Diabetic Foot UlcerPhase 3AB BIOH - DFUNCT07852338
a Prospective, Multicenter, Randomized Controlled Trial, With a Non-randomized Sentinel Cohort, Evaluating the Efficacy of Bioxheal, a Single-layer Placental-derived Biologic in Nonhealing Diabetic Foot Ulcers
A Phase 3 study testing BIOxHEAL (human amniotic membrane allograft) in people with Diabetic Foot Ulcer and Amniotic Membrane Placental Allograft, run by Applied Biologics, LLC at 1 site in United States.
Trial summary
BIOxHEAL is an investigational placental-derived biologic being evaluated for the treatment of nonhealing diabetic foot ulcers. Adults with type 1 or type 2 diabetes who have a diabetic foot ulcer that has not healed with standard wound care may be eligible to participate. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetic Foot Ulcer, Amniotic Membrane Placental Allograft, Biologic
- What is being tested?
- BIOxHEAL (human amniotic membrane allograft)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 253 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Oct 2026to Sep 2027
- Phase
- Phase 3
- 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
- Participants must be at least 18 years of age or older. Participants must have a diagnosis of type 1 or 2 diabetes mellitus. At randomization (or enrollment for the sentinel cohort), participants must have a target ulcer with a minimum surface area of 1.0 cm2 and a maximum surface area of 25.0 cm2 measured post debridement.
- The target ulcer must have been present for a minimum of 4 weeks and a maximum of 52 weeks of standard of care prior to the initial screening visit.
- The target ulcer must be located on the foot with at least 50% of the ulcer below the malleolus.
- The target ulcer must be Wagner Grade 1 extending at least through the dermis or subcutaneous tissue.
- The affected limb must have adequate perfusion confirmed by vascular assessment. Any of the following methods performed within 3 months of the first screening visit are acceptable:
- ABI greater than or equal to 0.7 and less than or equal to 1.3 TBI greater than or equal to 0.6 TCOM greater than or equal to 40 mmHg Arterial Doppler ultrasound with biphasic dorsalis pedis and posterior tibial vessels at the level of the ankle on the extremity where the index ulcer is located If the participant has two or more ulcers, they must be separated by at least 2 cm. The largest ulcer satisfying the inclusion and exclusion criteria will be designated as the target ulcer.
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- The participant must consent to using the prescribed offloading method for the duration of the study.
- The participant must agree to attend the weekly study visits required by the protocol.
- The participant must be willing and able to participate in the informed consent process.
- The participant must have a suitable living environment to manage prescribed offloading and wound care management.
Who cannot join
- Known life expectancy of less than 6 months. Target ulcer is not secondary to diabetes. Wagner Grade 2 to 5 ulcers. Target ulcer is infected, or there is cellulitis in the surrounding skin.
- Evidence of osteomyelitis complicating the target ulcer, based on clinical assessment supported by at least one of the following:
- Imaging (for example, plain radiography, MRI, or nuclear medicine study) consistent with osteomyelitis Positive bone culture Abnormal inflammatory markers (for example, ESR, CRP) in conjunction with clinical signs highly suggestive of osteomyelitis per Investigator judgment - Documentation of the basis for diagnosing or excluding osteomyelitis must be available in the participant's source documents Infection in the target ulcer or in a remote location that requires systemic antibiotic therapy.
- Receiving immunosuppressants (including systemic corticosteroids at doses greater than 10 mg of prednisone per day or equivalent) or cytotoxic chemotherapy.
- Topical application of steroids to the ulcer surface within one month of initial screening.
- Previous partial amputation on the affected foot, if the resulting deformity impedes proper offloading of the target ulcer.
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- Glycated hemoglobin (HbA1c) greater than or equal to 12% within 3 months of the initial screening visit.
- The surface area of the target ulcer has reduced in size by more than 40% between Screening Visit 1 and Treatment Visit 1 during the protocol-defined screening period.
- Acute Charcot foot, or an inactive Charcot foot, that impedes proper offloading of the target ulcer.
- Women who are pregnant or considering becoming pregnant within the next 6 months.
