Diabetic Foot Ulcers (DFUs)FOCUS 3DNCT07632001
Miro3D Wound Matrix for Treatment of Diabetic Foot Ulcers
A study testing Miro3D Wound Matrix in people with Diabetic Foot Ulcers (DFUs) and Diabetic Foot, run by Reprise Biomedical, Inc. at 14 sites in United States.
Trial summary
This study is designed to evaluate whether the Miro3D Wound Matrix, when used in addition to standard of care, improves healing outcomes in patients with chronic diabetic foot ulcers. Diabetic foot ulcers are a common and serious complication of diabetes and may be difficult to heal despite appropriate treatment. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetic Foot Ulcers (DFUs), Diabetic Foot, Chronic Wounds
- What is being tested?
- Miro3D Wound Matrix
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- 14 sitesUnited States
- Study dates
- 15 Jun 2026to May 2027
- Phase
- Interventional
- 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
- Subjects 18 years of age or older.
- Subject history of Type I or Type II Diabetes Mellitus requiring treatment with oral medications and/or insulin replacement therapy.
- 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.
- Objectively, less than 25% wound area reduction 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.
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- The subject is able and willing to follow the protocol requirements.
- Subject has signed informed consent.
- Subjects with the following ulcer:
- Presence of a diabetic foot ulcer Wagner 1 or 2 grade at the first screening visit on any aspect of the foot, provided 50% of the wound sits below the level of the malleolus. This includes DFUs as a result of open amputation sites and surgical wound dehiscence as long as all other criteria are met. [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 2 cm distant apart.]
- 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; Toe pressures >50mmHg; an ABI between 0.7 and ≤ 1.3, or TBI of >0.6 within 3 months of the first Screening Visit.
- 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 pills, barriers, or abstinence) starting at Screening and continuing through the duration of their study participation.
- 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).
- The index ulcer has a clean base and is free of necrotic debris at time of placement of treatment product.
Who cannot join
- 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 < 25% 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 acellular dermal matrices or known allergies to any of the Miro3D 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 ≥25% 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) including any other CAMP within the last 30 days preceding the first treatment visit.
- Affected extremity requiring hyperbaric oxygen during the trial or within 2 weeks of screening visit 1.
- Presence of diabetes with poor metabolic control as documented with an HbA1c ≥12.0 within 30 days of randomization (TV1).
- Index ulcer and/or index limb with presence of gangrene or unstable ischemia at screening (SV1).
- Revascularization surgery on the lower extremity on which the index ulcer is located within 30 days of Screening Visit (SV1).
- Index ulcer in the opinion of the Principal Investigator, is suspicious for cancer and should undergo an ulcer biopsy to rule out a neoplasm of the ulcer.
- Any clinically significant finding, in the judgment of the Principal Investigator, that would place the subject at health risk, impact the study, or affect the completion of the study.
Trial locations and contacts
14 sites in 1 country. Contact the study team or a site near you to ask about taking part.
14 sites in 1 country
United States14 sites, 14 recruiting
- Not yet recruiting
West Boca Center for Wound Healing
Coconut Creek, Florida, 33073
Eric Lullove, 561-989-9780, drlullove@drlullove.com
Eric Lullove
- Recruiting
ABC Podiatry
Columbus, Ohio, 43213
Lyndsie Walker, 614-755-2290, lwalker@abcpodiatry.com
Richard Schilling
- Recruiting
Solutions Medical Research
Coral Gables, Florida, 33134
Leandro Pena, 305-425-1238, sitedirector@solutionsmedicalresearch.com
Francisco J Oliva
- Recruiting
Caring Foot and Ankle Specialists
Houston, Texas, 77035
Jerry Bellamy, 713-517-5176, jerry.bellamy@haloclinicalresearch.com
Gian Steinhauser
- Recruiting
Vital Heart and Vein
Humble, Texas, 77338
Jerry Bellamy, 713-517-5176, jerry.bellamy@haloclinicalresearch.com
Kent Jarvis
- Not yet recruiting
Clinical Trials of New England
Hyde Park, Massachusetts, 02136
Kenny Carberry, 617-827-1803, kcarberry@clinicaltrialsne.com
