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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)

2026年6月17日 更新者: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.

研究概览

详细说明

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

研究类型

介入性

注册 (估计的)

2000

阶段

  • 第四阶段

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习联系方式

研究联系人备份

学习地点

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 成人
  • 年长者

接受健康志愿者

不

描述

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.

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:治疗
  • 分配:随机化
  • 介入模型:并行分配
  • 屏蔽:无(打开标签)

武器和干预

参与者组/臂
干预/治疗
实验性的: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.
实验性的: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.
实验性的: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.
实验性的: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.
实验性的: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.

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Between Arm Difference for Complete Closure
大体时间: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

次要结果测量

结果测量
措施说明
大体时间
Time to Closure
大体时间: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
大体时间: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
大体时间: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
大体时间: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

其他结果措施

结果测量
措施说明
大体时间
Evaluate Quality of Life
大体时间: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
大体时间: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
大体时间: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
大体时间:0-20 Weeks
Selected sites only: to demonstrate durability of closure (rate of recurrence) of subjects with a closed ulcer.
0-20 Weeks

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

合作者

调查人员

  • 首席研究员:Thomas Serena, MD、Serena Group

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2026年1月28日

初级完成 (估计的)

2028年1月28日

研究完成 (估计的)

2028年1月28日

研究注册日期

首次提交

2026年5月21日

首先提交符合 QC 标准的

2026年6月17日

首次发布 (实际的)

2026年6月24日

研究记录更新

最后更新发布 (实际的)

2026年6月24日

上次提交的符合 QC 标准的更新

2026年6月17日

最后验证

2026年6月1日

更多信息

与本研究相关的术语

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

不

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

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