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

29. Juni 2021 aktualisiert von: 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.

Studienübersicht

Status

Abgeschlossen

Bedingungen

Intervention / Behandlung

Detaillierte Beschreibung

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.

Studientyp

Interventionell

Einschreibung (Tatsächlich)

21

Phase

  • Unzutreffend

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienorte

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

18 Jahre und älter (Erwachsene, Älterer Erwachsener)

Akzeptiert gesunde Freiwillige

Nein

Studienberechtigte Geschlechter

Alle

Beschreibung

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

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Behandlung
  • Zuteilung: Zufällig
  • Interventionsmodell: Parallele Zuordnung
  • Maskierung: Keine (Offenes Etikett)

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Experimental: pneumatic compression - 1 hour per day
Pneumatic compression device - 12 consecutive days undergoing a 1 hour treatment regimen.
Gerät: pneumatic compression - 1 hour per day
Pneumatic compression treatment once per day (1 hour)
Andere Namen:
  • Flexitouch pump
  • Flexitouch device
Experimental: 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.
Gerät: pneumatic compression - 2 hours per day
pneumatic compression treatment twice per day in the AM & PM (2 hours)
Andere Namen:
  • Flexitouch pump
  • Flexitouch device
Experimental: 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)
Gerät: 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)
Andere Namen:
  • Flexitouch pump
  • Flexitouch device

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Limb Volume (ml)
Zeitfenster: 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)
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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)

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Cellular Fluid Changes (Ohms)
Zeitfenster: 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)
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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)

Andere Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Change in Skin Thickness
Zeitfenster: 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)
Zeitfenster: 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)

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

Tactile Medical

Ermittler

  • Hauptermittler: Vaughan Keeley, PhD, FRCP, Royal Derby Hospital

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Tatsächlich)

11. November 2013

Primärer Abschluss (Tatsächlich)

31. März 2019

Studienabschluss (Tatsächlich)

30. Juni 2019

Studienanmeldedaten

Zuerst eingereicht

7. Januar 2014

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

7. Januar 2014

Zuerst gepostet (Schätzen)

9. Januar 2014

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

20. Juli 2021

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

29. Juni 2021

Zuletzt verifiziert

1. Juni 2021

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Schlüsselwörter

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • 4010 FlexDose

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