WoundNCT07347106
Miro3D Randomized Controlled Trial (RCT)
A study of Wound, run by Washington University School of Medicine at 1 site in United States.
Trial summary
The purpose of this research study is to evaluate the outcomes for patients managed with standard of care (SOC) wound treatments and those managed with standard of care treatment and tissue scaffolds, specifically Miro 3D. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Wound
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Nov 2025to Jul 2028
- 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 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects must fulfill all the following inclusion criteria to qualify for enrollment:
- Men or women 18-90 years of age at enrollment.
- Ability to sign consent by subject or LAR.
- Wounds in one of the two arms:
- A. Soft tissue wounds with a minimum size of 1 cm x 1 cm surface area and a maximum size of 40 cm L x 20 cm W x 5 cm D, resulting from either post-fasciotomy or post-NSSTI, including the pelvis with the lower extremity. Fasciotomies must have undergone complete debridement and, in the opinion of a trial investigator, be appropriate for wound healing but not ready for primary closure at randomization.
- B. Chronic, complex pressure ulcers classified as Stage III or higher, located in the decubitus or ischial region, that have not achieved at least a 50% reduction in ulcer area despite receiving documented SOC treatment for a minimum of four (4) weeks, with confirmed patient compliance.
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- Subjects must agree to proper offloading and/or compression of the wound or ulcer throughout the trial.
- Written informed consent is required for digital photo imaging.
- For the Miro3D plus SOC arm, the wound or ulcer must have a clean base that is free of devitalized tissue or debris at the time of Miro3D placement.
- Subjects receiving NPWT at baseline are eligible for enrollment. The use of NPWT during the trial will be at the discretion of the treating provider.
Who cannot join
- Subjects who meet any of the following criteria will be excluded from trial participation:
- The PAR of the pressure ulcer arm has reduced by 50% or more after four (4) weeks of SOC.
- Wounds with active invasive infection not yet controlled in the opinion of a trial investigator.
- Wounds with vascular insufficiencies requiring revascularization.
- Trial investigator deems the subject has no meaningful wound healing potential (e.g., advanced cancer, severe malnutrition) and/or has conditions that seriously compromise the subject's ability to complete the trial or a known history of non-adherence to medical care.
- Undergoing chemotherapy.
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- History of radiation to the area of the index wound or ulcer, regardless of time since last radiation treatment.
- Use of investigational drugs or therapies within thirty (30) days before screening.
- On dialysis.
- Sensitivity, allergy, or contraindication to Miro3D and/or NPWT or its components.
- Presence of third-degree burns.
- Index wound or ulcer exhibiting worsening ischemia or gangrene at screening.
- Subjects moving toward palliative or comfort care.
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
Washington University School of Medicine
St Louis, Missouri, 63110
John Kirby, M.D., 314-747-0556, kirbyj@wustl.edu
Aaron Day, RN, BSN, 3143628041, aaronday@wustl.edu
About this study
Official title: A Prospective, Randomized Controlled Trial of Miro3D Wound Matrix With Standard of Care Versus Standard of Care Alone in Treating Acute Soft Tissue Wounds and Chronic Pressure Ulcerations
The purpose of this research study is to evaluate the outcomes for patients managed with standard of care (SOC) wound treatments and those managed with standard of care treatment and tissue scaffolds, specifically Miro 3D. Tissue scaffolds like Miro 3D are 3-dimentional frameworks for collagen protein that provide structure and protection to help wounds heal.
Read the detailed description
Acellular tissue scaffolds, such as Miro3D, were developed to aid in the management of complex tissue defect wounds and ulcerations by providing a structural matrix that supports cellular infiltration and tissue regeneration. However, high-quality prospective data remain limited, particularly regarding soft tissue deficits and pressure ulcerations. This prospective RCT is designed to evaluate the efficacy and outcomes of subjects randomized to receive either SOC alone or SOC with the addition of tissue scaffolding techniques (Miro3D) over a twelve (12)-week timeframe.
The trial will investigate two categories of complex wounds: soft tissue wounds, including post-fasciotomy wounds and wounds resulting from necrotizing skin and soft tissue infection (NSSTI), and chronic pressure ulcerations, with a focus on decubitus and ischial pressure ulcers. The trial aims to generate real-world data, including cost-effectiveness parameters, and features a crossover arm to evaluate the impact of delayed wound bed preparation and the application of tissue scaffolds.
Additionally, the trial will evaluate healing quality using digital wound photography and mathematical analysis of wound redness as a surrogate marker for granulation tissue formation. Time to hospital discharge will also be tracked for acute wounds to assess cost and resource utilization. By analyzing the effectiveness of Miro3D in combination with SOC, this trial seeks to provide meaningful insights into optimizing wound management strategies.
- Conditions
- Wound
- Being tested
- Standard of Care Treatment or Standard of Care Treatment plus Miro3D Wound Matrix
- Medical subject headings
- Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard of Care Treatment or Standard of Care Treatment plus Miro3D Wound MatrixOther
Subjects with lower extremity three-dimensional tissue defects, including those resulting from elevated calf intra-compartmental hypertension treated with decompressive fasciotomies or serious NSSTIs of the foot or lower extremities (including the pelvis as part of the lower extremity). These defects must have been controlled with surgical debridement. Subjects will be randomized to either SOC alone or SOC plus the application of Miro3D tissue scaffolding.
Standard of Care Treatment or Standard of Care Treatment plus Miro3D Wound MatrixOther
Subjects with complex pressure ulcerations, particularly decubitus or ischial pressure ulcerations (Stage III or greater). These subjects will be randomized to either SOC alone or SOC plus Miro3D tissue scaffolding.
| Study group | Role | What they receive |
|---|---|---|
| Complex soft tissue wound arm | Active comparator | The complex soft tissue wound arm will include consented subjects who have three-dimensional tissue defects, either elevated calf intra-compartmental hypertension treated with fasciotomy or serious infections of the foot or lower extremity that have been controlled with surgical debridement. Subjects will be randomized to either SOC alone or SOC plus Miro3D. Receives: Other: Standard of Care Treatment or Standard of Care Treatment plus Miro3D Wound Matrix |
| Chronic pressure ulceration arm | Active comparator | The chronic pressure ulceration arm will include consented subjects with three-dimensional tissue deficits resulting from Stage III or greater pressure ulcerations, either a decubitus or ischial pressure ulcer that has been present and treated with SOC for at least four (4) weeks. Subjects will be randomized to SOC plus Miro3D or SOC alone. Receives: Other: Standard of Care Treatment or Standard of Care Treatment plus Miro3D Wound Matrix |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of change defined as Percentage Area Reduction or PAR at four weeks after placement or not of the MIRO3D.
Rate of change
Measured: 4 weeks
Secondary outcomes (7)
Assess frequency of MIRO3D applications over a 12-week treatment period
Frequency of MIRO3D applications
Measured: 12 weeks
Assess cost of care, including operating room time and time to hospital discharge for acute wounds
Cost of care (dollars as units of cost)
Measured: 12 weeks
Assess NPWT use
Frequency of NPWT use
Measured: 12 weeks
Assess cellular findings from tissue sampling
Prescence of bacteria or fungus, blood vessels and new healing cells on pathology
Measured: 12 weeks
Assess antibiotic use
Frequency of antibiotic use
Measured: 12 weeks
Assess pain
Subject-reported pain scores using Likert Scale, 0=No Pain - 10=Worst Possible Pain
Measured: 12 weeks
Assess subject-reported ability to move to self-care
Patients will report if they are able to change their dressing on their own without anyone's assistance versus others having to assist (including if home health was able to be stopped) and when this occurred in their treatment course.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2026
- Study start11 Nov 2025
- Primary completionDec 2027 (estimated)
- Study completionJul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for WoundStudies of the same condition, open and under way.
- More trials run by Washington University School of MedicineThe sponsor's other registered studies.