- Male or female participants who are unwilling or unable to comply with the required contraceptive measures for the duration of study participation.
- End stage renal disease requiring dialysis. Serum creatinine level greater than 3.0 mg/dL. Aspartate aminotransferase (AST, GOT) and/or alanine aminotransferase (ALT, GPT) greater than 3 times the upper limit of normal.
- A medical or psychological condition that, in the opinion of the investigator, may interfere with study assessments.
- Treated with hyperbaric oxygen therapy or a Cellular and/or Tissue Product (CTP) in the 30 days prior to the initial screening visit.
- Mini Nutritional Assessment (MNA) screening score below 12.
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
NOMS Ankle and Foot Care Center
Boardman, Ohio, 44512
Lawrence DiDomenico, DPM, 330-953-3222, ld5353@aol.com
About this study
Official title: a Randomized Controlled Multicenter Clinical Trial, Evaluating the Efficacy of a Single Layer Placental-based Biologic and Standard of Care Versus Standard of Care Alone in the Management of Nonhealing Diabetic Foot Ulcers.
BIOxHEAL is an investigational placental-derived biologic being evaluated for the treatment of nonhealing diabetic foot ulcers. Adults with type 1 or type 2 diabetes who have a diabetic foot ulcer that has not healed with standard wound care may be eligible to participate. Participants in the randomized phase are assigned by chance in a 2:1 ratio to receive either BIOxHEAL administered topically in combination with standard of care (SOC), or SOC alone. Treatment is administered once weekly for up to 12 weeks or until complete ulcer closure. The primary objective is to evaluate whether BIOxHEAL plus SOC increases the proportion of target ulcers achieving complete closure at Week 12 compared with SOC alone.
Read the detailed description
Phase 3, multicenter, prospective, open-label, randomized controlled study conducted at up to 30 U.S. clinical centers. A non-randomized sentinel cohort (5 completed participants required, with up to 10 participants enrolled) will first receive BIOxHEAL plus SOC to assess early safety. Following DSMB review and FDA authorization to proceed, 243 participants will be randomized 2:1 to BIOxHEAL plus SOC or SOC alone, with randomization stratified by baseline ulcer area and ulcer duration. BIOxHEAL is administered topically once weekly for up to 12 weeks or until complete ulcer closure. Complete closure is confirmed approximately 2 weeks later. Participants are subsequently followed for 3 months.
- Being tested
- Standard of Care, BIOxHEAL (human amniotic membrane allograft)
- Keywords
- Diabetic Foot Ulcer, Chronic Wound Wound Healing
- Medical subject headings
- Diabetic Foot
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard of CareOther
Protocol-defined standard of care (SOC) for diabetic foot ulcers, performed at each study visit: wound cleansing with sterile saline, sharp debridement as clinically indicated, a non-adherent silicone primary dressing with an absorbent secondary dressing to maintain a moist wound environment, offloading for plantar and pressure-bearing ulcers (Foot Defender boot, Total Contact Cast, or Medical Monitor-approved equivalent), and diabetes education and nutritional support, including smoking cessation counseling for current smokers.
BIOxHEAL (human amniotic membrane allograft)Biological
BIOxHEAL is an investigational, sterile, single-use biologic derived from human amniotic membrane. BIOxHEAL is administered topically to the target ulcer once weekly in combination with protocol-defined standard of care for up to 12 weeks or until complete ulcer closure. Each unit is individually packaged for single-patient, one-time use.
| Study group | Role | What they receive |
|---|---|---|
| Sentinel Cohort: BIOxHEAL + SOC | Experimental | Non-randomized sentinel cohort (5 completed participants required, up to 10 enrolled). Participants receive BIOxHEAL administered topically once weekly plus SOC for up to 12 weeks or until complete ulcer closure, to assess early safety before the randomized phase. Receives: Other: Standard of Care; Biological: BIOxHEAL (human amniotic membrane allograft) |
| Randomized: SOC Alone | Active comparator | Participants randomized 2:1 to receive protocol-defined SOC alone, with weekly treatment visits for up to 12 weeks or until complete ulcer closure, with closure confirmed approximately 2 weeks later. Receives: Other: Standard of Care |
| Randomized: BIOxHEAL + SOC | Experimental | Participants randomized 2:1 to receive BIOxHEAL administered topically once weekly plus SOC for up to 12 weeks or until complete ulcer closure, with closure confirmed approximately 2 weeks later. Receives: Biological: BIOxHEAL (human amniotic membrane allograft) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of target ulcers with complete wound closure at Week 12
Complete closure is defined as 100% epithelialization, assessed by the Investigator and confirmed by blinded, independent wound evaluators. Compared between BIOxHEAL plus standard of care and standard of care alone.
