VLU Non-Inferiority Study Comparing a Dual Action Pneumatic Compression Device to Multi-Layer Bandaging
2020年2月11日 更新者：Tactile Medical
Randomized Trial Comparing a Dual Action Pneumatic Compression System Against Multi-Layer Bandaging Systems: A Non-Inferiority Study
The purpose of the study is to test non-inferiority of chronic Venous Leg Ulcer (VLU) area reduction at 16 weeks with a dual action pneumatic compression device compared to multi-layer bandaging.
調査の概要
詳細な説明
Participants with a chronic venous leg ulcer will participate in a 2 week run in phase using standard of care multi-layer bandaging before being randomly assigned to either treatment using a dual action pneumatic compression device or continued multi-layer bandaging for up to 16 weeks.
Participants will be seen in clinic for treatment and evaluation of symptoms and quality of life.
研究の種類
介入
入学 (実際)
56
段階
- 適用できない
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。
研究場所
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Arizona
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Phoenix、Arizona、アメリカ、85012
- Phoenix VA Health Care System
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Phoenix、Arizona、アメリカ、85015
- Associated Foot and Ankle Specialists, LLC
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Tucson、Arizona、アメリカ、85710
- Arizona Regional Medical Research
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California
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Carlsbad、California、アメリカ、92009
- ILD Research Center
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Fresno、California、アメリカ、93720
- Limb Preservation Platform - Northwest
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Fresno、California、アメリカ、93721
- Limb Preservation Platform - Downtown
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Long Beach、California、アメリカ、90822
- Long Beach VA Healthcare System
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Los Angeles、California、アメリカ、90024
- UCLA Medical Center
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Los Angeles、California、アメリカ、90073
- Greater Los Angeles VA Healthcare System
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San Diego、California、アメリカ、92161
- VA San Diego Healthcare System
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Sylmar、California、アメリカ、91342
- Olive View - UCLA Medical Center
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Florida
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Miami、Florida、アメリカ、33136
- University of Miami
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North Miami Beach、Florida、アメリカ、33169
- Barry University Clinical Research
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South Miami、Florida、アメリカ、33143
- Foot and Ankle Institute of South Florida
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Massachusetts
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Boston、Massachusetts、アメリカ、02118
- Boston Medical Center
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New York
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Stony Brook、New York、アメリカ、11794
- Stony Brook University
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North Carolina
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Chapel Hill、North Carolina、アメリカ、27599
- UNC School of Medicine
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Ohio
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Toledo、Ohio、アメリカ、43606
- Jobst Vascular Institute
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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
18年歳以上 (大人、高齢者)
健康ボランティアの受け入れ
いいえ
受講資格のある性別
全て
説明
Inclusion Criteria:
- Subject must be ≥ 18 years of age or legal age at the time of enrollment.
- Chronic venous insufficiency confirmed by ultrasound within previous 12 months or prior to randomization: if subject had bilateral CVI, the limb that possessed the largest ulcer meeting study criteria was used as the study treatment limb for evaluation and documentation throughout the study. Non-study limbs received standard of care treatment as determined by the treating clinician.
- Must have at least one of the following within the past six (6) months: Dorsalis Pedis (DP) systolic pressure ≥ 80mmHg for diabetic patients or ≥ 60mmHg for non-diabetic patients on study limb; Posterior Tibial (PT) systolic pressure ≥ 80mmHg for diabetic patients or ≥ 60mmHg for non-diabetic patients on study limb; Transcutaneous partial pressure oxygen (TcP02) > 30mmHg; Great toe systolic pressure > 40mmHg.
- Active ulceration (CEAP classification of C6): VLU was defined by open skin lesion of the leg or foot that occurred in an area affected by venous hypertension.
- Ulcer duration: Non healing VLU ≥ 1 month but not greater than 24 months.
- Ulcer size ≥ 2cm² ≤ 50cm²: if there were multiple ulcers on the study limb, the largest ulcer was used as the study treatment ulcer for evaluation and documentation throughout the study. If two ulcers were separated by no more than one centimeter of normal skin, their areas were added together for study purposes.
- Three or fewer separate full thickness ulcers on the study limb: sum of the ulcer areas on the study limb must be ≤ 50 cm².
- Leg circumferences within the following range: Ankle - 12 to 44cm; Calf - 22 to 60cm; Below knee - 22 to 68cm.
- Able and willing to provide informed consent prior to study participation.
Exclusion Criteria:
- Target ulcer or any other ulcer on the study limb involves exposure of tendon, muscle, or bone.
