A Randomized Controlled Trial Evaluating Reprise Biomedical's Miro3D Wound Matrix and Standard of Care Versus Standard of Care Alone in Treating Wagner Grade 1 Diabetic Foot Ulcers and Dehiscence
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 30
- 试验地点
- 4
- 主要终点
- Percent Area Reduction (PAR) and Granulation Tissue Formation at 4 Weeks
研究概览
简要总结
This study is a prospective, randomized controlled trial designed to evaluate the effectiveness of Miro3D Wound Matrix plus Standard of Care (SOC) compared to SOC alone in treating Wagner Grade 1 diabetic foot ulcers (DFUs) and wound dehiscence in an outpatient setting. The trial is sponsored by Reprise Biomedical, Inc. and aims to explore whether the addition of Miro3D-a three-dimensional, acellular porcine-derived wound matrix-enhances wound healing outcomes compared to SOC alone.
Purpose of the Study: The primary purpose of the study is to determine whether applying Miro3D in combination with SOC leads to improved healing of diabetic foot ulcers compared to SOC alone. Specifically, the study seeks to assess early wound healing progress at four weeks (as measured by percent area reduction and granulation tissue formation) as a predictor of complete healing by twelve weeks.
Key Question the Study Seeks to Answer: Does the addition of Miro3D to standard wound care improve the healing rate and overall wound outcomes for patients with Wagner Grade 1 diabetic foot ulcers or dehisced wounds compared to standard care alone?
Study Design Overview: Subjects who meet inclusion/exclusion criteria will be randomized into one of two groups:
- Miro3D + SOC arm - receiving Miro3D weekly for 4 weeks, then biweekly if needed, for up to 12 weeks.
- SOC alone (control) arm - receiving SOC without Miro3D. If the wound remains unhealed at 12 weeks in the SOC alone arm, participants may "crossover" to receive Miro3D treatment under the same schedule for an additional 12 weeks.
Primary Endpoint:
1. Percent Area Reduction (PAR) and granulation tissue formation at 4 weeks, serving as predictors for wound healing at 12 weeks.
Secondary Endpoints:
- Quality of Life (QOL) improvements, including pain, mobility, and emotional well-being, assessed using a validated Wound/Ulcer-QOL tool.
- Pain levels using a Visual Analog Scale (VAS) at each visit.
Population: Approximately 30 adult subjects (15 per arm) with Wagner Grade 1 diabetic foot ulcers or dehisced wounds will be enrolled. Subjects must have adequate blood flow, demonstrate wound size criteria, and commit to offloading and follow-up care.
Follow-Up: Subjects will be followed weekly through the 12-week study period. Healed subjects will undergo confirmation visits at 2 and 4 weeks post-closure. Subjects in the crossover arm will be followed for an additional 12 weeks if their wound was unhealed at the primary endpoint.
Statistical Considerations: Data will be summarized using descriptive statistics, including wound measurements, infection status, and healing rates. Comparative analysis will be conducted between treatment groups and schedules (weekly vs. biweekly Miro3D application). Adverse events (AEs), serious adverse events (SAEs), and device-related events will also be documented.
This study aims to generate clinical evidence supporting the use of Miro3D as a beneficial adjunct to standard wound care in promoting early and complete healing of diabetic foot ulcers.
详细描述
This prospective, randomized controlled trial evaluates the clinical effectiveness of Reprise Biomedical's Miro3D Wound Matrix in conjunction with standard of care (SOC) compared to SOC alone in treating Wagner Grade 1 diabetic foot ulcers (DFUs) in an outpatient setting. The investigational product, Miro3D, is a porcine liver-derived, acellular, three-dimensional extracellular matrix designed to support healing in complex wound environments by providing a biologically active scaffold that facilitates cell infiltration and tissue remodeling. This study aims to generate robust clinical evidence supporting Miro3D's role as an advanced biologic dressing for early and sustained wound healing in diabetic patients.
Background and Rationale: Diabetic foot ulcers are a common and serious complication of diabetes mellitus, affecting approximately 15-25% of individuals with diabetes over their lifetime. These ulcers are associated with high morbidity, increased healthcare utilization, and significant risk of lower extremity amputation. Despite established guidelines, many DFUs fail to heal adequately with standard of care alone, especially when early progress is not observed. According to consensus recommendations, wounds that do not demonstrate at least a 50% reduction in area within the first four weeks of SOC are unlikely to achieve closure by 12 weeks and are considered candidates for advanced wound therapies.
Advanced biologic matrices aim to address the limitations of SOC by enhancing the local wound environment. Miro3D is a perfusion-decellularized extracellular matrix derived from porcine liver, preserving native microvascular architecture and providing a highly porous scaffold for cellular infiltration. Unlike many sheet-based dermal matrices, Miro3D possesses significant three-dimensional structure and volume, making it suitable for filling shallow to moderately deep wound beds. The device is supplied sterile and dry, rehydrated at the point of care, trimmed to fit, and applied directly to the wound bed.
