Miro3D Wound Matrix for Treatment of Diabetic Foot Ulcers (FOCUS 3D)
A Randomized Controlled Multicenter Trial, Examining the Effect of Miro3D Wound Matrix on the Rate of Complete Wound Closure of Chronic Diabetic Foot Ulcers
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.
연구 개요
상태
상태
정황
정황
개입 / 치료
개입 / 치료
상세 설명
This is a prospective, multicenter, open-label, randomized controlled trial designed to evaluate the safety and effectiveness of the Miro3D Wound Matrix in the treatment of chronic, non-healing diabetic foot ulcers (DFUs).
Diabetic foot ulcers represent a significant clinical and economic burden and are associated with increased risk of infection, hospitalization, and amputation. Despite adherence to standard of care (SOC), including offloading, debridement, infection control, and moisture management, a substantial proportion of DFUs fail to achieve complete healing. This study aims to assess whether adjunctive treatment with Miro3D Wound Matrix can improve healing outcomes compared to SOC alone.
Miro3D Wound Matrix is a sterile, acellular, three-dimensional scaffold derived from porcine liver tissue. The matrix is designed to provide a structural environment that supports tissue regeneration and wound healing. The product is applied topically to the wound following appropriate wound bed preparation.
Approximately 180 adult subjects with Wagner Grade 1 or 2 diabetic foot ulcers will be enrolled across up to 20 clinical sites in the United States. Subjects must have ulcers present for at least 4 weeks but less than 12 months and must demonstrate less than 25% reduction in wound area during a two-week screening period under standard of care.
Following screening, eligible subjects will be randomized in a 1:1 ratio to one of two treatment arms: treatment with Miro3D Wound Matrix in addition to standard of care, or standard of care alone.
Standard of care will include sharp debridement, offloading using a protocol-defined device, and appropriate moisture-retentive dressings.
Subjects will be evaluated at weekly intervals for up to 12 weeks. At each visit, assessments will include wound measurement, photographic documentation, infection status, pain assessment using the Numeric Pain Rating Scale (NPRS), and monitoring of adverse events. At select sites, additional exploratory imaging assessments may be performed, including near-infrared tissue oxygenation and fluorescence imaging.
The primary endpoints of the study are complete wound closure at 12 weeks, defined as full re-epithelialization without drainage or need for dressing, with closure confirmed at a single healing confirmation visit conducted two weeks after complete closure is initially documented, and percentage area reduction of the target ulcer over the study period. Secondary endpoints include change in pain associated with the ulcer and the incidence and frequency of adverse events. Exploratory endpoints will assess spatial and temporal changes in tissue oxygenation and fluorescence imaging characteristics at technology-enabled sites.
The study will use a Bayesian adaptive statistical framework, incorporating prior information and observed data to estimate treatment effects. Interim analyses may be conducted to evaluate efficacy, safety, and sample size assumptions.
This study is intended to generate clinical evidence supporting the use of Miro3D Wound Matrix as an adjunctive therapy for improving healing outcomes in patients with chronic diabetic foot ulcers.
연구 유형
연구 유형
등록 (추정된)
등록
단계
단계
- 해당 없음
연락처 및 위치
연구 연락처
연구 연락처
- 이름: Erin Badali
- 전화번호: 763-284-6785
- 이메일: ebadali@reprisebio.com
연구 연락처 백업
- 이름: Greg Smock
- 전화번호: 763-284-6780
- 이메일: gsmock@reprisebio.com
연구 장소
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Arizona
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Phoenix, Arizona, 미국, 85032
- 모병
- Advanced Foot Care
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수석 연구원:
- Jaminelli Banks
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연락하다:
- Krishna S Penumarthi
- 전화번호: 857-891-3039
- 이메일: krishnap@advancedfootcareusa.com
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Florida
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Coconut Creek, Florida, 미국, 33073
- 아직 모집하지 않음
- West Boca Center for Wound Healing
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연락하다:
- Eric Lullove
- 전화번호: 561-989-9780
- 이메일: drlullove@drlullove.com
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수석 연구원:
- Eric Lullove
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Coral Gables, Florida, 미국, 33134
- 모병
- Solutions Medical Research
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연락하다:
- Leandro Pena
- 전화번호: 305-425-1238
- 이메일: sitedirector@solutionsmedicalresearch.com
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수석 연구원:
- Francisco J Oliva
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Miami, Florida, 미국, 33156
- 아직 모집하지 않음
- Doctors Research Network
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연락하다:
- Maria Surprenant
- 전화번호: 305-665-3017
- 이메일: msurprenant@drnmiami.com
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수석 연구원:
- Maria Surprenant
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Tamarac, Florida, 미국, 33321
- 모병
- Barry University
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연락하다:
- Maria Swartz
- 전화번호: 954-721-4806
- 이메일: mswartz@barry.edu
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수석 연구원:
- Cherison Cuffy
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Massachusetts
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Hyde Park, Massachusetts, 미국, 02136
- 아직 모집하지 않음
- Clinical Trials of New England
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연락하다:
- Kenny Carberry
- 전화번호: 617-827-1803
- 이메일: kcarberry@clinicaltrialsne.com
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수석 연구원:
- Michael Lowney
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Missouri
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St Louis, Missouri, 미국, 63128
- 아직 모집하지 않음
- Mercy Hyperbaric and Wound Care
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연락하다:
- Preeti Srivastava
- 전화번호: 314-251-7712
- 이메일: preeti.srivastava@mercy.net
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수석 연구원:
- Amy Couch
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St Louis, Missouri, 미국, 63128
- 아직 모집하지 않음
- St. Louis Foot & Ankle
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연락하다:
- Bonnie Weiss
- 전화번호: 314-596-9670
- 이메일: blsweiss.practicemanager@gmail.com
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수석 연구원:
- Raymond Abdo
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St Louis, Missouri, 미국, 63136
- 아직 모집하지 않음
- Christian Hospital Wound Center
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연락하다:
- Christine Kuehnel
- 전화번호: 314-362-5298
- 이메일: ckuehnel@wustl.edu
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수석 연구원:
- Bradley Freeman
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New York
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New York, New York, 미국, 10029
- 아직 모집하지 않음
- Icahn School of Medicine at Mount Sinai
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수석 연구원:
- John Lantis
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연락하다:
- Garismar Ramirez
- 전화번호: 212-523-6905
- 이메일: Garismar.Ramirez@mountsinai.org
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Ohio
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Columbus, Ohio, 미국, 43213
- 모병
- ABC Podiatry
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수석 연구원:
- Richard Schilling
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연락하다:
- Lyndsie Walker
- 전화번호: 614-755-2290
- 이메일: lwalker@abcpodiatry.com
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Oklahoma
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Oklahoma City, Oklahoma, 미국, 73159
- 아직 모집하지 않음
- Dynamic Wound Care
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연락하다:
- Jerry Bellamy
- 전화번호: 713-517-5176
- 이메일: jerry.bellamy@haloclinicalresearch.com
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수석 연구원:
- Alex Cralley
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Texas
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Houston, Texas, 미국, 77035
- 모병
- Caring Foot and Ankle Specialists
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연락하다:
- Jerry Bellamy
- 전화번호: 713-517-5176
- 이메일: jerry.bellamy@haloclinicalresearch.com
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수석 연구원:
- Gian Steinhauser
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Humble, Texas, 미국, 77338
- 모병
- Vital Heart and Vein
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연락하다:
- Jerry Bellamy
- 전화번호: 713-517-5176
- 이메일: jerry.bellamy@haloclinicalresearch.com
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수석 연구원:
- Kent Jarvis
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참여기준
자격 기준
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
설명
Inclusion Criteria
- Subjects 18 years of age or older.
- Subject history of Type I or Type II Diabetes Mellitus requiring treatment with oral medications and/or insulin replacement therapy.
- A diabetic foot ulcer present for greater than 4 weeks (documented in the medical record) but less than 12 months duration if being treated with active SOC.
- Objectively, less than 25% wound area reduction in the two-week screening period prior to randomization.
- Study ulcer is a minimum of 1.0cm2 and a maximum of 25 cm2 post-debridement at first treatment visit.
- Index ulcer and/or index ulcer limb may have had prior infection, but infection(s) must be adequately treated and controlled as defined by IDSA Guidelines Grade level 1.
- The subject is able and willing to follow the protocol requirements.
Subject has signed informed consent.
Subjects with the following ulcer:
A. Presence of a diabetic foot ulcer Wagner 1 or 2 grade at the first screening visit on any aspect of the foot, provided 50% of the wound sits below the level of the malleolus. This includes DFUs as a result of open amputation sites and surgical wound dehiscence as long as all other criteria are met. [NOTE: If two or more DFUs are present with the same grade, the index ulcer is the largest ulcer and the only one evaluated in the study. Index ulcer must be more than 2 cm distant apart.]
- Adequate circulation to the affected foot as demonstrated by a dorsum transcutaneous oxygen measurement (TCOM) or a skin perfusion pressure (SPP) measurement of ≥ 30 mmHg; Toe pressures >50mmHg; an ABI between 0.7 and ≤ 1.3, or TBI of >0.6 within 3 months of the first Screening Visit.
- Negative pregnancy test for females of childbearing potential (e.g., not post- menopausal for at least one year or surgically sterile). Females of childbearing potential must be willing to use acceptable methods of contraception (birth control pills, barriers, or abstinence) starting at Screening and continuing through the duration of their study participation.
- The index ulcer has been offloaded with protocol defined offloading device throughout the study run-in period for at least 14 days prior to randomization (Run- in period defined as Screening through TV1/Randomization).
- The index ulcer has a clean base and is free of necrotic debris at time of placement of treatment product.
Exclusion Criteria
- Subject has a known life expectancy of < 1 year.
- Index ulcer has been present for >1 year.
- Patient does not have adequate 2-week historical data demonstrating < 25% area reduction.
- Subject is unable to comply with offloading device.
- Presence of any condition(s) which seriously compromises the subject's ability to complete this study or has a known history of poor adherence to medical treatment.
- Subject has ulcers that are completely necrotic or fibrotic tissue.
- Subject has major uncontrolled medical disorders such as serious cardiovascular, renal, liver or pulmonary disease, lupus, palliative care or sickle cell anemia.
- Subject currently being treated for an active malignant disease or subjects with history of malignancy within the ulcer.
- The Subject has other concurrent conditions that in the opinion of the Principal Investigator may compromise subject safety.
- Known contraindications to acellular dermal matrices or known allergies to any of the Miro3D components.
- Concurrent participation in another clinical trial that involves an investigational drug or device that would interfere with this study.
- Index ulcer has reduced in area by ≥25% after 2 weeks of standard of care from the first screening visit (S1) to the TV1/randomization visit.
- Subject is pregnant or breastfeeding.
- Subjects with a history of more than two weeks treatment with immunosuppressants (including systemic corticosteroids >10mg daily dose), cytotoxic chemotherapy, or application of topical steroids to the ulcer surface within 30 days prior to randomization visit or who receive such medications during the screening period, or who are anticipated to require such medications during the course of the study.
- Index ulcer has been previously treated with tissue engineered materials (e.g. Apligraf® or Dermagraft®) or other scaffold materials (e.g. Oasis, Matristem) including any other CAMP within the last 30 days preceding the first treatment visit.
- Affected extremity requiring hyperbaric oxygen during the trial or within 2 weeks of screening visit 1.
- Presence of diabetes with poor metabolic control as documented with an HbA1c ≥12.0 within 30 days of randomization (TV1).