- 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
- Subjects will be randomly assigned to receive one of the 2 study treatments: either standard of care alone or standard of care treatment with Miro 3D. Efficacy will be determined by quantifying wound closure and PAR toward closure. The trial will also examine cost of care, number of serial placements of Miro3D, and time to hospital discharge for acute wounds.
- Masking
- None (open label)
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- John Kirby, MD, Principal investigator, Washington University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07347106
- Sponsor's protocol ID
- 202506105
- Status last verified
- Aug 2026
- First submitted
- 19 Aug 2025
- Last updated
- 25 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Fridman R, Rafat P, Van Gils CC, Horn D, Vayser D, Lambert JC Jr. Treatment of Hard-to-heal Diabetic Foot Ulcers With a Hepatic-derived Wound Matrix. Wounds. 2020 Sep;32(9):244-252. Epub 2020 Jun 21.
PubMed 32813669Doupis J, Veves A. Classification, diagnosis, and treatment of diabetic foot ulcers. Wounds. 2008 May;20(5):117-26.
PubMed 25942412International best practice guidelines: wound management in diabetic foot ulcers. Wounds Int. May 10, 2013. www.woundsinternational.com/resources/details/best-practice-guidelines-wound-management-diabetic-foot-ulcers
Singh N, Armstrong DG, Lipsky BA. Preventing foot ulcers in patients with diabetes. JAMA. 2005 Jan 12;293(2):217-28. doi: 10.1001/jama.293.2.217.
PubMed 15644549NCD Risk Factor Collaboration (NCD-RisC). Worldwide trends in diabetes since 1980: a pooled analysis of 751 population-based studies with 4.4 million participants. Lancet. 2016 Apr 9;387(10027):1513-1530. doi: 10.1016/S0140-6736(16)00618-8. Epub 2016 Apr 6.
PubMed 27061677Cao X, Lin X, Li N, Zhao X, Zhou M, Zhao Y. Animal tissue-derived biomaterials for promoting wound healing. Mater Horiz. 2023 Aug 29;10(9):3237-3256. doi: 10.1039/d3mh00411b.
PubMed 37278612Chaudhari AA, Vig K, Baganizi DR, Sahu R, Dixit S, Dennis V, Singh SR, Pillai SR. Future Prospects for Scaffolding Methods and Biomaterials in Skin Tissue Engineering: A Review. Int J Mol Sci. 2016 Nov 25;17(12):1974. doi: 10.3390/ijms17121974.
PubMed 27898014Sharma S, Rai VK, Narang RK, Markandeywar TS. Collagen-based formulations for wound healing: A literature review. Life Sci. 2022 Feb 1;290:120096. doi: 10.1016/j.lfs.2021.120096. Epub 2021 Oct 26.
PubMed 34715138Ansari T, Southgate A, Obiri-Yeboa I, Jones LG, Greco K, Olayanju A, Mbundi L, Somasundaram M, Davidson B, Sibbons PD. Development and Characterization of a Porcine Liver Scaffold. Stem Cells Dev. 2020 Mar 1;29(5):314-326. doi: 10.1089/scd.2019.0069. Epub 2020 Feb 11.
PubMed 31854227Bertsch C, Marechal H, Gribova V, Levy B, Debry C, Lavalle P, Fath L. Biomimetic Bilayered Scaffolds for Tissue Engineering: From Current Design Strategies to Medical Applications. Adv Healthc Mater. 2023 Jul;12(17):e2203115. doi: 10.1002/adhm.202203115. Epub 2023 Mar 8.
PubMed 36807830
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Randomized Controlled Trial of Miro3D Wound Matrix With Standard of Care Versus Standard of Care Alone in Treating Acute Soft Tissue Wounds and Chronic Pressure Ulcerations
- ClinicalTrials.gov ID
- NCT07347106
- Acronym / sponsor ID
- 202506105
- Conditions
- Wound
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Study start
- 11 Nov 2025 (actual)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Jul 2028 (estimated)
- First posted
- 16 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this research study is to evaluate the outcomes for patients managed with standard of care (SOC) wound treatments and those managed with standard of care treatment and tissue scaffolds, specifically Miro 3D. Tissue scaffolds like Miro 3D are 3-dimentional frameworks for collagen protein that provide structure and protection to help wounds heal.
