Treatment Response to Different Lymphoedema Compression P... | NCT02031627

Status Module

Description Module

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
pneumatic compression - 1 hour per day	Experimental	Pneumatic compression device - 12 consecutive days undergoing a 1 hour treatment regimen.	Device: pneumatic compression - 1 hour per day
pneumatic compression - 2 hours per day	Experimental	Pneumatic compression device - 5 consecutive days undergoing 1 hour treatment in the am and 1 hour of treatment in the pm.	Device: pneumatic compression - 2 hours per day
pneumatic compression - 4 hours per day	Experimental	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)	Device: pneumatic compression - 4 hours per day

Name	Type	Description	Arm Group Labels	Other Names
pneumatic compression - 1 hour per day	Device	Pneumatic compression treatment once per day (1 hour)	pneumatic compression - 1 hour per day

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Limb Volume (ml)	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)	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	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	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

Secondary Outcomes

Measure	Description	Time Frame
Cellular Fluid Changes (Ohms)	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)

Other Outcomes

Measure	Description	Time Frame
Change in Skin Thickness	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)

Eligibility Module

Eligibility Criteria

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

Name	Affiliation	Role
Vaughan Keeley, PhD, FRCP	Royal Derby Hospital	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
Royal Derby Hospital		Derby		DE22 3NE	United Kingdom

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Group A	12 consecutive days undergoing a 1-hour pneumatic compression treatment once per day (1 hour total daily)
FG001	Group B	5 consecutive days undergoing a 1-hour pneumatic compression treatment in the AM and 1 hour of treatment in the PM (2 hours total daily)

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot_SAP	Yes	Yes	No	Study Protocol and Statistical Analysis Plan	Mar 13, 2014

Arm/Group Information

ID	Title	Description
BG000	Group A	12 consecutive days undergoing a 1-hour pneumatic compression treatment once per day (1 hour total daily)
BG001	Group B	5 consecutive days undergoing a 1-hour pneumatic compression treatment in the AM and 1 hour of treatment in the PM (2 hours total daily)
BG002	Group C	5 consecutive days undergoing 2 consecutive 1-hour pneumatic compression treatments in the AM and again in the PM (4 hours total daily)
BG003	Total	Total of all reporting groups

Units	Counts
Participants	BG0007 BG0017 BG0027 BG00321

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age, Continuous

Mean

Standard Deviation

years

Title

Denominators

Categories

Title	Measurements
	BG00065.5± 6.7 BG00158.1± 11.1 BG00250.4± 18.3 BG003

Sex: Female, Male

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Female	BG0005 BG0017 BG002

Race (NIH/OMB)

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
American Indian or Alaska Native	BG0000 BG0010 BG002

Region of Enrollment

Number

participants

Title

Denominators

Categories

United Kingdom

Title	Measurements
	BG0007 BG0017 BG002

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Limb Volume (ml)

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.

Posted

Mean

Standard Deviation

Change baseline to final day (day 12 for Group A and day 5 for Groups B and C)

ID	Title	Description
OG000	Group A	12 consecutive days undergoing a 1-hour pneumatic compression treatment once per day (1 hour total daily)
OG001	Group B	5 consecutive days undergoing a 1-hour pneumatic compression treatment in the AM and 1 hour of treatment in the PM (2 hours total daily)
OG002	Group C	5 consecutive days undergoing 2 consecutive 1-hour pneumatic compression treatments in the AM and again in the PM (4 hours total daily)

Units	Counts
Participants	OG0007 OG0017 OG0027

Title

Denominators

Categories

Title	Measurements
	OG000-197± 78 OG001-60± 126 OG00245± 381

Primary

Limb Volume (% Change)

Limb volume changes measured via perometry reported in percent reduction. A negative value is associated with the clinically-desirable decrease in fluid.

Posted

Mean

Standard Deviation

% reduction

Change baseline to final day (day 12 for Group A and day 5 for Groups B and C)

ID	Title	Description
OG000	Group A	12 consecutive days undergoing a 1-hour pneumatic compression treatment once per day (1 hour total daily)
OG001	Group B	5 consecutive days undergoing a 1-hour pneumatic compression treatment in the AM and 1 hour of treatment in the PM (2 hours total daily)
OG002	Group C	5 consecutive days undergoing 2 consecutive 1-hour pneumatic compression treatments in the AM and again in the PM (4 hours total daily)

Units	Counts
Participants

Primary

Change in Skin Tone

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.

Posted

Mean

Standard Deviation

Change baseline to final day (day 12 for Group A and day 5 for Groups B and C)

ID	Title	Description
OG000	Group A	12 consecutive days undergoing a 1-hour pneumatic compression treatment once per day (1 hour total daily)
OG001	Group B	5 consecutive days undergoing a 1-hour pneumatic compression treatment in the AM and 1 hour of treatment in the PM (2 hours total daily)
OG002	Group C	5 consecutive days undergoing 2 consecutive 1-hour pneumatic compression treatments in the AM and again in the PM (4 hours total daily)

Units	Counts

Primary

Patient Reported Outcomes - MYMOP

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

Posted

Mean

Standard Deviation

score on a scale

Change baseline to final day (day 12 for Group A and day 5 for Groups B and C)

ID	Title	Description
OG000	Group A	12 consecutive days undergoing a 1-hour pneumatic compression treatment once per day (1 hour total daily)
OG001	Group B	5 consecutive days undergoing a 1-hour pneumatic compression treatment in the AM and 1 hour of treatment in the PM (2 hours total daily)
OG002

Secondary

Cellular Fluid Changes (Ohms)

Changes in extra cellular fluid (ECF) on treated leg measured by bioimpedance. A negative number is indicative of a clinically desirable reduction in ECF.