- Index ulcer and/or index limb with presence of gangrene or unstable ischemia at screening (SV1).
- Revascularization surgery on the lower extremity on which the index ulcer is located within 30 days of Screening Visit (SV1).
- Index ulcer in the opinion of the Principal Investigator, is suspicious for cancer and should undergo an ulcer biopsy to rule out a neoplasm of the ulcer.
- Any clinically significant finding, in the judgment of the Principal Investigator, that would place the subject at health risk, impact the study, or affect the completion of the study.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
팔의 수
무기와 개입
참가자 그룹 / 팔참가자 그룹 / 팔 |
개입 / 치료개입 / 치료 |
|---|---|
|
실험적: 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.
|
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 includes sharp debridement, offloading using a protocol-defined device, and appropriate moisture-retentive dressings.
|
|
활성 비교기: 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.
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Standard of care includes sharp debridement, offloading using a protocol-defined device, and appropriate moisture-retentive dressings.
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연구는 무엇을 측정합니까?
주요 결과 측정
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Proportion of Participants Achieving Complete Wound Closure of the Target Diabetic Foot Ulcer at 12 Weeks
기간: Up to 12 weeks
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Complete wound closure is defined as full re-epithelialization of the target ulcer without drainage or need for dressing, with closure confirmed at a single healing confirmation visit conducted approximately two weeks after complete closure is initially documented.
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Up to 12 weeks
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Mean Percentage Reduction in Target Ulcer Surface Area From Baseline to 12 Weeks
기간: Baseline through 12 weeks
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Percentage area reduction (PAR) is defined as the percent change in surface area of the target ulcer from baseline, as measured by digital planimetry.
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Baseline through 12 weeks
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2차 결과 측정
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Mean Change From Baseline in Ulcer-Associated Pain Score Assessed by Numeric Pain Rating Scale (NPRS)
기간: Baseline through 12 weeks
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Ulcer-associated pain will be assessed using the Numeric Pain Rating Scale (NPRS), a patient-reported scale ranging from 0 (no pain) to 10 (worst possible pain).
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Baseline through 12 weeks
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Number of Participants Experiencing Treatment-Emergent Adverse Events
기간: Up to 12 weeks
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Treatment-emergent adverse events will be collected and coded throughout the study period and summarized by treatment group.
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Up to 12 weeks
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기타 결과 측정
기타 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Change From Baseline in Tissue Oxygenation (StO₂) Values at Technology-Enabled Sites
기간: Baseline through 12 weeks
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Exploratory assessment of change from baseline in tissue oxygenation (StO₂) values measured using imaging technology at technology-enabled study sites.
Outcome data will include longitudinal changes in measured StO₂ values collected during the study period.
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Baseline through 12 weeks
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Change From Baseline in Fluorescence Imaging Signal Values at Technology-Enabled Sites
기간: Baseline through Week 12
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Exploratory assessment of change from baseline in fluorescence imaging signal values measured using imaging technology at technology-enabled study sites.
Outcome data will include longitudinal changes in measured fluorescence imaging signal values collected during the study period.
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Baseline through Week 12
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공동 작업자 및 조사자
연구 기록 날짜
연구 주요 날짜
연구 시작 (추정된)
연구 시작
기본 완료 (추정된)
기본 완료
연구 완료 (추정된)
연구 완료
연구 등록 날짜
최초 제출
최초 제출
QC 기준을 충족하는 최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
처음 게시됨
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
마지막 업데이트 게시됨
QC 기준을 충족하는 마지막 업데이트 제출
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
키워드
추가 관련 MeSH 약관
기타 연구 ID 번호
기타 연구 ID 번호
- RB-FOCUS3D-DFU
- IRB Tracking Number: 20261327 (기타 식별자: WCG)
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 계획 설명
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
미국에서 제조되어 미국에서 수출되는 제품
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Miro3D Wound Matrix에 대한 임상 시험
-
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