- Target ulcer was of non-venous etiology (sickle cell anemia, necrobiosis lipoidica diabeticorum, pyoderma, malignancy).
- Treatment of the target ulcer with living cellular therapy within 30 days of the time of projected randomization.
- Endovenous ablation or other venous surgery within two weeks of enrollment: venous ultrasound must be completed after procedure to determine whether there is still venous insufficiency at the time of enrollment.
- History of skin sensitivity to any of the components of ACT, multi-layer bandages of compression garments.
- History of an acute deep vein thrombosis (DVT) or pulmonary embolism (PE) within the last three (3) months.
- Acute thrombophlebitis within the last six (6) weeks.
- History of pulmonary edema or decompensated congestive heart failure within six (6) weeks of screening.
- Currently has an active infection of the skin on the target limb such as cellulitis requiring antibiotics.
- History of target limb cancer within the last 2 years with the exception of treated non-melanoma skin cancer unless ulcer biopsy performed at screening is negative for neoplasia.
- Active cancer receiving chemotherapy and/or radiation therapy.
- Poorly controlled diabetes with an HbA1c value of > 12% within the past three (3) months.
- Changes to medications that affected edema within the last 30 days prior to enrollment (e.g., diuretics, calcium channel blockers of the dihyropyridine class, pioglitazone, cox-1 inhibitors, pregabalin, and gabapentin, diltiazem, or fluctuating doses of systemic steroids).
- Use of systemic corticosteroids requiring daily administration at doses greater than 5mg of Prednisone per day or equivalent for greater than 2 weeks: low dose steroid administration (Prednisone up to 5 mg per day or equivalent) was allowable for an unlimited period of time. Topical steroid administration to peri-ulcer area or other skin was allowable but could not be applied to the ulcer itself.
- Currently pregnant or trying to become pregnant.
- Inability or unwillingness to participate in all aspects of study protocol.
- Exhibited any condition which, according to the Investigator, justified the subject's exclusion from the study, such as a medical condition where an increase in venous or lymphatic return is undesirable.
- Currently participating in another clinical trial.
Additional Exclusion Criteria after two week run-in:
- Subject's target ulcer decreased in size by greater than 30% compared to the baseline area.
- Subject's target ulcer increased in size by greater than 50% compared to the baseline area.
- Subject's target ulcer measured less than 1.5cm² at the Randomization Visit.
- Subject appeared to have evidence of infection in any ulcer.
- The sum of the ulcer areas on the subject's study limb is > 50cm².
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：Dual Action Pneumatic Compression Device
ACTitouch dual action pneumatic compression system used daily during wakeful hours for up to 16 weeks.
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Dual action pneumatic compression device used to treat chronic VLUs.
他の名前：
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アクティブコンパレータ：Multi-layer bandaging
PROFORE or Coban 2 to be worn 24 hours daily for up to 16 weeks.
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Multi-layer bandaging used to treated chronic VLUs
他の名前：
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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 |
|---|---|---|
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Percentage of VLU Area Reduction
時間枠：Changes from Baseline to 16 weeks
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Percentage of ulcer area reduction in the target VLU during the 16 week treatment period calculated by wound imaging software.
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Changes from Baseline to 16 weeks
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Patient-Reported Quality of Life
時間枠：Changes from Baseline to 16 weeks
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The Charing Cross Venous Ulcer Questionnaire assesses the patients' perception of their health when venous ulceration is present.
All items are scored so that a lower score defines a more favorable health state (a greater reduction is associated with improved quality of life).
In addition, each item is scored using a 1 to 5 range so that the lowest and highest possible scores are 0 and 100, respectively.
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Changes from Baseline to 16 weeks
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Outpatient Costs
時間枠：Changes from Baseline to 16 weeks
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Assessment of the effect of the Actitouch compared to a standard regimen of multi-layer bandaging on mean total outpatient costs per subject.
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Changes from Baseline to 16 weeks
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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。
スポンサー
捜査官
- 主任研究者：William Marston, MD、University of North Carolina, Chapel Hill
出版物と役立つリンク
研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。
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)
2016年2月1日
一次修了 (実際)
2017年5月1日
研究の完了 (実際)
2017年6月1日
試験登録日
最初に提出
2016年2月9日
QC基準を満たした最初の提出物
2016年2月11日
最初の投稿 (見積もり)
2016年2月12日
学習記録の更新
投稿された最後の更新 (実際)
2020年2月19日
QC基準を満たした最後の更新が送信されました
2020年2月11日
最終確認日
2020年1月1日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。