025.
- Results publicationKahoun, J., Gorenstein, S., & Gillette, B. (2025). Real-World Performance of Amniotic Membrane Allografts for Chronic Wounds: Multi-Site Results from a Retrospective EHR Study. https://doi.org/10.5281/zenodo.17504472
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetic Foot Ulcer (DFU) and Venous Leg Ulcers (VLUs), run by Legacy Medical Consultants at 4 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 1 inclusion and 1 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: under way, not looking for participants, as of the sponsor's last update on 10 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Complete wound closure at 12 Weeks (time frame: From index visit to 12 weeks post-index). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07223281, which also lists 1 linked publication.
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 10 Nov 2025.