Diabetic Foot Ulcers (DFUs)NCT06939673
Study of Miro3D Wound Matrix for Healing Wounds and Ulcers in Outpatient Care
A study testing Acellular Porcine-Derived Wound Matrix in people with Diabetic Foot Ulcers (DFUs) and Venous Leg Ulcers (VLUs), run by Reprise Biomedical, Inc. at 2 sites in United States.
Trial summary
This clinical study is being conducted to evaluate how well the Miro3D Wound Matrix helps heal difficult wounds and ulcerations in an outpatient care setting. Miro3D is a biologic wound dressing made from porcine (pig) liver tissue. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetic Foot Ulcers (DFUs), Venous Leg Ulcers (VLUs), Pressure Ulcers
- What is being tested?
- Acellular Porcine-Derived Wound Matrix
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 2 sitesUnited States
- Study dates
- 29 Feb 2024to 31 Dec 2025
- 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
- Age 18 or older and able to provide informed consent.
- Has an open wound or ulceration, preferably with tunneling or undermining.
- If multiple wounds/ulcerations are present, only one will be selected for Miro3D treatment.
- Other wounds must be ≥2 cm away from the study wound.
- Wound should be debrided with a clinical goal of healing, even if some infection remains.
- Previous infections must be adequately treated and controlled (per IDSA guidelines).
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- Willing and able to comply with offloading and/or compression requirements.
- Must have a stable living environment for wound care adherence.
- Study wound must have a clean base free of devitalized tissue or debris at the time of Miro3D placement.
- Provides consent for digital photo documentation.
Who cannot join
- Active, untreated osteomyelitis.
- Malignancy or vasculitis at the wound site.
- Undergoing chemotherapy.
- On dialysis.
- Use of investigational drugs or therapies within 30 days before screening.
- Conditions that significantly impair study adherence or known history of medical non-compliance.
Show all 12Show fewer
- Known sensitivity to porcine materials.
- Third-degree burns.
- Worsening ischemia or gangrene at screening.
- Prior radiation to the study wound site.
- Exposed hardware, implants, or fixation devices in the study wound.
- Receiving palliative or comfort care.
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
- Not yet recruiting
West Boca Center for Wound Healing
Coconut Creek, Florida, 33073
Eric J. Lullove, DPM, PA, 561-609-6473, drlullove@drlullove.com
Eric J. Lullove, DPM
- Recruiting
Barry University Clinical Research
Tamarac, Florida, 33321
Maria Swartz, 954-721-4806, mswartz@barry.edu
Cherison Cuffy, DPM
About this study
Official title: A Clinical Study of Reprise Biomedical's Miro3D Wound Matrix in the Outpatient Management of Wounds and Ulcerations
This clinical study is being conducted to evaluate how well the Miro3D Wound Matrix helps heal difficult wounds and ulcerations in an outpatient care setting. Miro3D is a biologic wound dressing made from porcine (pig) liver tissue. It is processed to remove all cells, creating a clean scaffold that can support the body's natural healing process. The goal of this study is to see how effective Miro3D is when used alongside standard wound care for helping wounds close and reducing pain and discomfort.
The study is designed as a post-market, proof-of-concept trial, meaning the product is already commercially available, and researchers are evaluating how it works in real-world clinical settings. A total of up to 20 adult participants will be enrolled. Participants may have wounds such as diabetic foot ulcers, venous leg ulcers, pressure ulcers, or surgical wound dehiscence. These wounds may be complex in nature, including tunneling or undermining, which often makes them more difficult to treat.
Read more
Participants will receive standard wound care along with weekly Miro3D applications for the first 4 weeks. If the wound is not fully healed after 4 weeks, Miro3D will then be applied every 2 weeks until healing is achieved or up to 12 weeks total. Throughout the study, participants will return weekly for wound assessments and to complete brief questionnaires about their pain levels and quality of life.
The main goals of the study are:
- To measure how much the wound size shrinks (known as percent area reduction or PAR).
- To evaluate how much healthy granulation tissue (new tissue) forms in the wound.
- To compare healing outcomes when Miro3D is used weekly versus every two weeks.
- To understand how the treatment affects patients' quality of life, including pain, mobility, and emotional wellbeing.
