Miro3D Wound Matrix for Treatment of Diabetic Foot Ulcers

Conditions

• Chronic Wounds
• Diabetic Foot
• Diabetic Foot Ulcers (DFUs)

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Miro3D Wound Matrix — DEVICE
  Miro3D Wound Matrix is a sterile, acellular, three-dimensional scaffold derived from porcine liver tissue and applied topically to the wound following appropriate wound bed preparation to support tissue regeneration and healing.
• Standard of Care — OTHER
  Standard of care includes sharp debridement, offloading using a protocol-defined device, and appropriate moisture-retentive dressings.

Study Details

This study is designed to evaluate whether the Miro3D Wound Matrix, when used in addition to standard of care, improves healing outcomes in patients with chronic diabetic foot ulcers. Diabetic foot ulcers are a common and serious complication of diabetes and may be difficult to heal despite appropriate treatment. Standard of care typically includes regular wound cleaning, debridement (removal of dead tissue), offloading (reducing pressure on the wound), and moisture-balancing dressings. However, some wounds fail to heal with standard treatment alone. Miro3D Wound Matrix is a three-dimensional, acellular scaffold derived from porcine tissue that is intended to support wound healing. This study will compare outcomes in patients treated with Miro3D plus standard of care versus standard of care alone. Approximately 180 adult subjects with non-healing diabetic foot ulcers will be enrolled at multiple clinical sites in the United States. After a two-week screening period, eligible participants will be randomly assigned to receive either Miro3D in addition to standard of care or standard of care alone. Subjects will be followed for up to 12 weeks with weekly clinic visits. The primary objective of the study is to determine whether treatment with Miro3D increases the rate of complete wound closure and improves reduction in wound size compared to standard of care alone. Safety will also be evaluated by monitoring adverse events throughout the study.

Key Dates

Start date

Jun 30, 2026

Status verified

Jun 2026

Primary completion

Mar 31, 2027

Completion

May 31, 2027

Study Design

Enrollment

180 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Miro3D Wound Matrix Plus Standard of Care
  Participants will receive Miro3D Wound Matrix in addition to standard of care, including sharp debridement, offloading using a protocol-defined device, and appropriate moisture-retentive dressings.
• Active Comparator: Standard of Care Alone
  Participants will receive standard of care alone, including sharp debridement, offloading using a protocol-defined device, and appropriate moisture-retentive dressings.

Primary Outcome Measure

Proportion of Participants Achieving Complete Wound Closure of the Target Diabetic Foot Ulcer at 12 Weeks [ Time Frame: Up to 12 weeks ]

Central Contacts

• Erin Badali
  763-284-6785
  [email protected]
• Greg Smock
  763-284-6780
  [email protected]

Locations (14)

Find similar trials in Phoenix, AZ

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