Detailed description
Acellular tissue scaffolds, such as Miro3D, were developed to aid in the management of complex tissue defect wounds and ulcerations by providing a structural matrix that supports cellular infiltration and tissue regeneration. However, high-quality prospective data remain limited, particularly regarding soft tissue deficits and pressure ulcerations. This prospective RCT is designed to evaluate the efficacy and outcomes of subjects randomized to receive either SOC alone or SOC with the addition of tissue scaffolding techniques (Miro3D) over a twelve (12)-week timeframe.
The trial will investigate two categories of complex wounds: soft tissue wounds, including post-fasciotomy wounds and wounds resulting from necrotizing skin and soft tissue infection (NSSTI), and chronic pressure ulcerations, with a focus on decubitus and ischial pressure ulcers. The trial aims to generate real-world data, including cost-effectiveness parameters, and features a crossover arm to evaluate the impact of delayed wound bed preparation and the application of tissue scaffolds.
Additionally, the trial will evaluate healing quality using digital wound photography and mathematical analysis of wound redness as a surrogate marker for granulation tissue formation. Time to hospital discharge will also be tracked for acute wounds to assess cost and resource utilization. By analyzing the effectiveness of Miro3D in combination with SOC, this trial seeks to provide meaningful insights into optimizing wound management strategies.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Subjects will be randomly assigned to receive one of the 2 study treatments: either standard of care alone or standard of care treatment with Miro 3D. Efficacy will be determined by quantifying wound closure and PAR toward closure. The trial will also examine cost of care, number of serial placements of Miro3D, and time to hospital discharge for acute wounds.
| Arm | Type | Receives |
|---|---|---|
| Complex soft tissue wound arm | Active comparator | Other: Standard of Care Treatment or Standard of Care Treatment plus Miro3D Wound MatrixThe complex soft tissue wound arm will include consented subjects who have three-dimensional tissue defects, either elevated calf intra-compartmental hypertension treated with fasciotomy or serious infections of the foot or lower extremity that have been controlled with surgical debridement. Subjects will be randomized to either SOC alone or SOC plus Miro3D. |
| Chronic pressure ulceration arm | Active comparator | Other: Standard of Care Treatment or Standard of Care Treatment plus Miro3D Wound MatrixThe chronic pressure ulceration arm will include consented subjects with three-dimensional tissue deficits resulting from Stage III or greater pressure ulcerations, either a decubitus or ischial pressure ulcer that has been present and treated with SOC for at least four (4) weeks. Subjects will be randomized to SOC plus Miro3D or SOC alone. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Subjects must fulfill all the following inclusion criteria to qualify for enrollment:
Key exclusion criteria (13 listed)
- Subjects who meet any of the following criteria will be excluded from trial participation:
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 Care Treatment or Standard of Care Treatment plus Miro3D Wound MatrixSubjects with lower extremity three-dimensional tissue defects, including those resulting from elevated calf intra-compartmental hypertension treated with decompressive fasciotomies or serious NSSTIs of the foot or lower extremities (including the pelvis as part of the lower extremity). These defects must have been controlled with surgical debridement. Subjects will be randomized to either SOC alone or SOC plus the application of Miro3D tissue scaffolding. | Other | Complex soft tissue wound arm |
| Standard of Care Treatment or Standard of Care Treatment plus Miro3D Wound MatrixSubjects with complex pressure ulcerations, particularly decubitus or ischial pressure ulcerations (Stage III or greater). These subjects will be randomized to either SOC alone or SOC plus Miro3D tissue scaffolding. | Other | Chronic pressure ulceration arm |
Primary outcome
Rate of change defined as Percentage Area Reduction or PAR at four weeks after placement or not of the MIRO3D.
