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Study Title: A Multicenter, Prospective, Modified Platform Trial Evaluating Several Cellular, Acellular, and Matrix-like Products (CAMPs) and Standard of Care Versus Matched Standard of Care Controls in the Management of Nonhealing Pressure Ulcers. (RESTORE)

2026년 6월 17일 업데이트: Sequence LifeScience, Inc.
A multicenter prospective modified platform trial evaluating several cellular, acellular, and matrix like products and standard of care versus matched standard of care controls in the management of nonhealing pressure ulcers.

연구 개요

상세 설명

This study is a multi-center, prospective, modified platform trial consisting of 2,000 subjects from up to Up to 75 providers at up to 25 investigational sites. The subjects are randomized to receive 1 of 5 treatments, either with Activate™ Matrix (CAMP-1) and SOC; AmnioDefend™ FT Matrix (CAMP-2) and SOC; Palisade™ Matrix (CAMP-3) and SOC; Sentry™ SL Matrix (CAMP-4) and SOC; Shelter™ DM Matrix (CAMP-5) and SOC. The target ulcers are evaluated weekly by the investigator. The subject is treated once a week, to receive weekly applications of one of the five CAMPs + SOC or matched controls until or up to 20 weeks or until the study ulcer has completely closed (i.e. 100% closure as assessed by the investigator and confirmed 2 weeks later at the closure confirmation visit (CCV). One additional visit per week is optional, for the purpose of changing only the secondary dressing

연구 유형

중재적

등록 (추정된)

2000

단계

  • 4단계

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 연락처

연구 연락처 백업

연구 장소

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

  • 성인
  • 고령자

건강한 자원 봉사자를 받아들입니다

아니

설명

Inclusion Criteria:

  • The potential subject must be at least 18 years of age or older.
  • The potential subject must agree to attend the weekly study visits required by the protocol.
  • The potential subject must be willing and able to participate in the informed consent process.
  • The potential subject must have a full-thickness pressure ulcer NPIAP stage 3 or stage 4 without exposed tendon or bone of greater than or equal to one month in duration located on the trunk (sacral, trochanteric, or ischial).
  • At enrollment, the potential subject must have a target ulcer with a minimum surface area of 2 cm2 and a maximum surface area of 100cm2 measured post-debridement with the imaging device.
  • The potential subject has adequate off-loading of the ulcer

Exclusion Criteria:

  • The potential subject is known to have a life expectancy of < 3 months.
  • The potential subject's target ulcer is not a pressure ulcer.
  • The target ulcer is infected, requires systemic antibiotic therapy, or there is cellulitis in the surrounding skin.
  • The target ulcer exposes tendon or bone.
  • The target ulcer has undermining or tunneling.
  • There is evidence of osteomyelitis complicating the target ulcer.
  • The potential subject is receiving immunosuppressants (including systemic corticosteroids at doses greater than 10 mg of prednisone per day or equivalent) or cytotoxic chemotherapy or is taking medications that the PI believes will interfere with wound healing (e.g., biologics).
  • The potential subject has applied topical steroids to the ulcer surface within one month of initial screening.
  • The potential subject has glycated hemoglobin (HbA1c) greater than or equal to 12% within 3 months of the initial screening visit.
  • The surface area of the potential subject's target ulcer has reduced in size by more than 20% in the 2 weeks prior to the initial screening visit ("historical" run-in period). Imaging Device is not required for measurements taken during the historical run-in period (e.g., calculating surface area using length × width is acceptable).
  • The surface area measurement of the potential subject's target ulcer decreases by 25% or more during the active 2-week screening phase: the 2 weeks from the initial screening visit (S1) to the TV-1 visit during which time the potential subject received SOC. - The potential subject is a woman who is pregnant or considering becoming pregnant within the next 6 months.
  • The potential subject has end stage renal disease requiring dialysis.
  • The potential subject, in the opinion of the investigator, has a medical or psychological condition that may interfere with study assessments.
  • The potential subject was treated with hyperbaric oxygen therapy (HBOT) or a Cellular, Acellular, Matrix-like Product (CAMP) in the 30 days prior to the initial screening visit.
  • The potential subject has a malnutrition indicator score of <17 as measured on the Mini Nutritional Assessment.
  • Known hemoglobin of < 8 g/dL as this is an indicator of poor wound healing.

