Phase IV Study to Evaluate the Efficacy of AMNIOEXCEL in Diabetic Foot Ulcers
A Multicenter, Prospective, Randomized, Parallel-group, Standard of Care-controlled Clinical Trial to Evaluate the Use of AMNIOEXCEL® in the Management of Chronic Diabetic Foot Ulcers
調査の概要
詳細な説明
Potential study candidates will be Screened for Inclusion and Exclusion criteria after providing informed consent. Candidates will have their wound cleansed and debrided (if necessary), photographed and measured. Blood will be drawn for laboratory analyses. Patients will return two weeks later for assessment.
Upon return, per the original protocol, patient would have been randomized at <20% closure; per Amendment 1, if the wound has closed <30% in area during the 2 week Screening Period and all other eligibility criteria are met, the patient will be randomized (1:1) to receive either AMNIOEXCEL® with Standard of Care (SOC) or SOC alone.
All patients enrolled in this study will receive SOC. For the purposes of this study, Standard of Care (SOC) includes debridement of necrotic/non-viable tissue, moist wound dressings, off-loading (where appropriate, DH Walker only) and infection surveillance and management. For those randomized to receive AMNIOEXCEL®, in addition to SOC, the tissue will be applied after the wound has been debrided and hemostasis achieved. The wound will then be dressed with a non-adherent dressing (e.g. Adaptic) and covered with a moisture retentive dressing.
The patient will return once weekly for wound care, photographs and ulcer measurement. At each visit, the wound will be assessed and AMNIOEXCEL® reapplied as appropriate, based upon physician judgment. All patients complete their participation at Week 6.
This is an open label study and no attempt will be made to blind subjects or Investigators to randomization allocation.
研究の種類
入学 (実際)
段階
- 適用できない
連絡先と場所
研究場所
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-
Arizona
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Phoenix、Arizona、アメリカ、85015
- Associated Foot and Ankle Specialists, LLC
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California
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Castro Valley、California、アメリカ、94546
- Center for Clinical Research, Inc.
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Stockton、California、アメリカ、95204
- Pacific Wound Center
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Florida
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Jacksonville、Florida、アメリカ、32216
- First Coast Cardiovascular Institute
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North Miami Beach、Florida、アメリカ、33169
- Barry University Clinical Research
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Massachusetts
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Plymouth、Massachusetts、アメリカ、02360
- Beth Israel Deaconess Hospital - Plymouth
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North Carolina
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Durham、North Carolina、アメリカ、27710
- Duke University
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Goldsboro、North Carolina、アメリカ、27533
- Wayne Memorial Hospital
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-
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
Inclusion Criteria:
- an ambulatory person at least 18 years of age at the time of informed consent.
- type 1 or type 2 diabetes mellitus.
- glycosylated hemoglobin (HbA1c) of ≤12%
at least one wound that is/has:
- Wagner grade 1 or superficial 2 (without bone, tendon or joint exposure),
- duration of at least 1 month,
- no clinical signs of infection or osteomyelitis,
- between 1cm2 and 25cm2 in area,
- per original protocol, closed <20% in area during the Screening Period; per Amendment #1, closed <30% in area during Screening and
- located on the foot, distal to malleoli.
- adequate circulation to the affected extremity
- serum creatinine of <3.0mg/dl.
Exclusion Criteria:
- participated in another clinical trial within 30 days prior to consent,
- Active Charcot deformity of the study foot (i.e. erythematous, warm, edematous and actively remodeling)
- receiving radiation or chemotherapy of any kind,
- known or suspected malignancy of current ulcer,
- pregnant or breast feeding,
- an active malignant disease,
- receiving hemo- or peritoneal dialysis,
- sickle cell anemia or Raynaud's syndrome,
- diagnosis of autoimmune connective tissue disease,
- received a biologic agent, growth factor, xenograft or skin equivalent in the 30 days prior to consent,
- exposed bone, tendon or joint capsule in the study ulcer,
- currently receiving antibiotics (for any reason), or
- taking medications considered to be immune system modulators.
研究計画
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 |
|---|---|
|
アクティブコンパレータ：AMNIOEXCEL
Human Amniotic Membrane Allograft
|
Application of AMNIOEXCEL every 1-2 weeks for a period of 6 weeks or until wound closure, whichever is sooner.
Advanced wound care dressings and offloading applied daily for a period of 8 weeks or until wound closure
|
|
アクティブコンパレータ：Standard of Care, Diabetic Foot Ulcers
Advanced wound care dressings and offloading of wound.
|
Advanced wound care dressings and offloading applied daily for a period of 8 weeks or until wound closure
|
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 |
時間枠 |
|---|---|
|
Proportion of patients with complete wound closure (i.e. complete skin re-epithelialization without drainage or dressing requirements) at 6 weeks after initiation of study treatment
時間枠：8 weeks
|
8 weeks
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Time to complete wound closure of the target ulcer
時間枠：8 weeks
|
8 weeks
|
|
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Rate of wound closure
時間枠：8 Weeks
|
8 Weeks
|
|
|
Incidence, severity and type of adverse events
時間枠：8 Weeks
|
This outcome measure represents a composite of collected adverse event data.
|
8 Weeks
|
|
Changes in Quality of Life assessment
時間枠：8 Weeks
|
8 Weeks
|
協力者と研究者
出版物と役立つリンク
研究記録日
主要日程の研究
研究開始
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (見積もり)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
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