Each participant will be closely monitored by the clinical team throughout the 12-week study period. If a wound heals earlier, the participant will finish the study at that time. If the wound does not heal, the participant may return to their regular physician for follow-up care.
Read the detailed description
This clinical study is a prospective, post-market, proof-of-concept trial evaluating the safety and effectiveness of Miro3D Wound Matrix, a biologically derived, acellular scaffold developed by Reprise Biomedical, in the outpatient treatment of complex wounds and ulcerations. Miro3D is made from porcine liver tissue and processed to retain a porous, three-dimensional structure that provides a supportive environment for tissue regeneration.
The study investigates Miro3D's real-world impact on wound healing in adult subjects presenting with chronic or complex wounds, including but not limited to diabetic foot ulcers (DFUs), pressure ulcers, venous leg ulcers (VLUs), and surgical wound dehiscence (SWD). These types of wounds are often difficult to treat, particularly when they exhibit features like tunneling or undermining. The matrix is applied in conjunction with standard of care (SOC) therapies such as cleansing, offloading, compression, debridement, and the use of secondary dressings.
Up to 20 adult participants will be enrolled at outpatient clinical sites under the supervision of a principal investigator. The study includes both a screening phase and a 12-week treatment phase. There is no run-in or washout period. Eligible subjects are identified based on criteria including wound size (1-40 cm²), duration, location, vascular perfusion, and willingness to adhere to follow-up and offloading instructions. Subjects with third-degree burns, active untreated osteomyelitis, malignancy, or known porcine allergy, among other conditions, are excluded.
Each subject will receive Miro3D applied weekly for the first four weeks. If healing has not occurred at that point, Miro3D is reapplied every two weeks for up to twelve weeks or until the wound is fully closed. Wound healing is assessed weekly through manual measurements, photographs, and depth probing. The primary study endpoint is percentage area reduction (PAR) and granulation tissue formation at 4 and 12 weeks.
Secondary endpoints include changes from baseline in patient-reported quality of life (QOL) using the Wound-QOL questionnaire, and pain intensity assessed using a visual analog scale (VAS). These questionnaires are completed weekly to gauge the impact of treatment on physical function, emotional wellbeing, pain, odor, and social engagement. In the event of premature withdrawal, efforts are made to gather final QOL and pain assessments.
Subjects attend weekly study visits and may be seen for additional unscheduled visits at the investigator's discretion (e.g., for dressing changes). If the wound heals before 12 weeks, the subject exits the study. If the wound remains open, the subject exits after the final assessment and may return to their standard treating provider.
The study also closely monitors adverse events (AEs), serious adverse events (SAEs), and unanticipated adverse device effects (UADEs). Investigators assess each event's relationship to the study product and report them to the sponsor and IRB as required. All safety data are collected throughout the study and monitored by the study team and sponsor.
The data collected include subject demographics, medical and surgical history, wound type and size, infection status, tissue characteristics, exudate volume, and treatment regimen. These data are documented in source documents and transcribed into study-specific Case Report Forms (CRFs). Statistical analysis will be performed using summary statistics to evaluate wound closure rates, healing trajectories, and possible correlations between treatment schedule and healing outcomes.
As a post-market study, this trial does not require an Investigational Device Exemption (IDE) and is conducted in compliance with Good Clinical Practice (GCP), the Health Insurance Portability and Accountability Act (HIPAA), and FDA guidelines. It has been approved by an Institutional Review Board (IRB), and informed consent is required from all participants prior to enrollment.
By evaluating Miro3D in real-world outpatient conditions, this study aims to provide evidence on its ability to promote healing in challenging wounds. The findings may help guide future treatment approaches and inform larger clinical trials focused on specific wound types.
