Diabetic FootPhase 4NCT07159282
A Multicenter, Prospective, Controlled Clinical Trial Evaluating the Efficacy of a Single Layer Placental-based Allograft and Standard of Care in the Management of Nonhealing Diabetic Foot Ulcers
A Phase 4 study testing XWRAP in people with Diabetic Foot and Foot Ulcer, run by Applied Biologics, LLC at 1 site in United States.
Trial summary
A multicenter, prospective, controlled clinical trial evaluating the efficacy of a single layer placental-based allograft and standard of care in the management of nonhealing diabetic foot ulcers. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetic Foot, Foot Ulcer, Ulcer Foot
- What is being tested?
- XWRAP
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Aug 2025to Aug 2027
- 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
- The potential subject must be at least 18 years of age or older.
- The potential subject must have a diagnosis of type 1 or 2 Diabetes mellitus.
- If the potential subject has two or more ulcers, the target ulcer must be the same ulcer treated in the CAMPX study.
- The potential subject must consent to using the prescribed offloading method for the duration of the study.
- The potential subject must agree to attend the weekly study visits required by the protocol.
- The potential subject must be willing and able to participate in the informed consent process.
- The potential subject must have participated in the CAMPX trial in the SOC only arm and NOT achieved complete closure by the 12-week endpoint.
Who cannot join
- The potential subject is known to have a life expectancy of < 6 months.
- The potential subject's target ulcer is not secondary to diabetes.
- The target ulcer is infected or there is cellulitis in the surrounding skin.
- The target ulcer exposes tendon or bone.
- There is evidence of osteomyelitis complicating the target ulcer.
- There is an infection in the target ulcer or in a remote location that requires systemic antibiotic therapy.
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- The potential subject is receiving immunosuppressants (including systemic corticosteroids at doses greater than 10 mg of prednisone per day or equivalent) or cytotoxic chemotherapy or is taking medications that the PI believes will interfere with wound healing (e.g., biologics).
- The potential subject has applied topical steroids to the ulcer surface within one month of initial screening.
- The potential subject with a previous partial amputation on the affected foot that results in a deformity that impedes proper offloading of the target ulcer.
- The potential subject has glycated hemoglobin (HbA1c) greater than or equal to 12% within 3 months of the initial screening visit.
- The potential subject has an acute Charcot foot, or an inactive Charcot foot, which impedes proper offloading of the target ulcer.
- The potential subject is a woman who is pregnant or considering becoming pregnant within the next 6 months.
- The potential subject has end stage renal disease requiring dialysis.
- The potential subject, in the opinion of the investigator, has a medical or psychological condition that may interfere with study assessments.
- The potential subject has a malnutrition indicator score <17 as measured on the Mini Nutritional Assessment.
- The potential subject did not participate in the CAMPX trial.
- The potential subject participated in the CAMPX trial and was not randomized to the SOC only arm.
- The potential subject participated in the CAMPX trial and achieved complete closure.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Royal Research
Hollywood, Florida, 33024
Yaliliy Perez, 954-940-0208, yalilyp@royalresearchcorp.com
About this study
A multicenter, prospective, controlled clinical trial evaluating the efficacy of a single layer placental-based allograft and standard of care in the management of nonhealing diabetic foot ulcers.
Read the detailed description
This study follows a rescue design: patients in the SOC arm who fail to heal during the CAMPX Prospective Multicenter Randomized Controlled Clinical Trial will enter the Rescue trial and receive the study product.
Patients enrolled in this trial must still meet medical necessity criteria for cellular, acellular, matrix-like, products (CAMPs) recently published by the Medicare Administrative Contractor's (MAC) in their local coverage determinations (LCD).
- Conditions
- Diabetic Foot, Foot Ulcer, Ulcer Foot, DFU, Foot Ulcer Due to Type 2 Diabetes Mellitus, Foot Ulcer Due to Type 1 Diabetes Mellitus
- Being tested
- XWRAP
- Medical subject headings
- Diabetic Foot, Foot Ulcer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
XWRAPOther
Application of XWRAP + standard of care for up to 12 weeks.
| Study group | Role | What they receive |
|---|---|---|
| XWRAP | Experimental | Single-layer amniotic membrane + standard of care. Receives: Other: XWRAP |
What is being measured
The primary outcome is the main question the study is designed to answer.
Wound Closure
The percentage of target ulcers achieving complete wound closure in 12 weeks.
Measured: 1-12 Weeks
Secondary outcomes (6)
Time to Closure
Time to closure for the target ulcer.
Measured: 1-12 weeks
Wound Area Reduction
Percentage wound area reduction from TV-1 to TV-13 measured weekly with digital photographic planimetry, using imaging device, and physical examination.
Measured: 1-12 weeks
Adverse Events
The number of product- or procedure- related adverse events.
Measured: 1-12 Weeks
Wound Quality of Life
Change in quality-of-Life based on the Wound Quality of Life Questionarie [Time Frame: TV-1, TV-4, TV-8, TV-12 / Final Visit].
Measured: 1-12 weeks
Forgotten Wound Score
Change in quality-of-Life based on the Forgotten Wound Score questionaire [Time Frame: TV-1, TV-4, TV-8, TV-12 / Final Visit]
Measured: 1-12 weeks
Pain, Enjoyment of Life, and General Activity Scale
Change in pain in the target ulcer assessed using the PEG scale [Time Frame: TV-1 to TV-13].
Measured: 1-12 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2025
- Study start26 Aug 2025
- Primary completionAug 2027 (estimated)
- Study completionAug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic FootStudies 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
- Not applicable
- Intervention model
- Single group
- Model description
- This study follows a rescue design: patients in the SOC arm who fail to heal during the CAMPX Prospective Multicenter Randomized Controlled Clinical Trial will enter the Rescue trial and receive the study product.
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Applied Biologics, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- SerenaGroup, Inc.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07159282
- Sponsor's protocol ID
- RescueX
- Status last verified
- Aug 2025
- First submitted
- 29 Aug 2025
- Last updated
- 11 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Prospective, Controlled Clinical Trial Evaluating the Efficacy of a Single Layer Placental-based Allograft and Standard of Care in the Management of Nonhealing Diabetic Foot Ulcers
- ClinicalTrials.gov ID
- NCT07159282
- Acronym / sponsor ID
- RescueX
- Conditions
- Diabetic Foot, Foot Ulcer, Ulcer Foot, DFU, Foot Ulcer Due to Type 2 Diabetes Mellitus, Foot Ulcer Due to Type 1 Diabetes Mellitus
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Applied Biologics, LLCIndustry (pharma, biotech, devices)
- Collaborators
- SerenaGroup, Inc.
- Study start
- 26 Aug 2025 (actual)
- Primary completion
- Aug 2027 (estimated)
- Study completion
- Aug 2027 (estimated)
- First posted
- 8 Sep 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.
A multicenter, prospective, controlled clinical trial evaluating the efficacy of a single layer placental-based allograft and standard of care in the management of nonhealing diabetic foot ulcers.
Detailed description
This study follows a rescue design: patients in the SOC arm who fail to heal during the CAMPX Prospective Multicenter Randomized Controlled Clinical Trial will enter the Rescue trial and receive the study product.
Patients enrolled in this trial must still meet medical necessity criteria for cellular, acellular, matrix-like, products (CAMPs) recently published by the Medicare Administrative Contractor's (MAC) in their local coverage determinations (LCD).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This study follows a rescue design: patients in the SOC arm who fail to heal during the CAMPX Prospective Multicenter Randomized Controlled Clinical Trial will enter the Rescue trial and receive the study product.
| Arm | Type | Receives |
|---|---|---|
| XWRAP | Experimental | Other: XWRAPSingle-layer amniotic membrane + standard of care. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- The potential subject must be at least 18 years of age or older.
- The potential subject must have a diagnosis of type 1 or 2 Diabetes mellitus.
- If the potential subject has two or more ulcers, the target ulcer must be the same ulcer treated in the CAMPX study.
- The potential subject must consent to using the prescribed offloading method for the duration of the study.
- The potential subject must agree to attend the weekly study visits required by the protocol.
Key exclusion criteria (18 listed)
- The potential subject is known to have a life expectancy of < 6 months.
- The potential subject's target ulcer is not secondary to diabetes.
- The target ulcer is infected or there is cellulitis in the surrounding skin.
- The target ulcer exposes tendon or bone.
- There is evidence of osteomyelitis complicating the target ulcer.
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 |
|---|---|---|
| XWRAPApplication of XWRAP + standard of care for up to 12 weeks. | Other | XWRAP |
Primary outcome
Wound Closure
Time frame: 1-12 Weeks
The percentage of target ulcers achieving complete wound closure in 12 weeks.
6 secondary outcomes
Time to Closure
Time frame: 1-12 weeks
Wound Area Reduction
Time frame: 1-12 weeks
Adverse Events
Time frame: 1-12 Weeks
Wound Quality of Life
Time frame: 1-12 weeks
Forgotten Wound Score
Time frame: 1-12 weeks
Pain, Enjoyment of Life, and General Activity Scale
Time frame: 1-12 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 11 Feb 2026.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing XWRAP in people with Diabetic Foot and Foot Ulcer, run by Applied Biologics, LLC at 1 site 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 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 11 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 Bennett Sarver (1-833-865-6300, info@serenagroups.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Wound Closure (time frame: 1-12 Weeks). 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 11 Feb 2026.