An interventional study of Acellular Porcine-Derived Wound Matrix in Diabetic Foot Ulcers (DFUs), Venous Leg Ulcers (VLUs) and Pressure Ulcers, sponsored by Reprise Biomedical, Inc.. Recruiting at 2 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-12-24.
Sponsored by Reprise Biomedical, Inc. · Not applicable, Interventional, and Treatment
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Among 381 studies in Diabetic Foot with a site in United States — 66 open to participants now, 85 under way, 3 of them phase 3. Diabetic Foot · United States.
Among the 381 studies in Diabetic Foot with a site in United States, this one is the 250th largest by planned enrollment of the 322 interventional ones that give a count, is one of 33 that started in 2024, is one of 186 with no phase, reaches primary completion later than 15 of the 84 other live ones, and was the 344th registered.
1,078 studies on the registry are indexed under Diabetic Foot; 222 are open to participants now.
Browse Diabetic Foot studies →66 of the 381 studies in Diabetic Foot with a site in United States are open now. Recruiting first, the newest first:
Applied Biologics, LLC · Sites in United States
Ages 18+
Biodynamik, Inc · Sites in United States
Ages 22+
Lakewood-Amedex Inc · Sites in United States
Ages 18+
Capsicure, LLC · Sites in United States
Ages 18+
Reprise Biomedical, Inc. · Sites in United States
Ages 18+
A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →
Of the 137 Diabetic Foot studies recruiting now, 96 (70%) set no upper age limit and 12 (9%) stop at 75 or younger; 5 take children under 18; 10 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
381 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 25 · Phase 2 54 · Phase 3 37 · Phase 4 31
First in 1994; this study’s year is marked. 33 started in 2024.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 20 is below the median of 60 across 848 interventional studies indexed under Diabetic Foot.
Median enrollment 60 across the 322 interventional studies, 138 across the 58 observational. Of the 249 that completed or were terminated, 89 (36%) have results posted.
This tab as a report to print or save as PDF → With an account.
253 of 381 have an industry lead sponsor. The 10 most frequent:
Reprise Biomedical, Inc. is the lead sponsor of 3 studies on the registry; 3 are open to participants now.
Reprise Biomedical, Inc. has 3 studies filed under Diabetic Foot — fewer than ten, so there is no comparison to draw.
34 of the studies in Diabetic Foot with a site in United States that are under way reach primary completion within a year, 2 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT05369052Phase 3MicuRxSafety and Efficacy Study of Contezolid Acefosamil and Contezolid Compared to Linezolid Administered Intravenously and Orally to Adults With Moderate or Severe Diabetic Foot Infections (DFI) | 2027-06-30 |
| NCT07852338Phase 3Applied Biologics, LLCa 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 | 2027-09 |
| NCT06420245Legacy Medical ConsultantsClinical Utility of an Amniotic Membrane Allograft for Diabetic Foot Ulcer Wound Management | 2026-11 |
| NCT06449638StimLabsModified Platform Trial Assessing Multiple CAMPs and SOC vs SOC Alone in the Treatment of Hard-to-Heal DFUs | 2026-11 |
| NCT06681428Tides MedicalRising Tide - Amniotic Tissue(s) Treatments for Chronic Diabetic Foot Ulcers | 2026-11-18 |
Add all 34 to your calendar (.ics) → With an account.
Among the 381 studies in Diabetic Foot with a site in United States, from their registry updates:
This tab as a report to print or save as PDF → With an account.
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:
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.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Device: Acellular Porcine-Derived 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.
Also known as: Miro3D Wound Matrix
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.
Time frame: 4 weeks and 12 weeks post-initial treatment
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.
Time frame: 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.
Time frame: Baseline and weekly through 12 weeks or until wound closure
Safety and Tolerability: Adverse Events (AEs), Serious Adverse Events (SAEs), and Unanticipated Adverse Device Effects (UADEs)
The frequency and severity of adverse events, including product-related effects such as inflammation, irritation, or infection, will be recorded. Events will be assessed for seriousness, expectedness, and relatedness to the investigational product.
Time frame: From informed consent through 30 days after final study visit
Plan to share: No
Started Feb 2024 (actual). Primary completion is estimated for Dec 2025, 22 months after the start.
Of 103 industry-sponsored interventional studies with no phase under Diabetic Foot, half reached primary completion within 25 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 40. This study's planned 22 months is below that.
Counting every sponsor, half of 343 studies reached it within 22 months; a quarter within 9 and three quarters within 39.
How these figures are worked out, and which studies are left out of them.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
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Reprise Biomedical, Inc.