このページは自動翻訳されたものであり、翻訳の正確性は保証されていません。を参照してください。 英語版 ソーステキスト用。

Treatment Response to Different Lymphoedema Compression Programs Using a Pneumatic Compression Device

2021年6月29日 更新者：Tactile Medical

Physiologic Response to Varying Lymphoedema Compression Programs With the Flexitouch System

Proof of principle study in order to determine if there is a difference in treatment effect across the 3 study groups when treating lower extremity lymphoedema using a pneumatic compression device.

調査の概要

状態

完了

条件

介入・治療

詳細な説明

This is a single center, 3 arm, prospective, randomized, clinical trial to assess the difference between 3 treatment options for achieving a measurable physiologic effect on lower extremity lymphedema with pneumatic compression device. Each intervention arm will include 10 completed subjects for a total of 30 completed subjects.

研究の種類

介入

入学 (実際)

21

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

  • イギリス
      • Derby、イギリス、DE22 3NE
        • Royal Derby Hospital

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:

  • Subjects must be ≥ 18 years old
  • Subjects must have a diagnosis of primary or secondary Stage 2 unilateral or bilateral lower extremity lymphoedema
  • Must currently be using adequate compression garment(s) as determined by the clinician: (Garments must be at least 20mmHg and no more than 3 months old and must be worn upon rising and removed at bedtime)
  • Subjects must have clinically relevant excess limb swelling as determined by clinician "pitting test"
  • Must be able to attend all required in-clinic treatment visits

Exclusion Criteria:

  • Diagnosis of active or recurrent cancer, or less than 3 months at the time of initial evaluation from the completion of chemotherapy, radiation therapy, or primary surgery for the treatment of cancer
  • Active infection or inflammation
  • Active thrombophlebitis (within the last 2 months)
  • History of pulmonary embolism (within the last 2 months)
  • Documented history of deep chronic venous insufficiency or deep venous obstruction with a reflux duration of > 2 second in the deep system or any history of deep vein thrombosis (DVT)
  • History of pulmonary edema
  • History of congestive heart failure
  • History of chronic kidney disease with a glomerular filtration rate (GFR) of less than 30 mls per minute
  • Poorly controlled asthma
  • Symptomatic or severe peripheral artery disease (defined by current lifestyle-limiting claudication or critical limb ischemia)
  • Presence of an open wound or ulcer of any etiology
  • Diagnosis of lipoedema and lipolymphoedema
  • Currently using an in-home pneumatic compression device
  • Metal implant(s) that would interfere with bioimpedance equipment
  • Pacemaker or other implanted electronic device(s)
  • Unable or unwilling to remove bandaging from treatment regimen while participating in the study
  • Pregnant
  • Any condition where increased venous and lymphatic return is undesirable
  • Unable or unwilling to participate in all aspects of the study protocol and/or unable to provide informed consent
  • Currently participating in another clinical trial
  • Currently using diuretics
  • BMI > 40

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：pneumatic compression - 1 hour per day
Pneumatic compression device - 12 consecutive days undergoing a 1 hour treatment regimen.
デバイス：pneumatic compression - 1 hour per day
Pneumatic compression treatment once per day (1 hour)
他の名前：
  • Flexitouch pump
  • Flexitouch device
実験的：pneumatic compression - 2 hours per day
Pneumatic compression device - 5 consecutive days undergoing 1 hour treatment in the am and 1 hour of treatment in the pm.
デバイス：pneumatic compression - 2 hours per day
pneumatic compression treatment twice per day in the AM & PM (2 hours)
他の名前：
  • Flexitouch pump
  • Flexitouch device
実験的：pneumatic compression - 4 hours per day
Pneumatic compression device - 5 consecutive days undergoing treatment twice per day consisting of 2 consecutive 1 hour treatments in the am and the pm (4 hours total)
デバイス：pneumatic compression - 4 hours per day
pneumatic compression treatment twice per day consisting of 2 consecutive 1 hour treatments in the AM & PM (4 hours)
他の名前：
  • Flexitouch pump
  • Flexitouch device

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
Limb Volume (ml)
時間枠：Change baseline to final day (day 12 for Group A and day 5 for Groups B and C)
Limb volume changes measured via perometry reported in change of ml of fluid. A negative value is associated with the clinically-desirable decrease in fluid.
Change baseline to final day (day 12 for Group A and day 5 for Groups B and C)
Limb Volume (% Change)
時間枠：Change baseline to final day (day 12 for Group A and day 5 for Groups B and C)
Limb volume changes measured via perometry reported in percent reduction. A negative value is associated with the clinically-desirable decrease in fluid.
Change baseline to final day (day 12 for Group A and day 5 for Groups B and C)
Change in Skin Tone
時間枠：Change baseline to final day (day 12 for Group A and day 5 for Groups B and C)
Change in skin tone (fibrosis) measured via tonometry. The tonometer is a mechanical device that gives an indication of the resistance of tissue to compression. It is used in lymphedema to give an estimate of the extent of pitting and fibrotic induration. Tonometry measures were collected at 5 anatomical locations. A negative value is associated with a clinically desirable decrease in tone.
Change baseline to final day (day 12 for Group A and day 5 for Groups B and C)
Patient Reported Outcomes - MYMOP
時間枠：Change baseline to final day (day 12 for Group A and day 5 for Groups B and C)

