Back to resultsTreatment Response to Different Lymphoedema Compression Programs Using a Pneumatic Compression Device
Primary Purpose
Lower Extremity Lymphoedema, Leg Lymphoedema
Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
pneumatic compression - 1 hour per day
pneumatic compression - 2 hours per day
pneumatic compression - 4 hours per day
Sponsored by
About this trial
This is an interventional treatment trial for Lower Extremity Lymphoedema focused on measuring lymphedema, lymphoedema, leg lymphoedema, lower extremity lymphoedema, pneumatic compression device
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
Sites / Locations
- Royal Derby Hospital
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Experimental
Arm Label
pneumatic compression - 1 hour per day
pneumatic compression - 2 hours per day
pneumatic compression - 4 hours per day
Arm Description
Pneumatic compression device - 12 consecutive days undergoing a 1 hour treatment regimen.
Pneumatic compression device - 5 consecutive days undergoing 1 hour treatment in the am and 1 hour of treatment in the pm.
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)
Outcomes
Primary Outcome Measures
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.
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 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.
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 Outcome Measures
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.
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.
Incidence of Complications
Number of complications experienced. Incidence based on clinician assessment.
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02031627
Brief Title
Treatment Response to Different Lymphoedema Compression Programs Using a Pneumatic Compression Device
Official Title
Physiologic Response to Varying Lymphoedema Compression Programs With the Flexitouch System
Study Type
Interventional
2. Study Status
Record Verification Date
June 2021
Overall Recruitment Status
Completed
Study Start Date
November 11, 2013 (Actual)
Primary Completion Date
March 31, 2019 (Actual)
Study Completion Date
June 30, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Tactile Medical
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
Detailed Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lower Extremity Lymphoedema, Leg Lymphoedema
Keywords
lymphedema, lymphoedema, leg lymphoedema, lower extremity lymphoedema, pneumatic compression device
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
21 (Actual)
8. Arms, Groups, and Interventions
Arm Title
pneumatic compression - 1 hour per day
Arm Type
Experimental
Arm Description
Pneumatic compression device - 12 consecutive days undergoing a 1 hour treatment regimen.
Arm Title
pneumatic compression - 2 hours per day
Arm Type
Experimental
Arm Description
Pneumatic compression device - 5 consecutive days undergoing 1 hour treatment in the am and 1 hour of treatment in the pm.
Arm Title
pneumatic compression - 4 hours per day
Arm Type
Experimental
Arm Description
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)
Intervention Type
Device
Intervention Name(s)
pneumatic compression - 1 hour per day
Other Intervention Name(s)
Flexitouch pump, Flexitouch device
Intervention Description
Pneumatic compression treatment once per day (1 hour)
Intervention Type
Device
Intervention Name(s)
pneumatic compression - 2 hours per day
Other Intervention Name(s)
Flexitouch pump, Flexitouch device
Intervention Description
pneumatic compression treatment twice per day in the AM & PM (2 hours)
Intervention Type
Device
Intervention Name(s)
pneumatic compression - 4 hours per day
Other Intervention Name(s)
Flexitouch pump, Flexitouch device
Intervention Description
pneumatic compression treatment twice per day consisting of 2 consecutive 1 hour treatments in the AM & PM (4 hours)
Primary Outcome Measure Information:
Title
Limb Volume (ml)
Description
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.
Time Frame
Change baseline to final day (day 12 for Group A and day 5 for Groups B and C)
Title
Limb Volume (% Change)
Description
Limb volume changes measured via perometry reported in percent reduction. A negative value is associated with the clinically-desirable decrease in fluid.
Time Frame
Change baseline to final day (day 12 for Group A and day 5 for Groups B and C)
Title
Change in Skin Tone
Description
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.
Time Frame
Change baseline to final day (day 12 for Group A and day 5 for Groups B and C)
Title
Patient Reported Outcomes - MYMOP
Description
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
Time Frame
Change baseline to final day (day 12 for Group A and day 5 for Groups B and C)
Secondary Outcome Measure Information:
Title
Cellular Fluid Changes (Ohms)
Description
Changes in extra cellular fluid (ECF) on treated leg measured by bioimpedance. A negative number is indicative of a clinically desirable reduction in ECF.
Time Frame
Change after initial treatment on day 1 and change baseline to end of day 5 for all groups
Title
Cellular Fluid Changes (% Change)
Description
Changes in extra cellular fluid (ECF) on treated leg measured by bioimpedance. A negative number is indicative of a clinically desirable reduction in ECF.
Time Frame
Change after initial treatment on day 1 and change baseline to end of day 5 for all groups
Title
Incidence of Complications
Description
Number of complications experienced. Incidence based on clinician assessment.
Time Frame
Change baseline to final day (day 12 for Group A and day 5 for Groups B and C)
Title
Activity Level
Description
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.
Time Frame
Day 1 compared to final treatment day (day 12 for Group A and day 5 for Groups B and C)
Other Pre-specified Outcome Measures:
Title
Change in Skin Thickness
Description
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).
Time Frame
Change baseline to final day (day 12 for Group A and day 5 for Groups B and C)
Title
Change in Local Tissue Water (LTW)
Description
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).
Time Frame
Change baseline to final day (day 12 for Group A and day 5 for Groups B and C)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Vaughan Keeley, PhD, FRCP
Organizational Affiliation
Royal Derby Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Royal Derby Hospital
City
Derby
ZIP/Postal Code
DE22 3NE
Country
United Kingdom
12. IPD Sharing Statement
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Treatment Response to Different Lymphoedema Compression Programs Using a Pneumatic Compression Device
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