Treatment Response to Different Lymphoedema Compression Programs Using a Pneumatic Compression Device
29 czerwca 2021 zaktualizowane przez: 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.
Przegląd badań
Status
Zakończony
Szczegółowy opis
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.
Typ studiów
Interwencyjne
Zapisy (Rzeczywisty)
21
Faza
- Nie dotyczy
Kontakty i lokalizacje
Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.
Lokalizacje studiów
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Derby, Zjednoczone Królestwo, DE22 3NE
- Royal Derby Hospital
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Kryteria uczestnictwa
Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.
Kryteria kwalifikacji
Wiek uprawniający do nauki
18 lat i starsze (Dorosły, Starszy dorosły)
Akceptuje zdrowych ochotników
Nie
Płeć kwalifikująca się do nauki
Wszystko
Opis
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
Plan studiów
Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Leczenie
- Przydział: Randomizowane
- Model interwencyjny: Przydział równoległy
- Maskowanie: Brak (otwarta etykieta)
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
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Eksperymentalny: pneumatic compression - 1 hour per day
Pneumatic compression device - 12 consecutive days undergoing a 1 hour treatment regimen.
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Pneumatic compression treatment once per day (1 hour)
Inne nazwy:
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Eksperymentalny: 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.
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pneumatic compression treatment twice per day in the AM & PM (2 hours)
Inne nazwy:
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Eksperymentalny: 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)
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pneumatic compression treatment twice per day consisting of 2 consecutive 1 hour treatments in the AM & PM (4 hours)
Inne nazwy:
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Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
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Limb Volume (ml)
Ramy czasowe: Change baseline to final day (day 12 for Group A and day 5 for Groups B and C)
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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.
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Change baseline to final day (day 12 for Group A and day 5 for Groups B and C)
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Limb Volume (% Change)
Ramy czasowe: Change baseline to final day (day 12 for Group A and day 5 for Groups B and C)
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Limb volume changes measured via perometry reported in percent reduction.
A negative value is associated with the clinically-desirable decrease in fluid.
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Change baseline to final day (day 12 for Group A and day 5 for Groups B and C)
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Change in Skin Tone
Ramy czasowe: Change baseline to final day (day 12 for Group A and day 5 for Groups B and C)
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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.
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Change baseline to final day (day 12 for Group A and day 5 for Groups B and C)
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Patient Reported Outcomes - MYMOP
Ramy czasowe: Change baseline to final day (day 12 for Group A and day 5 for Groups B and C)
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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)
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Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
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Cellular Fluid Changes (Ohms)
Ramy czasowe: Change after initial treatment on day 1 and change baseline to end of day 5 for all groups
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Changes in extra cellular fluid (ECF) on treated leg measured by bioimpedance.
A negative number is indicative of a clinically desirable reduction in ECF.
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Change after initial treatment on day 1 and change baseline to end of day 5 for all groups
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Cellular Fluid Changes (% Change)
Ramy czasowe: Change after initial treatment on day 1 and change baseline to end of day 5 for all groups
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Changes in extra cellular fluid (ECF) on treated leg measured by bioimpedance.
A negative number is indicative of a clinically desirable reduction in ECF.
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Change after initial treatment on day 1 and change baseline to end of day 5 for all groups
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Incidence of Complications
Ramy czasowe: Change baseline to final day (day 12 for Group A and day 5 for Groups B and C)
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Number of complications experienced.
Incidence based on clinician assessment.
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Change baseline to final day (day 12 for Group A and day 5 for Groups B and C)
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Activity Level
Ramy czasowe: Day 1 compared to final treatment day (day 12 for Group A and day 5 for Groups B and C)
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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.
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Day 1 compared to final treatment day (day 12 for Group A and day 5 for Groups B and C)
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Inne miary wyników
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
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Change in Skin Thickness
Ramy czasowe: Change baseline to final day (day 12 for Group A and day 5 for Groups B and C)
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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).
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Change baseline to final day (day 12 for Group A and day 5 for Groups B and C)
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Change in Local Tissue Water (LTW)
Ramy czasowe: Change baseline to final day (day 12 for Group A and day 5 for Groups B and C)
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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).
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Change baseline to final day (day 12 for Group A and day 5 for Groups B and C)
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Współpracownicy i badacze
Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.
Sponsor
Śledczy
- Główny śledczy: Vaughan Keeley, PhD, FRCP, Royal Derby Hospital
Daty zapisu na studia
Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.
Główne daty studiów
Rozpoczęcie studiów (Rzeczywisty)
11 listopada 2013
Zakończenie podstawowe (Rzeczywisty)
31 marca 2019
Ukończenie studiów (Rzeczywisty)
30 czerwca 2019
Daty rejestracji na studia
Pierwszy przesłany
7 stycznia 2014
Pierwszy przesłany, który spełnia kryteria kontroli jakości
7 stycznia 2014
Pierwszy wysłany (Oszacować)
9 stycznia 2014
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
20 lipca 2021
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
29 czerwca 2021
Ostatnia weryfikacja
1 czerwca 2021
Więcej informacji
Terminy związane z tym badaniem
Słowa kluczowe
Dodatkowe istotne warunki MeSH
Inne numery identyfikacyjne badania
- 4010 FlexDose
Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .