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.
調査の概要
状態
募集
詳細な説明
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
研究の種類
介入
入学 (推定)
2000
段階
- フェーズ 4
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究連絡先
- 名前:Bennett Sarver
- 電話番号:1-833-865-6300
- メール:info@serenagroups.com
研究連絡先のバックアップ
- 名前:Amy Allen
- 電話番号:1-833-865-6300
- メール:info@serenagroups.com
研究場所
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-
Ohio
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North Royalton、Ohio、アメリカ、44133
- 募集
- Amber Stormer
-
コンタクト:
- Amber Stormer, Admin
- 電話番号:440-652-8748
- メール:astormer@encoreclinicalservices.com
-
-
参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
いいえ
説明
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.
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか?
デザインの詳細
- 主な目的:処理
- 割り当て:ランダム化
- 介入モデル:並列代入
- マスキング:なし(オープンラベル)
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的: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.
|
|
実験的: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.
|
|
実験的: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.
|
|
実験的: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.
|
|
実験的: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.
|
この研究は何を測定していますか?
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Between Arm Difference for Complete Closure
時間枠: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
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Time to Closure
時間枠: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
時間枠: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
時間枠: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
時間枠: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
|
その他の成果指標
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Evaluate Quality of Life
時間枠: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
時間枠: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
時間枠: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
時間枠:0-20 Weeks
|
Selected sites only: to demonstrate durability of closure (rate of recurrence) of subjects with a closed ulcer.
|
0-20 Weeks
|
協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (実際)
2026年1月28日
一次修了 (推定)
2028年1月28日
研究の完了 (推定)
2028年1月28日
試験登録日
最初に提出
2026年5月21日
QC基準を満たした最初の提出物
2026年6月17日
最初の投稿 (実際)
2026年6月24日
学習記録の更新
投稿された最後の更新 (実際)
2026年6月24日
QC基準を満たした最後の更新が送信されました
2026年6月17日
最終確認日
2026年6月1日
詳しくは
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