Michael Lowney
- Not yet recruiting
Doctors Research Network
Miami, Florida, 33156
Maria Surprenant, 305-665-3017, msurprenant@drnmiami.com
Maria Surprenant
- Not yet recruiting
Icahn School of Medicine at Mount Sinai
New York, New York, 10029
Garismar Ramirez, 212-523-6905, Garismar.Ramirez@mountsinai.org
John Lantis
- Not yet recruiting
Dynamic Wound Care
Oklahoma City, Oklahoma, 73159
Jerry Bellamy, 713-517-5176, jerry.bellamy@haloclinicalresearch.com
Alex Cralley
- Recruiting
Advanced Foot Care
Phoenix, Arizona, 85032
Krishna S Penumarthi, 857-891-3039, krishnap@advancedfootcareusa.com
Jaminelli Banks
- Not yet recruiting
Mercy Hyperbaric and Wound Care
St Louis, Missouri, 63128
Preeti Srivastava, 314-251-7712, preeti.srivastava@mercy.net
Amy Couch
- Not yet recruiting
St. Louis Foot & Ankle
St Louis, Missouri, 63128
Bonnie Weiss, 314-596-9670, blsweiss.practicemanager@gmail.com
Raymond Abdo
- Not yet recruiting
Christian Hospital Wound Center
St Louis, Missouri, 63136
Christine Kuehnel, 314-362-5298, ckuehnel@wustl.edu
Bradley Freeman
- Recruiting
Barry University
Tamarac, Florida, 33321
Maria Swartz, 954-721-4806, mswartz@barry.edu
Cherison Cuffy
About this study
Official title: A Randomized Controlled Multicenter Trial, Examining the Effect of Miro3D Wound Matrix on the Rate of Complete Wound Closure of Chronic Diabetic Foot Ulcers
This study is designed to evaluate whether the Miro3D Wound Matrix, when used in addition to standard of care, improves healing outcomes in patients with chronic diabetic foot ulcers.
Diabetic foot ulcers are a common and serious complication of diabetes and may be difficult to heal despite appropriate treatment. Standard of care typically includes regular wound cleaning, debridement (removal of dead tissue), offloading (reducing pressure on the wound), and moisture-balancing dressings. However, some wounds fail to heal with standard treatment alone.
Read more
Miro3D Wound Matrix is a three-dimensional, acellular scaffold derived from porcine tissue that is intended to support wound healing. This study will compare outcomes in patients treated with Miro3D plus standard of care versus standard of care alone.
Approximately 180 adult subjects with non-healing diabetic foot ulcers will be enrolled at multiple clinical sites in the United States. After a two-week screening period, eligible participants will be randomly assigned to receive either Miro3D in addition to standard of care or standard of care alone. Subjects will be followed for up to 12 weeks with weekly clinic visits.
The primary objective of the study is to determine whether treatment with Miro3D increases the rate of complete wound closure and improves reduction in wound size compared to standard of care alone. Safety will also be evaluated by monitoring adverse events throughout the study.
Read the detailed description
This is a prospective, multicenter, open-label, randomized controlled trial designed to evaluate the safety and effectiveness of the Miro3D Wound Matrix in the treatment of chronic, non-healing diabetic foot ulcers (DFUs).
Diabetic foot ulcers represent a significant clinical and economic burden and are associated with increased risk of infection, hospitalization, and amputation. Despite adherence to standard of care (SOC), including offloading, debridement, infection control, and moisture management, a substantial proportion of DFUs fail to achieve complete healing. This study aims to assess whether adjunctive treatment with Miro3D Wound Matrix can improve healing outcomes compared to SOC alone.
Miro3D Wound Matrix is a sterile, acellular, three-dimensional scaffold derived from porcine liver tissue. The matrix is designed to provide a structural environment that supports tissue regeneration and wound healing. The product is applied topically to the wound following appropriate wound bed preparation.
Approximately 180 adult subjects with Wagner Grade 1 or 2 diabetic foot ulcers will be enrolled across up to 20 clinical sites in the United States. Subjects must have ulcers present for at least 4 weeks but less than 12 months and must demonstrate less than 25% reduction in wound area during a two-week screening period under standard of care.
Following screening, eligible subjects will be randomized in a 1:1 ratio to one of two treatment arms: treatment with Miro3D Wound Matrix in addition to standard of care, or standard of care alone.
Standard of care will include sharp debridement, offloading using a protocol-defined device, and appropriate moisture-retentive dressings.