- Conditions
- Diabetic Foot Ulcers (DFUs), Venous Leg Ulcers (VLUs), Pressure Ulcers, Surgical Wound Dehiscence (SWD), Chronic Wounds, Undermined and Tunneling Wounds
- Being tested
- Acellular Porcine-Derived Wound Matrix
- Keywords
- Miro3D Wound Matrix, Acellular Wound Matrix, Porcine-Derived Scaffold, Chronic Wound Healing, Diabetic Foot Ulcer Treatment, Pressure Ulcer Management, Surgical Wound Dehiscence Therapy, Venous Leg Ulcer Treatment, Tunneling and Undermining Wounds, Complex Wound Management, Reprise Biomedical
- Medical subject headings
- Diabetic Foot, Pressure Ulcer, Surgical Wound Dehiscence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Acellular Porcine-Derived Wound MatrixDevice
Also called Miro3D Wound Matrix
This intervention is a sterile, acellular, three-dimensional biologic scaffold derived from porcine liver tissue using a proprietary perfusion decellularization and drying process. It retains the native extracellular matrix structure and supports tissue granulation and healing in complex wounds. Miro3D is applied topically to the debrided wound bed and rehydrated prior to use. It is indicated for use in a range of chronic and complex wounds, including diabetic foot ulcers, venous leg ulcers, pressure injuries, and surgical dehiscence. In this study, it is administered in an outpatient setting alongside standard of care treatments.
| Study group | Role | What they receive |
|---|---|---|
| Miro3D Wound Matrix plus Standard of Care (SOC) | Experimental | Participants in this single-arm study will receive Miro3D Wound Matrix in addition to standard wound care procedures. Miro3D is applied directly to the debrided wound bed. It will be applied once every 7 days for the first 4 weeks. If the wound has not closed by then, Miro3D will be applied every 14 days through week 12 or until wound closure, whichever comes first. Standard care includes debridement, dressing changes, offloading and/or compression, and infection management as needed. Weekly evaluations are performed to track healing progress. Receives: Device: Acellular Porcine-Derived Wound Matrix |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent Area Reduction (PAR) and Granulation Tissue Formation at 4 and 12 Weeks
The primary outcome is the measurement of the wound or ulcer's percent area reduction (PAR) and granulation tissue formation at week 4 and week 12. This is used to evaluate healing progression and the effectiveness of Miro3D. Measurements are taken using a ruler for length and width, and a probe for depth. Granulation is assessed visually by the clinical team.
Measured: 4 weeks and 12 weeks post-initial treatment
Secondary outcomes (2)
Change in Quality of Life (QOL) Using Wound-QOL Instrument
Subject-reported QOL will be assessed at each visit using the Wound-QOL questionnaire. This tool evaluates the impact of the wound on domains such as pain, odor, physical functioning, mobility, emotional wellbeing, and social isolation.
Measured: Baseline and weekly through 12 weeks or until wound closure
Change in Pain Levels Using Visual Analog Scale (VAS)
Pain intensity is assessed weekly using a 0-10 VAS, where 0 represents no pain and 10 represents the worst possible pain.
Measured: Baseline and weekly through 12 weeks or until wound closure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Apr 2025
- Study start29 Feb 2024
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- 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
- Not applicable
- Intervention model
- Single group
- Model description
- All enrolled participants will receive the same intervention: Miro3D Wound Matrix plus standard of care (SOC). There is no comparator or control arm. The study follows a single-arm, prospective design.
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Reprise Biomedical, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Robert J. Snyder, DPM, Principal investigator, Barry University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06939673
- Sponsor's protocol ID
- REPRISE001
- Other IDs
- 20240306
- Status last verified
- Dec 2025
- First submitted
- 15 Apr 2025
- Last updated
- 24 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Smith ME, Totten A, Hickam DH, Fu R, Wasson N, Rahman B, Motu'apuaka M, Saha S. Pressure ulcer treatment strategies: a systematic comparative effectiveness review. Ann Intern Med. 2013 Jul 2;159(1):39-50. doi: 10.7326/0003-4819-159-1-201307020-00007.
PubMed 23817703Raghav A, Khan ZA, Labala RK, Ahmad J, Noor S, Mishra BK. Financial burden of diabetic foot ulcers to world: a progressive topic to discuss always. Ther Adv Endocrinol Metab. 2018 Jan;9(1):29-31. doi: 10.1177/2042018817744513. Epub 2017 Dec 12.
PubMed 29344337Padula WV, Delarmente BA. The national cost of hospital-acquired pressure injuries in the United States. Int Wound J. 2019 Jun;16(3):634-640. doi: 10.1111/iwj.13071. Epub 2019 Jan 28.
PubMed 30693644Mervis JS, Phillips TJ. Pressure ulcers: Pathophysiology, epidemiology, risk factors, and presentation. J Am Acad Dermatol. 2019 Oct;81(4):881-890. doi: 10.1016/j.jaad.2018.12.069. Epub 2019 Jan 18.