Posted

Mean

Standard Deviation

ohms

Change after initial treatment on day 1 and change baseline to end of day 5 for all groups

ID	Title	Description
OG000	Group A	12 consecutive days undergoing a 1-hour pneumatic compression treatment once per day (1 hour total daily)
OG001	Group B	5 consecutive days undergoing a 1-hour pneumatic compression treatment in the AM and 1 hour of treatment in the PM (2 hours total daily)
OG002	Group C	5 consecutive days undergoing 2 consecutive 1-hour pneumatic compression treatments in the AM and again in the PM (4 hours total daily)

Units	Counts
Participants

Secondary

Cellular Fluid Changes (% Change)

Changes in extra cellular fluid (ECF) on treated leg measured by bioimpedance. A negative number is indicative of a clinically desirable reduction in ECF.

Posted

Mean

Standard Deviation

percent fluid change

Change after initial treatment on day 1 and change baseline to end of day 5 for all groups

ID	Title	Description
OG000	Group A	12 consecutive days undergoing a 1-hour pneumatic compression treatment once per day (1 hour total daily)
OG001	Group B	5 consecutive days undergoing a 1-hour pneumatic compression treatment in the AM and 1 hour of treatment in the PM (2 hours total daily)
OG002	Group C	5 consecutive days undergoing 2 consecutive 1-hour pneumatic compression treatments in the AM and again in the PM (4 hours total daily)

Units	Counts
Participants

Secondary

Incidence of Complications

Number of complications experienced. Incidence based on clinician assessment.

Posted

Number

Complications

Change baseline to final day (day 12 for Group A and day 5 for Groups B and C)

ID	Title	Description
OG000	Group A	12 consecutive days undergoing a 1-hour pneumatic compression treatment once per day (1 hour total daily)
OG001	Group B	5 consecutive days undergoing a 1-hour pneumatic compression treatment in the AM and 1 hour of treatment in the PM (2 hours total daily)
OG002	Group C	5 consecutive days undergoing 2 consecutive 1-hour pneumatic compression treatments in the AM and again in the PM (4 hours total daily)

Units	Counts
Participants	OG000

Secondary

Activity Level

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.

Posted

Mean

Standard Deviation

steps

Day 1 compared to final treatment day (day 12 for Group A and day 5 for Groups B and C)

ID	Title	Description
OG000	Group A	12 consecutive days undergoing a 1-hour pneumatic compression treatment once per day (1 hour total daily)
OG001	Group B	5 consecutive days undergoing a 1-hour pneumatic compression treatment in the AM and 1 hour of treatment in the PM (2 hours total daily)
OG002	Group C	5 consecutive days undergoing 2 consecutive 1-hour pneumatic compression treatments in the AM and again in the PM (4 hours total daily)

Units	Counts
Participants

Other Pre-specified

Change in Skin Thickness

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).

Posted

Mean

Standard Deviation

Change baseline to final day (day 12 for Group A and day 5 for Groups B and C)

ID	Title	Description
OG000	Group A	12 consecutive days undergoing a 1-hour pneumatic compression treatment once per day (1 hour total daily)
OG001	Group B	5 consecutive days undergoing a 1-hour pneumatic compression treatment in the AM and 1 hour of treatment in the PM (2 hours total daily)
OG002	Group C	5 consecutive days undergoing 2 consecutive 1-hour pneumatic compression treatments in the AM and again in the PM (4 hours total daily)

Units	Counts
Participants

Other Pre-specified

Change in Local Tissue Water (LTW)

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).

Posted

Mean

Standard Deviation

Change baseline to final day (day 12 for Group A and day 5 for Groups B and C)

ID	Title	Description
OG000	Group A	12 consecutive days undergoing a 1-hour pneumatic compression treatment once per day (1 hour total daily)
OG001	Group B	5 consecutive days undergoing a 1-hour pneumatic compression treatment in the AM and 1 hour of treatment in the PM (2 hours total daily)
OG002	Group C	5 consecutive days undergoing 2 consecutive 1-hour pneumatic compression treatments in the AM and again in the PM (4 hours total daily)

Units	Counts
Participants

Post-Hoc

Patient Reported Outcomes - LYMQOL

Self-reported changes in symptoms in 4 domains: function, appearance, symptoms, and emotion as well as general quality of life (QOL). Measured via LYMQOL (Lymphedema Quality of Life) questionnaire. A decrease in the the domain scores and increase in general QOL indicate a good outcome. Scores range from 1 to 4.

Posted

Mean

Standard Deviation

score on a scale

Change baseline to final day (day 12 for Group A and day 5 for Groups B and C)

ID	Title	Description
OG000	Group A	12 consecutive days undergoing a 1-hour pneumatic compression treatment once per day (1 hour total daily)
OG001	Group B	5 consecutive days undergoing a 1-hour pneumatic compression treatment in the AM and 1 hour of treatment in the PM (2 hours total daily)
OG002	Group C	5 consecutive days undergoing 2 consecutive 1-hour pneumatic compression treatments in the AM and again in the PM (4 hours total daily)

Units	Counts

Arm/Groups

ID	Title	Description	Deaths (At Risk)	Serious Events (At Risk)	Other Events (At Risk)
EG000	Group A	12 consecutive days undergoing a 1-hour pneumatic compression treatment once per day (1 hour total daily)	7	7	7
EG001	Group B	5 consecutive days undergoing a 1-hour pneumatic compression treatment in the AM and 1 hour of treatment in the PM (2 hours total daily)	7	7	7
EG002	Group C	5 consecutive days undergoing 2 consecutive 1-hour pneumatic compression treatments in the AM and again in the PM (4 hours total daily)	7	7	7

ID	Term
D008206	Lymphatic Diseases
D006425	Hemic and Lymphatic Diseases