Subjects will be evaluated at weekly intervals for up to 12 weeks. At each visit, assessments will include wound measurement, photographic documentation, infection status, pain assessment using the Numeric Pain Rating Scale (NPRS), and monitoring of adverse events. At select sites, additional exploratory imaging assessments may be performed, including near-infrared tissue oxygenation and fluorescence imaging.
The primary endpoints of the study are complete wound closure at 12 weeks, defined as full re-epithelialization without drainage or need for dressing, with closure confirmed at a single healing confirmation visit conducted two weeks after complete closure is initially documented, and percentage area reduction of the target ulcer over the study period. Secondary endpoints include change in pain associated with the ulcer and the incidence and frequency of adverse events. Exploratory endpoints will assess spatial and temporal changes in tissue oxygenation and fluorescence imaging characteristics at technology-enabled sites.
The study will use a Bayesian adaptive statistical framework, incorporating prior information and observed data to estimate treatment effects. Interim analyses may be conducted to evaluate efficacy, safety, and sample size assumptions.
This study is intended to generate clinical evidence supporting the use of Miro3D Wound Matrix as an adjunctive therapy for improving healing outcomes in patients with chronic diabetic foot ulcers.
- Conditions
- Diabetic Foot Ulcers (DFUs), Diabetic Foot, Chronic Wounds
- Being tested
- Miro3D Wound Matrix, Standard of Care
- Keywords
- Miro3D, Wound Matrix, Extracellular Matrix, Acellular Dermal Matrix, Diabetic Foot Ulcer, Chronic Wound Healing, Advanced Wound Care, Randomized Controlled Trial, Wound Closure, Tissue Regeneration, Offloading, Debridement
- Medical subject headings
- Diabetic Foot
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Miro3D Wound MatrixDevice
Miro3D Wound Matrix is a sterile, acellular, three-dimensional scaffold derived from porcine liver tissue and applied topically to the wound following appropriate wound bed preparation to support tissue regeneration and healing.
Standard of CareOther
Standard of care includes sharp debridement, offloading using a protocol-defined device, and appropriate moisture-retentive dressings.
| Study group | Role | What they receive |
|---|---|---|
| Miro3D Wound Matrix Plus Standard of Care | Experimental | Participants will receive Miro3D Wound Matrix in addition to standard of care, including sharp debridement, offloading using a protocol-defined device, and appropriate moisture-retentive dressings. Receives: Device: Miro3D Wound Matrix; Other: Standard of Care |
| Standard of Care Alone | Active comparator | Participants will receive standard of care alone, including sharp debridement, offloading using a protocol-defined device, and appropriate moisture-retentive dressings. Receives: Other: Standard of Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of Participants Achieving Complete Wound Closure of the Target Diabetic Foot Ulcer at 12 Weeks
Complete wound closure is defined as full re-epithelialization of the target ulcer without drainage or need for dressing, with closure confirmed at a single healing confirmation visit conducted approximately two weeks after complete closure is initially documented.
Measured: Up to 12 weeks
Mean Percentage Reduction in Target Ulcer Surface Area From Baseline to 12 Weeks
Percentage area reduction (PAR) is defined as the percent change in surface area of the target ulcer from baseline, as measured by digital planimetry.
Measured: Baseline through 12 weeks
Secondary outcomes (2)
Mean Change From Baseline in Ulcer-Associated Pain Score Assessed by Numeric Pain Rating Scale (NPRS)
Ulcer-associated pain will be assessed using the Numeric Pain Rating Scale (NPRS), a patient-reported scale ranging from 0 (no pain) to 10 (worst possible pain).
Measured: Baseline through 12 weeks
Number of Participants Experiencing Treatment-Emergent Adverse Events
Treatment-emergent adverse events will be collected and coded throughout the study period and summarized by treatment group.
Measured: Up to 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 Jun 2026
- Study start15 Jun 2026
- Primary completionMar 2027 (estimated)
- Study completionMay 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 Ulcers (DFUs)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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomized in a 1:1 ratio to receive either Miro3D Wound Matrix in addition to standard of care or standard of care alone, with both groups followed concurrently for evaluation of wound healing outcomes over a 12-week treatment period.