PubMed 30664905Kruger EA, Pires M, Ngann Y, Sterling M, Rubayi S. Comprehensive management of pressure ulcers in spinal cord injury: current concepts and future trends. J Spinal Cord Med. 2013 Nov;36(6):572-85. doi: 10.1179/2045772313Y.0000000093. Epub 2013 May 21.
PubMed 24090179Geriatric Medicine Gerontology Chapter 30 - Pressure Ulcers. (n.d.). Retrieved from Johns Hopkins: https://www.hopkinsmedicine.org/geriatric_medicine_gerontology/_downloads/readings/section8.pdf
Bauer K, Rock K, Nazzal M, Jones O, Qu W. Pressure Ulcers in the United States' Inpatient Population From 2008 to 2012: Results of a Retrospective Nationwide Study. Ostomy Wound Manage. 2016 Nov;62(11):30-38.
PubMed 27861135
Study at a glance
From the registry record, last updated by the sponsor on 24 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Study of Reprise Biomedical's Miro3D Wound Matrix in the Outpatient Management of Wounds and Ulcerations
- ClinicalTrials.gov ID
- NCT06939673
- Acronym / sponsor ID
- REPRISE001
- Conditions
- Diabetic Foot Ulcers (DFUs), Venous Leg Ulcers (VLUs), Pressure Ulcers, Surgical Wound Dehiscence (SWD), Chronic Wounds, Undermined and Tunneling Wounds
- Keywords
- Miro3D Wound Matrix, Acellular Wound Matrix, Porcine-Derived Scaffold, Chronic Wound Healing, Diabetic Foot Ulcer Treatment, Pressure Ulcer Management, Surgical Wound Dehiscence Therapy, Venous Leg Ulcer Treatment
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Reprise Biomedical, Inc.Industry (pharma, biotech, devices)
- Study start
- 29 Feb 2024 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 23 Apr 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 clinical study is being conducted to evaluate how well the Miro3D Wound Matrix helps heal difficult wounds and ulcerations in an outpatient care setting. Miro3D is a biologic wound dressing made from porcine (pig) liver tissue. It is processed to remove all cells, creating a clean scaffold that can support the body's natural healing process. The goal of this study is to see how effective Miro3D is when used alongside standard wound care for helping wounds close and reducing pain and discomfort.
The study is designed as a post-market, proof-of-concept trial, meaning the product is already commercially available, and researchers are evaluating how it works in real-world clinical settings. A total of up to 20 adult participants will be enrolled. Participants may have wounds such as diabetic foot ulcers, venous leg ulcers, pressure ulcers, or surgical wound dehiscence. These wounds may be complex in nature, including tunneling or undermining, which often makes them more difficult to treat.
Participants will receive standard wound care along with weekly Miro3D applications for the first 4 weeks. If the wound is not fully healed after 4 weeks, Miro3D will then be applied every 2 weeks until healing is achieved or up to 12 weeks total. Throughout the study, participants will return weekly for wound assessments and to complete brief questionnaires about their pain levels and quality of life.
The main goals of the study are:
- To measure how much the wound size shrinks (known as percent area reduction or PAR).
- To evaluate how much healthy granulation tissue (new tissue) forms in the wound.
- To compare healing outcomes when Miro3D is used weekly versus every two weeks.
- To understand how the treatment affects patients' quality of life, including pain, mobility, and emotional wellbeing.
Each participant will be closely monitored by the clinical team throughout the 12-week study period. If a wound heals earlier, the participant will finish the study at that time. If the wound does not heal, the participant may return to their regular physician for follow-up care.
Detailed description
This clinical study is a prospective, post-market, proof-of-concept trial evaluating the safety and effectiveness of Miro3D Wound Matrix, a biologically derived, acellular scaffold developed by Reprise Biomedical, in the outpatient treatment of complex wounds and ulcerations. Miro3D is made from porcine liver tissue and processed to retain a porous, three-dimensional structure that provides a supportive environment for tissue regeneration.
The study investigates Miro3D's real-world impact on wound healing in adult subjects presenting with chronic or complex wounds, including but not limited to diabetic foot ulcers (DFUs), pressure ulcers, venous leg ulcers (VLUs), and surgical wound dehiscence (SWD). These types of wounds are often difficult to treat, particularly when they exhibit features like tunneling or undermining. The matrix is applied in conjunction with standard of care (SOC) therapies such as cleansing, offloading, compression, debridement, and the use of secondary dressings.