Time frame: 4 weeks
Rate of change
7 secondary outcomes
Assess frequency of MIRO3D applications over a 12-week treatment period
Time frame: 12 weeks
Assess cost of care, including operating room time and time to hospital discharge for acute wounds
Time frame: 12 weeks
Assess NPWT use
Time frame: 12 weeks
Assess cellular findings from tissue sampling
Time frame: 12 weeks
Assess antibiotic use
Time frame: 12 weeks
Assess pain
Time frame: 12 weeks
Assess subject-reported ability to move to self-care
Time frame: 12 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Aug 2026.
- Background: PubMed 32813669Fridman R, Rafat P, Van Gils CC, Horn D, Vayser D, Lambert JC Jr. Treatment of Hard-to-heal Diabetic Foot Ulcers With a Hepatic-derived Wound Matrix. Wounds. 2020 Sep;32(9):244-252. Epub 2020 Jun 21.
- Background: PubMed 25942412Doupis J, Veves A. Classification, diagnosis, and treatment of diabetic foot ulcers. Wounds. 2008 May;20(5):117-26.
- BackgroundInternational best practice guidelines: wound management in diabetic foot ulcers. Wounds Int. May 10, 2013. www.woundsinternational.com/resources/details/best-practice-guidelines-wound-management-diabetic-foot-ulcers
- Background: PubMed 15644549Singh N, Armstrong DG, Lipsky BA. Preventing foot ulcers in patients with diabetes. JAMA. 2005 Jan 12;293(2):217-28. doi: 10.1001/jama.293.2.217.
- Background: PubMed 27061677NCD Risk Factor Collaboration (NCD-RisC). Worldwide trends in diabetes since 1980: a pooled analysis of 751 population-based studies with 4.4 million participants. Lancet. 2016 Apr 9;387(10027):1513-1530. doi: 10.1016/S0140-6736(16)00618-8. Epub 2016 Apr 6.
- Background: PubMed 37278612Cao X, Lin X, Li N, Zhao X, Zhou M, Zhao Y. Animal tissue-derived biomaterials for promoting wound healing. Mater Horiz. 2023 Aug 29;10(9):3237-3256. doi: 10.1039/d3mh00411b.
- Background: PubMed 27898014Chaudhari AA, Vig K, Baganizi DR, Sahu R, Dixit S, Dennis V, Singh SR, Pillai SR. Future Prospects for Scaffolding Methods and Biomaterials in Skin Tissue Engineering: A Review. Int J Mol Sci. 2016 Nov 25;17(12):1974. doi: 10.3390/ijms17121974.
- Background: PubMed 34715138Sharma S, Rai VK, Narang RK, Markandeywar TS. Collagen-based formulations for wound healing: A literature review. Life Sci. 2022 Feb 1;290:120096. doi: 10.1016/j.lfs.2021.120096. Epub 2021 Oct 26.
- Background: PubMed 31854227Ansari T, Southgate A, Obiri-Yeboa I, Jones LG, Greco K, Olayanju A, Mbundi L, Somasundaram M, Davidson B, Sibbons PD. Development and Characterization of a Porcine Liver Scaffold. Stem Cells Dev. 2020 Mar 1;29(5):314-326. doi: 10.1089/scd.2019.0069. Epub 2020 Feb 11.
- Background: PubMed 36807830Bertsch C, Marechal H, Gribova V, Levy B, Debry C, Lavalle P, Fath L. Biomimetic Bilayered Scaffolds for Tissue Engineering: From Current Design Strategies to Medical Applications. Adv Healthc Mater. 2023 Jul;12(17):e2203115. doi: 10.1002/adhm.202203115. Epub 2023 Mar 8.
- 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.
John Kirby, MD principal investigator
Washington University School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study of Wound, run by Washington University School of Medicine 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 13 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 25 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 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.
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 Aaron Day, RN ((314) 747-4129, aaronday@wustl.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of change defined as Percentage Area Reduction or PAR at four weeks after placement or not of the MIRO3D. (time frame: 4 weeks). 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 NCT07347106, which also lists 10 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 25 Aug 2026.