Measured: Baseline to Week 12
Secondary outcomes (5)
Proportion of target ulcers with complete wound closure at Week 8
Complete closure is defined as 100% epithelialization, assessed by the Investigator and confirmed by blinded, independent wound evaluators. Compared between BIOxHEAL plus standard of care and standard of care alone.
Measured: Baseline to Week 8.
Proportion of participants with treatment-emergent adverse events (TEAEs), serious adverse events (SAEs) and adverse events of special interest (AESIs)
Number and proportion of participants with TEAEs, including SAEs and AESIs. Compared between BIOxHEAL plus standard of care and standard of care alone.
Measured: From first treatment through the end of follow-up (at least 3 months after complete wound healing, or after Visit 13 if not healed), assessed up to approximately 6 months
Mean change in Wound Quality-of-Life (wQOL) score from baseline to Week 12
Change in wQOL questionnaire score. Compared between BIOxHEAL plus standard of care and standard of care alone.
Measured: Baseline to 12 weeks
Proportion of participants with major and minor lower extremity amputations, and number and frequency of amputations
Number and frequency of major and minor lower extremity amputations occurring during the study period.
Measured: From first treatment through the end of the follow-up period, assessed up to approximately 6 months
Proportion of participants with completely closed diabetic foot ulcers at any time during the study
Complete closure is defined as 100% epithelialization, assessed by the Investigator and confirmed by blinded, independent wound evaluators. Compared between BIOxHEAL plus standard of care and standard of care alone.
Measured: From first treatment until complete wound closure (100% epithelialization) is first confirmed, assessed up to approximately 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2026
- Study start8 Oct 2026 (estimated)
- Primary completionSep 2027 (estimated)
- Study completionSep 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Phase 3, multicenter, prospective, open-label, randomized controlled study at up to 30 U.S. centers. A non-randomized sentinel cohort (5 completed participants required, up to 10 enrolled) first receives BIOxHEAL plus standard of care (SOC) to assess early safety. After Data and Safety Monitoring Board (DSMB) review and FDA approval, 243 participants are randomized 2:1 to BIOxHEAL plus SOC or SOC alone, stratified by baseline ulcer area and ulcer duration. Treatment is given weekly for up to 12 weeks or until complete ulcer closure, which is confirmed 2 weeks later, followed by 3 months of follow-up.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 253 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Applied Biologics, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Charles Zelen, DPM, Study director, Professional Education & Research Institute (PERI)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07852338
- Sponsor's protocol ID
- AB BIOH-26-001 Protocol v4.0
- Other IDs
- IND 32533
- Acronym
- AB BIOH - DFU
- Status last verified
- Oct 2026
- First submitted
- 25 Sep 2026
- Last updated
- 16 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: There is currently no plan to make individual participant data (IPD) available to other researchers. The Sponsor will consider reasonable requests for de-identified data after completion of the study and regulatory review, subject to participant privacy protections and applicable agreements.
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- a Randomized Controlled Multicenter Clinical Trial, Evaluating the Efficacy of a Single Layer Placental-based Biologic and Standard of Care Versus Standard of Care Alone in the Management of Nonhealing Diabetic Foot Ulcers.
- ClinicalTrials.gov ID
- NCT07852338
- Acronym / sponsor ID
- AB BIOH - DFU / AB BIOH-26-001 Protocol v4.0
- Keywords
- Diabetic Foot Ulcer, Chronic Wound Wound Healing
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 253 participants (estimated)
- Lead sponsor
- Applied Biologics, LLCIndustry (pharma, biotech, devices)
- Study start
- 8 Oct 2026 (estimated)
- Primary completion
- Sep 2027 (estimated)
- Study completion
- Sep 2027 (estimated)
- First posted
- 1 Oct 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.