Up to 20 adult participants will be enrolled at outpatient clinical sites under the supervision of a principal investigator. The study includes both a screening phase and a 12-week treatment phase. There is no run-in or washout period. Eligible subjects are identified based on criteria including wound size (1-40 cm²), duration, location, vascular perfusion, and willingness to adhere to follow-up and offloading instructions. Subjects with third-degree burns, active untreated osteomyelitis, malignancy, or known porcine allergy, among other conditions, are excluded.
Each subject will receive Miro3D applied weekly for the first four weeks. If healing has not occurred at that point, Miro3D is reapplied every two weeks for up to twelve weeks or until the wound is fully closed. Wound healing is assessed weekly through manual measurements, photographs, and depth probing. The primary study endpoint is percentage area reduction (PAR) and granulation tissue formation at 4 and 12 weeks.
Secondary endpoints include changes from baseline in patient-reported quality of life (QOL) using the Wound-QOL questionnaire, and pain intensity assessed using a visual analog scale (VAS). These questionnaires are completed weekly to gauge the impact of treatment on physical function, emotional wellbeing, pain, odor, and social engagement. In the event of premature withdrawal, efforts are made to gather final QOL and pain assessments.
Subjects attend weekly study visits and may be seen for additional unscheduled visits at the investigator's discretion (e.g., for dressing changes). If the wound heals before 12 weeks, the subject exits the study. If the wound remains open, the subject exits after the final assessment and may return to their standard treating provider.
The study also closely monitors adverse events (AEs), serious adverse events (SAEs), and unanticipated adverse device effects (UADEs). Investigators assess each event's relationship to the study product and report them to the sponsor and IRB as required. All safety data are collected throughout the study and monitored by the study team and sponsor.
The data collected include subject demographics, medical and surgical history, wound type and size, infection status, tissue characteristics, exudate volume, and treatment regimen. These data are documented in source documents and transcribed into study-specific Case Report Forms (CRFs). Statistical analysis will be performed using summary statistics to evaluate wound closure rates, healing trajectories, and possible correlations between treatment schedule and healing outcomes.
As a post-market study, this trial does not require an Investigational Device Exemption (IDE) and is conducted in compliance with Good Clinical Practice (GCP), the Health Insurance Portability and Accountability Act (HIPAA), and FDA guidelines. It has been approved by an Institutional Review Board (IRB), and informed consent is required from all participants prior to enrollment.
By evaluating Miro3D in real-world outpatient conditions, this study aims to provide evidence on its ability to promote healing in challenging wounds. The findings may help guide future treatment approaches and inform larger clinical trials focused on specific wound types.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- All enrolled participants will receive the same intervention: Miro3D Wound Matrix plus standard of care (SOC). There is no comparator or control arm. The study follows a single-arm, prospective design.
| Arm | Type | Receives |
|---|---|---|
| Miro3D Wound Matrix plus Standard of Care (SOC) | Experimental | Device: Acellular Porcine-Derived Wound MatrixParticipants in this single-arm study will receive Miro3D Wound Matrix in addition to standard wound care procedures. Miro3D is applied directly to the debrided wound bed. It will be applied once every 7 days for the first 4 weeks. If the wound has not closed by then, Miro3D will be applied every 14 days through week 12 or until wound closure, whichever comes first. Standard care includes debridement, dressing changes, offloading and/or compression, and infection management as needed. Weekly evaluations are performed to track healing progress. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Age 18 or older and able to provide informed consent.
- Has an open wound or ulceration, preferably with tunneling or undermining.
- If multiple wounds/ulcerations are present, only one will be selected for Miro3D treatment.
- Other wounds must be ≥2 cm away from the study wound.
- Wound should be debrided with a clinical goal of healing, even if some infection remains.
Key exclusion criteria (12 listed)
- Active, untreated osteomyelitis.
- Malignancy or vasculitis at the wound site.
- Undergoing chemotherapy.
- On dialysis.
