Miro3D Randomized Controlled Trial (RCT)

NCT07347106 | Recruiting

• 1 other identifier: 202506105
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief 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. Tissue scaffolds like Miro 3D are 3-dimentional frameworks for collagen protein that provide structure and protection to help wounds heal.

Conditions

Wound

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• Assess frequency of MIRO3D applications over a 12-week treatment period

  12 weeks

• Assess cost of care, including operating room time and time to hospital discharge for acute wounds

  12 weeks

• Assess NPWT use

  12 weeks

• Assess cellular findings from tissue sampling

  12 weeks

• Assess antibiotic use

  12 weeks

Study Arms (2)

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.

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.

Other: Standard of Care Treatment or Standard of Care Treatment plus Miro3D Wound Matrix

Interventions

Standard of Care Treatment or Standard of Care Treatment plus Miro3D Wound Matrix OTHER

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.

Complex soft tissue wound arm

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Washington University School of Medicine: lead

Study Sites (1)

Washington University School of Medicine

St Louis, Missouri, 63110, United States

RECRUITING

Related Publications (10)

• 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.

  PMID: 32813669 BACKGROUND

• Doupis J, Veves A. Classification, diagnosis, and treatment of diabetic foot ulcers. Wounds. 2008 May;20(5):117-26.

  PMID: 25942412 BACKGROUND

• 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

  BACKGROUND

• 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.

  PMID: 15644549 BACKGROUND

• 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.

  PMID: 27061677 BACKGROUND

• 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.

  PMID: 37278612 BACKGROUND

• 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.

  PMID: 27898014 BACKGROUND

• 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.

  PMID: 34715138 BACKGROUND

• 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.

  PMID: 31854227 BACKGROUND

• 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.

  PMID: 36807830 BACKGROUND

MeSH Terms

Conditions

Wounds and Injuries

Study Officials

• John Kirby, MD

  Washington University School of Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Aaron Day, RN

CONTACT

(314) 747-4129; aaronday@wustl.edu

Stacey Reese, RN, BSN

CONTACT

(443) 865-3970; staceyreese@wustl.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: August 19, 2025
• First Posted: January 16, 2026
• Study Start: January 1, 2026
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): July 1, 2028
• Last Updated: January 20, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)