BIOxHEAL is an investigational placental-derived biologic being evaluated for the treatment of nonhealing diabetic foot ulcers. Adults with type 1 or type 2 diabetes who have a diabetic foot ulcer that has not healed with standard wound care may be eligible to participate. Participants in the randomized phase are assigned by chance in a 2:1 ratio to receive either BIOxHEAL administered topically in combination with standard of care (SOC), or SOC alone. Treatment is administered once weekly for up to 12 weeks or until complete ulcer closure. The primary objective is to evaluate whether BIOxHEAL plus SOC increases the proportion of target ulcers achieving complete closure at Week 12 compared with SOC alone.
Detailed description
Phase 3, multicenter, prospective, open-label, randomized controlled study conducted at up to 30 U.S. clinical centers. A non-randomized sentinel cohort (5 completed participants required, with up to 10 participants enrolled) will first receive BIOxHEAL plus SOC to assess early safety. Following DSMB review and FDA authorization to proceed, 243 participants will be randomized 2:1 to BIOxHEAL plus SOC or SOC alone, with randomization stratified by baseline ulcer area and ulcer duration. BIOxHEAL is administered topically once weekly for up to 12 weeks or until complete ulcer closure. Complete closure is confirmed approximately 2 weeks later. Participants are subsequently followed for 3 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
- Model description
- Phase 3, multicenter, prospective, open-label, randomized controlled study at up to 30 U.S. centers. A non-randomized sentinel cohort (5 completed participants required, up to 10 enrolled) first receives BIOxHEAL plus standard of care (SOC) to assess early safety. After Data and Safety Monitoring Board (DSMB) review and FDA approval, 243 participants are randomized 2:1 to BIOxHEAL plus SOC or SOC alone, stratified by baseline ulcer area and ulcer duration. Treatment is given weekly for up to 12 weeks or until complete ulcer closure, which is confirmed 2 weeks later, followed by 3 months of follow-up.
| Arm | Type | Receives |
|---|---|---|
| Sentinel Cohort: BIOxHEAL + SOC | Experimental | Other: Standard of Care, Biological: BIOxHEAL (human amniotic membrane allograft)Non-randomized sentinel cohort (5 completed participants required, up to 10 enrolled). Participants receive BIOxHEAL administered topically once weekly plus SOC for up to 12 weeks or until complete ulcer closure, to assess early safety before the randomized phase. |
| Randomized: SOC Alone | Active comparator | Other: Standard of CareParticipants randomized 2:1 to receive protocol-defined SOC alone, with weekly treatment visits for up to 12 weeks or until complete ulcer closure, with closure confirmed approximately 2 weeks later. |
| Randomized: BIOxHEAL + SOC | Experimental | Biological: BIOxHEAL (human amniotic membrane allograft)Participants randomized 2:1 to receive BIOxHEAL administered topically once weekly plus SOC for up to 12 weeks or until complete ulcer closure, with closure confirmed approximately 2 weeks later. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Participants must be at least 18 years of age or older. Participants must have a diagnosis of type 1 or 2 diabetes mellitus. At randomization (or enrollment for the sentinel cohort), participants must have a target ulcer with a minimum surface area of 1.0 cm2 and a maximum surface area of 25.0 cm2 measured post debridement.
- The target ulcer must have been present for a minimum of 4 weeks and a maximum of 52 weeks of standard of care prior to the initial screening visit.
- The target ulcer must be located on the foot with at least 50% of the ulcer below the malleolus.
- The target ulcer must be Wagner Grade 1 extending at least through the dermis or subcutaneous tissue.
- The affected limb must have adequate perfusion confirmed by vascular assessment. Any of the following methods performed within 3 months of the first screening visit are acceptable:
Key exclusion criteria (15 listed)
- Known life expectancy of less than 6 months. Target ulcer is not secondary to diabetes. Wagner Grade 2 to 5 ulcers. Target ulcer is infected, or there is cellulitis in the surrounding skin.