- Use of investigational drugs or therapies within 30 days before 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 |
|---|---|---|
| Acellular Porcine-Derived Wound MatrixAlso: Miro3D Wound MatrixThis intervention is a sterile, acellular, three-dimensional biologic scaffold derived from porcine liver tissue using a proprietary perfusion decellularization and drying process. It retains the native extracellular matrix structure and supports tissue granulation and healing in complex wounds. Miro3D is applied topically to the debrided wound bed and rehydrated prior to use. It is indicated for use in a range of chronic and complex wounds, including diabetic foot ulcers, venous leg ulcers, pressure injuries, and surgical dehiscence. In this study, it is administered in an outpatient setting alongside standard of care treatments. | Device | Miro3D Wound Matrix plus Standard of Care (SOC) |
Primary outcome
Percent Area Reduction (PAR) and Granulation Tissue Formation at 4 and 12 Weeks
Time frame: 4 weeks and 12 weeks post-initial treatment
The primary outcome is the measurement of the wound or ulcer's percent area reduction (PAR) and granulation tissue formation at week 4 and week 12. This is used to evaluate healing progression and the effectiveness of Miro3D. Measurements are taken using a ruler for length and width, and a probe for depth. Granulation is assessed visually by the clinical team.
2 secondary outcomes
Change in Quality of Life (QOL) Using Wound-QOL Instrument
Time frame: Baseline and weekly through 12 weeks or until wound closure
Change in Pain Levels Using Visual Analog Scale (VAS)
Time frame: Baseline and weekly through 12 weeks or until wound closure
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 24 Dec 2025.
- Background: PubMed 23817703Smith ME, Totten A, Hickam DH, Fu R, Wasson N, Rahman B, Motu'apuaka M, Saha S. Pressure ulcer treatment strategies: a systematic comparative effectiveness review. Ann Intern Med. 2013 Jul 2;159(1):39-50. doi: 10.7326/0003-4819-159-1-201307020-00007.
- Background: PubMed 29344337Raghav A, Khan ZA, Labala RK, Ahmad J, Noor S, Mishra BK. Financial burden of diabetic foot ulcers to world: a progressive topic to discuss always. Ther Adv Endocrinol Metab. 2018 Jan;9(1):29-31. doi: 10.1177/2042018817744513. Epub 2017 Dec 12.
- Background: PubMed 30693644Padula WV, Delarmente BA. The national cost of hospital-acquired pressure injuries in the United States. Int Wound J. 2019 Jun;16(3):634-640. doi: 10.1111/iwj.13071. Epub 2019 Jan 28.
- Background: PubMed 30664905Mervis JS, Phillips TJ. Pressure ulcers: Pathophysiology, epidemiology, risk factors, and presentation. J Am Acad Dermatol. 2019 Oct;81(4):881-890. doi: 10.1016/j.jaad.2018.12.069. Epub 2019 Jan 18.
- Background: PubMed 24090179Kruger EA, Pires M, Ngann Y, Sterling M, Rubayi S. Comprehensive management of pressure ulcers in spinal cord injury: current concepts and future trends. J Spinal Cord Med. 2013 Nov;36(6):572-85. doi: 10.1179/2045772313Y.0000000093. Epub 2013 May 21.
- BackgroundGeriatric Medicine Gerontology Chapter 30 - Pressure Ulcers. (n.d.). Retrieved from Johns Hopkins: https://www.hopkinsmedicine.org/geriatric_medicine_gerontology/_downloads/readings/section8.pdf
- Background: PubMed 27861135Bauer K, Rock K, Nazzal M, Jones O, Qu W. Pressure Ulcers in the United States' Inpatient Population From 2008 to 2012: Results of a Retrospective Nationwide Study. Ostomy Wound Manage. 2016 Nov;62(11):30-38.
- Miro3D Wound Matrix product webpageLink provided by the sponsor.
- 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.
Robert J. Snyder, DPM principal investigator
Barry University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Acellular Porcine-Derived Wound Matrix in people with Diabetic Foot Ulcers (DFUs) and Venous Leg Ulcers (VLUs), run by Reprise Biomedical, Inc. 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 10 inclusion and 12 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 24 Dec 2025. 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.
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 Maria Swartz (954-721-4806, mswartz@barry.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percent Area Reduction (PAR) and Granulation Tissue Formation at 4 and 12 Weeks (time frame: 4 weeks and 12 weeks post-initial treatment). 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 NCT06939673, which also lists 7 linked publications.
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 24 Dec 2025.