- Masking
- None (open label)
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Reprise Biomedical, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07632001
- Sponsor's protocol ID
- RB-FOCUS3D-DFU
- Other IDs
- IRB Tracking Number: 20261327
- Acronym
- FOCUS 3D
- Status last verified
- Aug 2026
- First submitted
- 15 May 2026
- Last updated
- 13 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided: At this time, the sponsor has not made a final determination regarding the sharing of individual participant data. Any future decision to share de-identified data will be made in accordance with applicable regulatory requirements, data privacy considerations, and sponsor policies, and may depend on the nature of future scientific collaborations and publication plans.
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Multicenter Trial, Examining the Effect of Miro3D Wound Matrix on the Rate of Complete Wound Closure of Chronic Diabetic Foot Ulcers
- ClinicalTrials.gov ID
- NCT07632001
- Acronym / sponsor ID
- FOCUS 3D / RB-FOCUS3D-DFU
- Conditions
- Diabetic Foot Ulcers (DFUs), Diabetic Foot, Chronic Wounds
- Keywords
- Miro3D, Wound Matrix, Extracellular Matrix, Acellular Dermal Matrix, Diabetic Foot Ulcer, Chronic Wound Healing, Advanced Wound Care, Randomized Controlled Trial
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- Reprise Biomedical, Inc.Industry (pharma, biotech, devices)
- Study start
- 15 Jun 2026 (actual)
- Primary completion
- Mar 2027 (estimated)
- Study completion
- May 2027 (estimated)
- First posted
- 8 Jun 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.
This study is designed to evaluate whether the Miro3D Wound Matrix, when used in addition to standard of care, improves healing outcomes in patients with chronic diabetic foot ulcers.
Diabetic foot ulcers are a common and serious complication of diabetes and may be difficult to heal despite appropriate treatment. Standard of care typically includes regular wound cleaning, debridement (removal of dead tissue), offloading (reducing pressure on the wound), and moisture-balancing dressings. However, some wounds fail to heal with standard treatment alone.
Miro3D Wound Matrix is a three-dimensional, acellular scaffold derived from porcine tissue that is intended to support wound healing. This study will compare outcomes in patients treated with Miro3D plus standard of care versus standard of care alone.
Approximately 180 adult subjects with non-healing diabetic foot ulcers will be enrolled at multiple clinical sites in the United States. After a two-week screening period, eligible participants will be randomly assigned to receive either Miro3D in addition to standard of care or standard of care alone. Subjects will be followed for up to 12 weeks with weekly clinic visits.
The primary objective of the study is to determine whether treatment with Miro3D increases the rate of complete wound closure and improves reduction in wound size compared to standard of care alone. Safety will also be evaluated by monitoring adverse events throughout the study.
Detailed description
This is a prospective, multicenter, open-label, randomized controlled trial designed to evaluate the safety and effectiveness of the Miro3D Wound Matrix in the treatment of chronic, non-healing diabetic foot ulcers (DFUs).
Diabetic foot ulcers represent a significant clinical and economic burden and are associated with increased risk of infection, hospitalization, and amputation. Despite adherence to standard of care (SOC), including offloading, debridement, infection control, and moisture management, a substantial proportion of DFUs fail to achieve complete healing. This study aims to assess whether adjunctive treatment with Miro3D Wound Matrix can improve healing outcomes compared to SOC alone.
Miro3D Wound Matrix is a sterile, acellular, three-dimensional scaffold derived from porcine liver tissue. The matrix is designed to provide a structural environment that supports tissue regeneration and wound healing. The product is applied topically to the wound following appropriate wound bed preparation.
Approximately 180 adult subjects with Wagner Grade 1 or 2 diabetic foot ulcers will be enrolled across up to 20 clinical sites in the United States. Subjects must have ulcers present for at least 4 weeks but less than 12 months and must demonstrate less than 25% reduction in wound area during a two-week screening period under standard of care.
Following screening, eligible subjects will be randomized in a 1:1 ratio to one of two treatment arms: treatment with Miro3D Wound Matrix in addition to standard of care, or standard of care alone.
Standard of care will include sharp debridement, offloading using a protocol-defined device, and appropriate moisture-retentive dressings.
Subjects will be evaluated at weekly intervals for up to 12 weeks. At each visit, assessments will include wound measurement, photographic documentation, infection status, pain assessment using the Numeric Pain Rating Scale (NPRS), and monitoring of adverse events. At select sites, additional exploratory imaging assessments may be performed, including near-infrared tissue oxygenation and fluorescence imaging.