This study is designed to evaluate whether the addition of Miro3D to SOC accelerates healing and improves outcomes in Wagner Grade 1 DFUs, a common clinical presentation that often remains refractory to SOC alone. The trial also includes a crossover design for non-responders in the SOC arm, enhancing ethical treatment access while generating additional observational data.
Device Description and Mechanism of Action: Miro3D Wound Matrix is a sterile, acellular scaffold composed of porcine-derived extracellular matrix processed via perfusion decellularization to retain native liver architecture. The matrix is characterized by high porosity, preserved vascular pathways, and structural integrity, supporting rapid integration into the wound bed. Once rehydrated, Miro3D becomes pliable and conformable, suitable for application to irregular wound geometries.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Must be at least 18 years of age and capable of providing informed consent.
- •Must have a full- or partial-thickness Wagner Grade 1 ulcer or wound on the foot; if involving the malleolus, no more than 50% of the wound may be above the midpoint of the medial malleolus.
- •Index wound/ulcer must be between 1 cm² and 20 cm² post-debridement.
- •Wound/ulcer must have been present for at least 4 weeks prior to screening.
- •Adequate circulation must be documented by one of the following: ABI between 0.7-1.2, TBI ≥ 0.7, TCPO2 ≥ 40 mmHg, or triphasic/biphasic Doppler waveforms.
- •Other wounds, if present, must be at least 2 cm from the index wound/ulcer.
- •Any previous infections must have been adequately treated per IDSA guidelines.
- •Subjects must agree to proper offloading and/or compression, have a stable living environment, and be able to attend follow-up visits.
- •Must provide written consent for digital imaging.
- •For Miro3D arm: Index wound/ulcer must have a clean base free of devitalized tissue or debris at the time of product placement.
排除标准
- •Index wound/ulcer has reduced ≥30% after two weeks of SOC from screening to baseline.
- •Poorly controlled diabetes (HbA1c ≥ 12%).
- •Active, untreated or uncontrolled osteomyelitis.
- •Malignancy or vasculitis at the wound site.
- •Undergoing chemotherapy.
- •On dialysis.
- •Use of investigational drugs or therapies within 30 days prior to screening.
- •Conditions that would compromise study participation or adherence.
- •Known sensitivity to porcine materials.
- •Third-degree burns.
- •Worsening ischemia or gangrene at screening.
- •History of radiation to the wound site.
- •Exposed internal fixation, implants, or hardware in the wound.
- •Patient is transitioning to palliative or comfort care.
研究组 & 干预措施
Miro3D Wound Matrix plus Standard of Care (SOC)
Subjects randomized to this arm receive Miro3D Wound Matrix in combination with standard of care wound treatment.
- Miro3D is applied once every 7 days for the first 4 weeks.
- If the wound is not healed after 4 weeks, Miro3D is applied biweekly (every 14 days) through week 12 or until healing.
- All subjects in this arm are assessed weekly for healing progress, wound measurements, granulation, pain (VAS), and QOL.
干预措施: Miro3D Wound Matrix (Device)
Miro3D Wound Matrix plus Standard of Care (SOC)
Subjects randomized to this arm receive Miro3D Wound Matrix in combination with standard of care wound treatment.
- Miro3D is applied once every 7 days for the first 4 weeks.
- If the wound is not healed after 4 weeks, Miro3D is applied biweekly (every 14 days) through week 12 or until healing.
- All subjects in this arm are assessed weekly for healing progress, wound measurements, granulation, pain (VAS), and QOL.
干预措施: Standard of Care (SOC) (Other)
Standard of Care (SOC) Alone
Subjects in this arm receive standard wound care without Miro3D, including wound cleaning, debridement, offloading, and appropriate dressings.
- Healing progress is evaluated weekly over the 12-week treatment period.
- Subjects whose wounds remain unhealed at week 12 may elect to crossover to Miro3D treatment, following the same protocol used in Arm 1.
干预措施: Standard of Care (SOC) (Other)
结局指标
主要结局
Percent Area Reduction (PAR) and Granulation Tissue Formation at 4 Weeks
时间窗: 4 weeks post-randomization
The primary endpoint is the percent area reduction (PAR) and granulation tissue formation of the index wound or ulcer measured at 4 weeks. This serves as a predictor of complete healing by week 12. Wound size is measured manually using a ruler, and depth is assessed with a probe. Granulation is visually assessed by trained clinicians.
次要结局
- Complete Wound or Ulcer Healing by Week 12(Up to 12 weeks post-randomization)
- Quality of Life (QOL) Assessment Using Wound-QOL Instrument(Baseline, Week 4, Week 8, and Week 12 or at early termination)
- Pain Score Assessment Using Visual Analog Scale (VAS)(Collected at every study visit (weekly through week 12))