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 치료
  • 할당: 무작위
  • 중재 모델: 병렬 할당
  • 마스킹: 없음(오픈 라벨)

무기와 개입

참가자 그룹 / 팔
개입 / 치료
실험적: Activate™ Matrix + SOC
Three layers: amnion, intermediate layer, and chorion
Participants will receive weekly applications of Activate™ Matrix and Standard of Care until ulcer closure, or a maximum of 20 weeks, whichever occurs first.
실험적: AmnioDefend™ FT Matrix + SOC
Three layers: amnion, intermediate layer, and chorion
Participants will receive weekly applications of AmnioDefend™ FT Matrix and Standard of Care until ulcer closure, or a maximum of 20 weeks, whichever occurs first.
실험적: Palisade™ DM Matrix + SOC
Two layers: amnion and chorion
Participants will receive weekly applications of Palisade™ DM Matrix and Standard of Care until ulcer closure, or a maximum of 20 weeks, whichever occurs first.
실험적: Sentry™ SL Matrix + SOC
One layer: amnion
Participants will receive weekly applications of Sentry™ SL Matrix and Standard of Care until ulcer closure, or a maximum of 20 weeks, whichever occurs first.
실험적: Shelter™ DM Matrix + SOC
Two layers: amnion and chorion
Participants will receive weekly applications of Shelter™ DM Matrix and Standard of Care until ulcer closure, or a maximum of 20 weeks, whichever occurs first.

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Between Arm Difference for Complete Closure
기간: 0-20 Weeks
Determine the between-arm difference in the proportion of subjects achieving complete closure of nonhealing pressure ulcers with multiple CAMPs plus SOC versus matched SOC controls (mSOC) over 20 weeks using a modified platform trial design.
0-20 Weeks

2차 결과 측정

결과 측정
측정값 설명
기간
Time to Closure
기간: 0-20 Weeks
Determine the between-arm difference in the time to closure over 20 weeks for CAMP plus SOC versus mSOC.
0-20 Weeks
Percentage Area Reduction
기간: 0-20 Weeks
Determine the between-arm difference in the percent area reduction (PAR) at weekly intervals the CAMP plus SOC arms versus mSOC.
0-20 Weeks
Pain Scale Reduction
기간: 0-20 Weeks
Determine the between-arm difference in pain for patients that present with a Visual Analog Scale score of greater than 4. The scale is a rage of 0-10, 0 being no pain and 10 being worst pain imaginable.
0-20 Weeks
Adverse Events
기간: 0-20 Weeks
Evaluate the between-arm difference in the frequency and nature of adverse events in subjects receiving CAMP plus SOC versus mSOC.
0-20 Weeks

기타 결과 측정

결과 측정
측정값 설명
기간
Evaluate Quality of Life
기간: 0-20 Weeks
Evaluate the between-arm difference in the quality of life for subjects receiving CAMP plus SOC compared to SOC only using the Forgotten Wound Score (FWS) at treatment visits 1, 4, 8, 12, 16, and 20.
0-20 Weeks
Compliance with Off-loading
기간: 0-20 Weeks
To determine compliance with off-loading and the effect on wound closure.
0-20 Weeks
Ulcers to Close in Patients over 65
기간: 0-20 Weeks
To determine the proportion of ulcers that close in patients 65 years or older for CAMP plus SOC versus mSOC.
0-20 Weeks
Rate of Reoccurrence
기간: 0-20 Weeks
Selected sites only: to demonstrate durability of closure (rate of recurrence) of subjects with a closed ulcer.
0-20 Weeks

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

협력자

수사관

  • 수석 연구원: Thomas Serena, MD, Serena Group

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (실제)

2026년 1월 28일

기본 완료 (추정된)

2028년 1월 28일

연구 완료 (추정된)

2028년 1월 28일

연구 등록 날짜

최초 제출

2026년 5월 21일

QC 기준을 충족하는 최초 제출

2026년 6월 17일

처음 게시됨 (실제)

2026년 6월 24일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2026년 6월 24일

QC 기준을 충족하는 마지막 업데이트 제출

2026년 6월 17일

마지막으로 확인됨

2026년 6월 1일

추가 정보

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