- Evidence of osteomyelitis complicating the target ulcer, based on clinical assessment supported by at least one of the following:
- Imaging (for example, plain radiography, MRI, or nuclear medicine study) consistent with osteomyelitis Positive bone culture Abnormal inflammatory markers (for example, ESR, CRP) in conjunction with clinical signs highly suggestive of osteomyelitis per Investigator judgment - Documentation of the basis for diagnosing or excluding osteomyelitis must be available in the participant's source documents Infection in the target ulcer or in a remote location that requires systemic antibiotic therapy.
- Receiving immunosuppressants (including systemic corticosteroids at doses greater than 10 mg of prednisone per day or equivalent) or cytotoxic chemotherapy.
- Topical application of steroids to the ulcer surface within one month of initial screening.
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 |
|---|---|---|
| Standard of CareProtocol-defined standard of care (SOC) for diabetic foot ulcers, performed at each study visit: wound cleansing with sterile saline, sharp debridement as clinically indicated, a non-adherent silicone primary dressing with an absorbent secondary dressing to maintain a moist wound environment, offloading for plantar and pressure-bearing ulcers (Foot Defender boot, Total Contact Cast, or Medical Monitor-approved equivalent), and diabetes education and nutritional support, including smoking cessation counseling for current smokers. | Other | Randomized: SOC Alone, Sentinel Cohort: BIOxHEAL + SOC |
| BIOxHEAL (human amniotic membrane allograft)BIOxHEAL is an investigational, sterile, single-use biologic derived from human amniotic membrane. BIOxHEAL is administered topically to the target ulcer once weekly in combination with protocol-defined standard of care for up to 12 weeks or until complete ulcer closure. Each unit is individually packaged for single-patient, one-time use. | Biological | Randomized: BIOxHEAL + SOC, Sentinel Cohort: BIOxHEAL + SOC |
Primary outcome
Proportion of target ulcers with complete wound closure at Week 12
Time frame: Baseline to Week 12
Complete closure is defined as 100% epithelialization, assessed by the Investigator and confirmed by blinded, independent wound evaluators. Compared between BIOxHEAL plus standard of care and standard of care alone.
5 secondary outcomes
Proportion of target ulcers with complete wound closure at Week 8
Time frame: Baseline to Week 8.
Proportion of participants with treatment-emergent adverse events (TEAEs), serious adverse events (SAEs) and adverse events of special interest (AESIs)
Time frame: From first treatment through the end of follow-up (at least 3 months after complete wound healing, or after Visit 13 if not healed), assessed up to approximately 6 months
Mean change in Wound Quality-of-Life (wQOL) score from baseline to Week 12
Time frame: Baseline to 12 weeks
Proportion of participants with major and minor lower extremity amputations, and number and frequency of amputations
Time frame: From first treatment through the end of the follow-up period, assessed up to approximately 6 months
Proportion of participants with completely closed diabetic foot ulcers at any time during the study
Time frame: From first treatment until complete wound closure (100% epithelialization) is first confirmed, assessed up to approximately 6 months
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 16 Oct 2026.
- Applied Biologics is a fully-integrated life sciences company providing research, product development, manufacturing and distribution of medical technologies. Since 2010, we've been dedicated to providing doctors innovative biologic solutions to deliverLink provided by the sponsor.
- Individual participant dataSharing planned: No. There is currently no plan to make individual participant data (IPD) available to other researchers. The Sponsor will consider reasonable requests for de-identified data after completion of the study and regulatory review, subject to participant privacy protections and applicable agreements.
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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.
Charles Zelen, DPM study director
Professional Education & Research Institute (PERI)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing BIOxHEAL (human amniotic membrane allograft) in people with Diabetic Foot Ulcer and Amniotic Membrane Placental Allograft, 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 10 inclusion and 15 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 16 Oct 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 susan A weins, RN (2505142586, susan.weins@appliedbiologics.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of target ulcers with complete wound closure at Week 12 (time frame: Baseline to Week 12). 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 16 Oct 2026.