The primary endpoints of the study are complete wound closure at 12 weeks, defined as full re-epithelialization without drainage or need for dressing, with closure confirmed at a single healing confirmation visit conducted two weeks after complete closure is initially documented, and percentage area reduction of the target ulcer over the study period. Secondary endpoints include change in pain associated with the ulcer and the incidence and frequency of adverse events. Exploratory endpoints will assess spatial and temporal changes in tissue oxygenation and fluorescence imaging characteristics at technology-enabled sites.
The study will use a Bayesian adaptive statistical framework, incorporating prior information and observed data to estimate treatment effects. Interim analyses may be conducted to evaluate efficacy, safety, and sample size assumptions.
This study is intended to generate clinical evidence supporting the use of Miro3D Wound Matrix as an adjunctive therapy for improving healing outcomes in patients with chronic diabetic foot ulcers.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants will be randomized in a 1:1 ratio to receive either Miro3D Wound Matrix in addition to standard of care or standard of care alone, with both groups followed concurrently for evaluation of wound healing outcomes over a 12-week treatment period.
| Arm | Type | Receives |
|---|---|---|
| Miro3D Wound Matrix Plus Standard of Care | Experimental | Device: Miro3D Wound Matrix, Other: Standard of CareParticipants will receive Miro3D Wound Matrix in addition to standard of care, including sharp debridement, offloading using a protocol-defined device, and appropriate moisture-retentive dressings. |
| Standard of Care Alone | Active comparator | Other: Standard of CareParticipants will receive standard of care alone, including sharp debridement, offloading using a protocol-defined device, and appropriate moisture-retentive dressings. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Subjects 18 years of age or older.
- Subject history of Type I or Type II Diabetes Mellitus requiring treatment with oral medications and/or insulin replacement therapy.
- 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.
- Objectively, less than 25% wound area reduction 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.
Key exclusion criteria (21 listed)
- 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 < 25% 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 |
|---|---|---|
| Miro3D Wound MatrixMiro3D Wound Matrix is a sterile, acellular, three-dimensional scaffold derived from porcine liver tissue and applied topically to the wound following appropriate wound bed preparation to support tissue regeneration and healing. | Device | Miro3D Wound Matrix Plus Standard of Care |
| Standard of CareStandard of care includes sharp debridement, offloading using a protocol-defined device, and appropriate moisture-retentive dressings. | Other | Miro3D Wound Matrix Plus Standard of Care, Standard of Care Alone |
Primary outcome
Proportion of Participants Achieving Complete Wound Closure of the Target Diabetic Foot Ulcer at 12 Weeks
Time frame: Up to 12 weeks
Complete wound closure is defined as full re-epithelialization of the target ulcer without drainage or need for dressing, with closure confirmed at a single healing confirmation visit conducted approximately two weeks after complete closure is initially documented.
Mean Percentage Reduction in Target Ulcer Surface Area From Baseline to 12 Weeks
Time frame: Baseline through 12 weeks
Percentage area reduction (PAR) is defined as the percent change in surface area of the target ulcer from baseline, as measured by digital planimetry.
2 secondary outcomes
Mean Change From Baseline in Ulcer-Associated Pain Score Assessed by Numeric Pain Rating Scale (NPRS)
Time frame: Baseline through 12 weeks
Number of Participants Experiencing Treatment-Emergent Adverse Events
Time frame: Up to 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 13 Aug 2026.
- Individual participant dataSharing planned: Undecided. At this time, the sponsor has not made a final determination regarding the sharing of individual participant data. Any future decision to share de-identified data will be made in accordance with applicable regulatory requirements, data privacy considerations, and sponsor policies, and may depend on the nature of future scientific collaborations and publication plans.
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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.
14 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Miro3D Wound Matrix in people with Diabetic Foot Ulcers (DFUs) and Diabetic Foot, run by Reprise Biomedical, Inc. at 14 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 21 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 13 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 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?
Contact Erin Badali (763-284-6785, ebadali@reprisebio.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of Participants Achieving Complete Wound Closure of the Target Diabetic Foot Ulcer at 12 Weeks (time frame: Up to 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 13 Aug 2026.