Changes in patient-determined symptoms* and change in affect the symptoms had on the subject. Measured via MYMOP (Measure Yourself Medical Outcome Profile) questionnaire. A low score indicates a good outcome. Scores range from 0 (as good as can be) to 6 (as bad as can be).

*Recorded symptoms were: Gr A, 1st symptom: none, abdominal pain and discomfort, swelling, physical, and worrying about granddaughters Gr B, 1st symptom: arthritis, hayfever, look of fat foot, right hand area of neck and shoulder, stairs, and swelling Gr C, 1st symptom: none, energy during dancing and gardening, frustration of not going out on own, swelling, mild longstanding depression, and MPT joint at base of small toe Gr A, 2nd symptom: fatigue, heaviness of leg, mental, and pain under knee Gr B, 2nd symptom: narrowed choice of footwear, shower in bath, and swollen left foot Gr C, 2nd symptom: being tired and aching all over, and shoes and clothing
Change baseline to final day (day 12 for Group A and day 5 for Groups B and C)

二次結果の測定

結果測定
メジャーの説明
時間枠
Cellular Fluid Changes (Ohms)
時間枠：Change after initial treatment on day 1 and change baseline to end of day 5 for all groups
Changes in extra cellular fluid (ECF) on treated leg measured by bioimpedance. A negative number is indicative of a clinically desirable reduction in ECF.
Change after initial treatment on day 1 and change baseline to end of day 5 for all groups
Cellular Fluid Changes (% Change)
時間枠：Change after initial treatment on day 1 and change baseline to end of day 5 for all groups
Changes in extra cellular fluid (ECF) on treated leg measured by bioimpedance. A negative number is indicative of a clinically desirable reduction in ECF.
Change after initial treatment on day 1 and change baseline to end of day 5 for all groups
Incidence of Complications
時間枠：Change baseline to final day (day 12 for Group A and day 5 for Groups B and C)
Number of complications experienced. Incidence based on clinician assessment.
Change baseline to final day (day 12 for Group A and day 5 for Groups B and C)
Activity Level
時間枠：Day 1 compared to final treatment day (day 12 for Group A and day 5 for Groups B and C)
Change in number of steps as accumulated each day monitored through use of a pedometer. A positive number indicates an increase in step count (activity) while a negative number indicates a decrease in step count.
Day 1 compared to final treatment day (day 12 for Group A and day 5 for Groups B and C)

その他の成果指標

結果測定
メジャーの説明
時間枠
Change in Skin Thickness
時間枠：Change baseline to final day (day 12 for Group A and day 5 for Groups B and C)
Change in skin thickness measured by ultrasound. Ultrasound measures were collected at 5 anatomical locations. A negative value is associated with a clinically desirable reduction in skin thickness (a surrogate measure of oedema).
Change baseline to final day (day 12 for Group A and day 5 for Groups B and C)
Change in Local Tissue Water (LTW)
時間枠：Change baseline to final day (day 12 for Group A and day 5 for Groups B and C)
Change in local tissue water (LTW) within the skin measured by MoistureMeterD (MMD). MMD measures were collected at 5 anatomical locations using 2 probes: medium (M25) and large (L50). A negative value is associated with a clinically desirable decrease in LTW (a surrogate measure of oedema).
Change baseline to final day (day 12 for Group A and day 5 for Groups B and C)

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

Tactile Medical

捜査官

  • 主任研究者：Vaughan Keeley, PhD, FRCP、Royal Derby Hospital

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)

2013年11月11日

一次修了 (実際)

2019年3月31日

研究の完了 (実際)

2019年6月30日

試験登録日

最初に提出

2014年1月7日

QC基準を満たした最初の提出物

2014年1月7日

最初の投稿 (見積もり)

2014年1月9日

学習記録の更新

投稿された最後の更新 (実際)

2021年7月20日

QC基準を満たした最後の更新が送信されました

2021年6月29日

最終確認日

2021年6月1日

詳しくは

本研究に関する用語

キーワード

追加の関連 MeSH 用語

その他の研究ID番号

  • 4010 FlexDose

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。

購読する