Treatment Response to Different Lymphoedema Compression Programs Using a Pneumatic Compression Device
29. června 2021 aktualizováno: 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.
Přehled studie
Postavení
Dokončeno
Detailní popis
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 studie
Intervenční
Zápis (Aktuální)
21
Fáze
- Nelze použít
Kontakty a umístění
Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.
Studijní místa
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Derby, Spojené království, DE22 3NE
- Royal Derby Hospital
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Kritéria účasti
Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.
Kritéria způsobilosti
Věk způsobilý ke studiu
18 let a starší (Dospělý, Starší dospělý)
Přijímá zdravé dobrovolníky
Ne
Pohlaví způsobilá ke studiu
Všechno
Popis
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
Studijní plán
Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.
Jak je studie koncipována?
Detaily designu
- Primární účel: Léčba
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Žádné (otevřený štítek)
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
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Experimentální: 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)
Ostatní jména:
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Experimentální: 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)
Ostatní jména:
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Experimentální: 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)
Ostatní jména:
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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Limb Volume (ml)
Časové okno: 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)
Časové okno: 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
Časové okno: 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
Časové okno: 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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Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Cellular Fluid Changes (Ohms)
Časové okno: 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)
Časové okno: 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
Časové okno: 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
Časové okno: 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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Další výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Change in Skin Thickness
Časové okno: 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)
Časové okno: 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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Spolupracovníci a vyšetřovatelé
Zde najdete lidi a organizace zapojené do této studie.
Sponzor
Vyšetřovatelé
- Vrchní vyšetřovatel: Vaughan Keeley, PhD, FRCP, Royal Derby Hospital
Termíny studijních záznamů
Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.
Hlavní termíny studia
Začátek studia (Aktuální)
11. listopadu 2013
Primární dokončení (Aktuální)
31. března 2019
Dokončení studie (Aktuální)
30. června 2019
Termíny zápisu do studia
První předloženo
7. ledna 2014
První předloženo, které splnilo kritéria kontroly kvality
7. ledna 2014
První zveřejněno (Odhad)
9. ledna 2014
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
20. července 2021
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
29. června 2021
Naposledy ověřeno
1. června 2021
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
Další identifikační čísla studie
- 4010 FlexDose
Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .