Diabete MellitusPhase 4NCT07326553
Efficacy of Placental Membrane Dressings in Accelerating Diabetic Foot Healing
A Phase 4 study testing Placental Membrane in people with Diabete Mellitus and Foot Ulcer Chronic, run by BioXTek at 2 sites in United States.
Trial summary
Evaluation of Efficacy of Placental Membrane Dressings in Accelerating Diabetic Foot Healing Read more about this study
- Who is it for?
- Ages 45 to 85 years
- Conditions the study is for
- Diabete Mellitus, Foot Ulcer Chronic
- What is being tested?
- Placental Membrane
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 2 sitesUnited States
- Study dates
- 1 Dec 2025to 31 Dec 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 45 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient has signed the informed consent form.
- Male or female patient at least 18 years of age or older, as of the date of the screening visit.
- Confirmed diagnosis of Type 1 or Type 2 DM.
- Has a DFU that is located below the malleoli ranging in size from 1.0 cm2 to 20.0 cm2, post debridement, when measured by the investigator staff at the screening visit using the eKare device.
- The DFU has been present for ≥4 weeks and ≤12 months.
- The DFU is non-healing as defined as <30% reduction in size in response to standard of care from Screening (Visit 1) to Study Day 1 (Visit 2).
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- If more than one ulcer is present the selected target ulcer must be at least 2 cm from the nearest edge of any adjacent ulcers.
- The depth of the target foot ulcer is graded as Wagner Grade I or II, i.e., with no evidence of exposed muscle, tendon, bone, or joint capsule.
- Arterial supply adequacy to the foot with the target ulcer confirmed by any one of the following and documented in medical record/EMR:
- Great toe pressure ≥ 40 mm/Hg
- Systolic blood pressure Ankle Brachial Index (ABI) in the range ≥ 0.70 ≤ 1.20
- TcPO2 ≥ 30 mmHg from the foot
- Toe Brachial Index or TBI ≥ 0.65
- Willing to follow all instructions given by the Investigator, return for all visits, and adhere to off-loading protocols while on the study.
Who cannot join
- Hemoglobin A1c (HbA1c) level is > 10%.
- Chronic oral steroid use of > 7.5 mg daily within the previous 30 days preceding screening.
- Chronic oral or parenteral corticosteroids, or any cytotoxic agents within the previous 30 days preceding screening.
- Has tested positive for Human Immunodeficiency Virus (HIV) or has Acquired Immune Deficiency Syndrome (AIDS).
- Has malignancy or history of cancer in 5 years preceding the screening visit other than non- melanoma skin cancer.
- Pregnant or lactating women.
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- Women of child-bearing potential who are unwilling to avoid pregnancy or use an effective form of birth control.
- Currently on dialysis or planning to start dialysis.
- Is currently enrolled or participated in another device, drug, or biological trial within 30 days of screening.
- Has used wound treatments with enzymes, growth factors, living skin, dermal substitutes including other amniotic or umbilical cord tissue therapies, or other advanced biological therapies within the last 30 days.
- Current use of topical anti-microbial or silver-containing products.
- Target ulcer is over an active or inactive Charcot deformity.
- The depth of the target ulcer is graded as Wagner Grade III or higher, i.e., with evidence of exposed muscle, tendon, bone, and/or joint capsule.
- Gangrene is present on any part of the affected foot.
- Current suspicion of osteomyelitis, cellulitis, or other clinical signs or symptoms of target ulcer infection.
- Any previous use of human placental membrane applied to the target ulcer.
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
Axsendo Clinical Research
Houston, Texas, 77058
Kassiy Pierce, 281-377-3988, kassidy.tommapierce@axsendoclinical.com
Lepow, MD
- Recruiting
Axsendo
Phoenix, Arizona, 85024
Tasha Marriot, 602-730-9500, tasha.marriott@axsendoclinical.com
Udupa, MD
About this study
Official title: A Randomized, Open-Label Trial Evaluating the Efficacy of Placental Membrane Dressings in Accelerating Diabetic Foot Healing Compared to Matched Historical Controls Receiving Standard of Care
Evaluation of Efficacy of Placental Membrane Dressings in Accelerating Diabetic Foot Healing
- Conditions
- Diabete Mellitus, Foot Ulcer Chronic
- Being tested
- Placental Membrane
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Placental MembraneBiological
Dehyrdated Placental Membrane
| Study group | Role | What they receive |
|---|---|---|
| Placental Membrane Dressing | Experimental | Not described Receives: Biological: Placental Membrane |
| Historical Controls | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Wound Closure
Proportion of subjects achieving ≥90% wound closure.
