Miro3D Randomized Controlled Trial (RCT)

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.

Study Overview

• Status: Recruiting
• Conditions: Wound
• Intervention / Treatment: Other: Standard of Care Treatment or Standard of Care Treatment plus Miro3D Wound Matrix; Other: Standard of Care Treatment or Standard of Care Treatment plus Miro3D Wound Matrix

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 Type: Interventional
• Enrollment (Estimated): 70
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Aaron Day, RN; Phone Number: (314) 747-4129; Email: aaronday@wustl.edu
• Study Contact Backup: Name: Stacey Reese, RN, BSN; Phone Number: (443) 865-3970; Email: staceyreese@wustl.edu

Study Locations

• United States
  • Missouri
    • St Louis, Missouri, United States, 63110
      • Recruiting
      • Washington University School of Medicine
      • Contact: John Kirby, M.D.; Phone Number: 314-747-0556; Email: kirbyj@wustl.edu
      • Contact: Aaron Day, RN, BSN; Phone Number: 3143628041; Email: aaronday@wustl.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Subjects must fulfill all the following inclusion criteria to qualify for enrollment:

  1. Men or women 18-90 years of age at enrollment.
  2. Ability to sign consent by subject or LAR.

  3. 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.
  4. Subjects must agree to proper offloading and/or compression of the wound or ulcer throughout the trial.
  5. Written informed consent is required for digital photo imaging.
  6. 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.
  7. 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.

Exclusion Criteria:

• Subjects who meet any of the following criteria will be excluded from trial participation:

  1. The PAR of the pressure ulcer arm has reduced by 50% or more after four (4) weeks of SOC.
  2. Wounds with active invasive infection not yet controlled in the opinion of a trial investigator.
  3. Wounds with vascular insufficiencies requiring revascularization.
  4. 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.
  5. Undergoing chemotherapy.
  6. History of radiation to the area of the index wound or ulcer, regardless of time since last radiation treatment.
  7. Use of investigational drugs or therapies within thirty (30) days before screening.
  8. On dialysis.
  9. Sensitivity, allergy, or contraindication to Miro3D and/or NPWT or its components.
  10. Presence of third-degree burns.
  11. Index wound or ulcer exhibiting worsening ischemia or gangrene at screening.
  12. Subjects moving toward palliative or comfort care.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Complex soft tissue wound arm; 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.	Other: Standard of Care Treatment or Standard of Care Treatment plus Miro3D Wound Matrix; 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.; Other: Standard of Care Treatment or Standard of Care Treatment plus Miro3D Wound Matrix; 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.
Active Comparator: Chronic pressure ulceration arm; 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.	Other: Standard of Care Treatment or Standard of Care Treatment plus Miro3D Wound Matrix; 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.; Other: Standard of Care Treatment or Standard of Care Treatment plus Miro3D Wound Matrix; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of change defined as Percentage Area Reduction or PAR at four weeks after placement or not of the MIRO3D.	Rate of change	4 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Assess frequency of MIRO3D applications over a 12-week treatment period	Frequency of MIRO3D applications	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)	12 weeks
Assess NPWT use	Frequency of NPWT use	12 weeks
Assess cellular findings from tissue sampling	Prescence of bacteria or fungus, blood vessels and new healing cells on pathology	12 weeks
Assess antibiotic use	Frequency of antibiotic use	12 weeks
Assess pain	Subject-reported pain scores using Likert Scale, 0=No Pain - 10=Worst Possible Pain	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.	12 weeks

Collaborators and Investigators

• Sponsor: Washington University School of Medicine
• Investigators: Principal Investigator: John Kirby, MD, Washington University School of Medicine

Publications and helpful links

General Publications

• 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.
• NCD 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.
• 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.
• Doupis J, Veves A. Classification, diagnosis, and treatment of diabetic foot ulcers. Wounds. 2008 May;20(5):117-26.
• International 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
• Cao 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.
• Chaudhari 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.
• Sharma 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.
• Ansari 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.
• Bertsch 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.

Study record dates

Study Major Dates

• Study Start (Estimated): January 1, 2026
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): July 1, 2028

Study Registration Dates

• First Submitted: August 19, 2025
• First Submitted That Met QC Criteria: January 7, 2026
• First Posted (Estimated): January 16, 2026

Study Record Updates

• Last Update Posted (Actual): January 20, 2026
• Last Update Submitted That Met QC Criteria: January 15, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries
• Other Study ID Numbers: 202506105

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No