Measured: 12 weeks
Secondary outcomes (2)
Time to wound closure
Time in number of days to ≥90% wound closure over the 12- week treatment period, starting from baseline to the time of initial observation of wound closure
Measured: 12 weeks
Percent Change
Percent change from baseline in wound surface area (cm2)
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 posted8 Jan 2026
- Study start1 Dec 2025
- Primary completion31 Jul 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabete MellitusStudies 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
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Compared to historical controls
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- BioXTek
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07326553
- Sponsor's protocol ID
- BX-PM-DW-101
- Status last verified
- Jan 2026
- First submitted
- 6 Jan 2026
- Last updated
- 8 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Plan Description De-identified individual participant data (IPD) collected during the study will be made available to qualified researchers. Shared IPD will include participant-level demographic and baseline characteristics, wound characteristics, treatment assignment, and outcome measures related to diabetic foot ulcer healing (e.g., wound closure status, time to closure, wound area measurements, and adverse event data), as well as relevant analyzable datasets. Data will be shared in a de-identified format and will not include direct identifiers. Access Criteria Access to de-identified IPD will be provided upon reasonable request to the study sponsor/principal investigator after publication of the primary results. Requests must include a research proposal and statistical analysis plan and will be reviewed for scientific merit and compliance with applicable ethical and privacy requirements. Data will be shared under a data use agreement and may be accessed through a secure data-shar
Study at a glance
From the registry record, last updated by the sponsor on 8 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Open-Label Trial Evaluating the Efficacy of Placental Membrane Dressings in Accelerating Diabetic Foot Healing Compared to Matched Historical Controls Receiving Standard of Care
- ClinicalTrials.gov ID
- NCT07326553
- Acronym / sponsor ID
- BX-PM-DW-101
- Conditions
- Diabete Mellitus, Foot Ulcer Chronic
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- BioXTekIndustry (pharma, biotech, devices)
- Study start
- 1 Dec 2025 (actual)
- Primary completion
- 31 Jul 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 8 Jan 2026 (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.
Evaluation of Efficacy of Placental Membrane Dressings in Accelerating Diabetic Foot Healing
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Compared to historical controls
| Arm | Type | Receives |
|---|---|---|
| Placental Membrane Dressing | Experimental | Biological: Placental Membrane |
| Historical Controls | No intervention | – |
Who may qualify
- Ages
- 45 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Patient has signed the informed consent form.
- Male or female patient at least 18 years of age or older, as of the date of the screening visit.
- Confirmed diagnosis of Type 1 or Type 2 DM.
- Has a DFU that is located below the malleoli ranging in size from 1.0 cm2 to 20.0 cm2, post debridement, when measured by the investigator staff at the screening visit using the eKare device.
- The DFU has been present for ≥4 weeks and ≤12 months.
Key exclusion criteria (16 listed)
- Hemoglobin A1c (HbA1c) level is > 10%.
- Chronic oral steroid use of > 7.5 mg daily within the previous 30 days preceding screening.
- Chronic oral or parenteral corticosteroids, or any cytotoxic agents within the previous 30 days preceding screening.
- Has tested positive for Human Immunodeficiency Virus (HIV) or has Acquired Immune Deficiency Syndrome (AIDS).
- Has malignancy or history of cancer in 5 years preceding the screening visit other than non- melanoma skin cancer.
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 |
|---|---|---|
| Placental MembraneDehyrdated Placental Membrane | Biological | Placental Membrane Dressing |
Primary outcome
Wound Closure
Time frame: 12 weeks
Proportion of subjects achieving ≥90% wound closure.
2 secondary outcomes
Time to wound closure
Time frame: 12 weeks
Percent Change
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 8 Jan 2026.
- Individual participant dataSharing planned: Yes. Plan Description De-identified individual participant data (IPD) collected during the study will be made available to qualified researchers. Shared IPD will include participant-level demographic and baseline characteristics, wound characteristics, treatment assignment, and outcome measures related to diabetic foot ulcer healing (e.g., wound closure status, time to closure, wound area measurements, and adverse event data), as well as relevant analyzable datasets. Data will be shared in a de-identified format and will not include direct identifiers. Access Criteria Access to de-identified IPD will be provided upon reasonable request to the study sponsor/principal investigator after publication of the primary results. Requests must include a research proposal and statistical analysis plan and will be reviewed for scientific merit and compliance with applicable ethical and privacy requirements. Data will be shared under a data use agreement and may be accessed through a secure data-shar
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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 Phase 4 study testing Placental Membrane in people with Diabete Mellitus and Foot Ulcer Chronic, run by BioXTek 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 14 inclusion and 16 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 8 Jan 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.
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 Josh Arnold (302-604-4532, Josh.Arnold@Purity-Health.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: 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 8 Jan 2026.