Lower Extremity LymphoedemaNCT02031627
Treatment Response to Different Lymphoedema Compression Programs Using a Pneumatic Compression Device
A study testing pneumatic compression - 1 hour per day, pneumatic compression - 2 hours per day and pneumatic compression - 4 hours per day in people with Lower Extremity Lymphoedema and Leg Lymphoedema, run by Tactile Medical at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lower Extremity Lymphoedema, Leg Lymphoedema
- What is being tested?
- pneumatic compression - 1 hour per day, pneumatic compression - 2 hours per day and pneumatic compression - 4 hours per day
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 11 Nov 2013to 30 Jun 2019
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 22Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Lower Extremity Lymphoedema, Leg Lymphoedema
- Being tested
- pneumatic compression - 1 hour per day, pneumatic compression - 2 hours per day, pneumatic compression - 4 hours per day
- Keywords
- lymphedema, lymphoedema, leg lymphoedema, lower extremity lymphoedema, pneumatic compression device
- Medical subject headings
- Lymphedema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pneumatic compression - 1 hour per dayDevice
Also called Flexitouch pump, Flexitouch device
Pneumatic compression treatment once per day (1 hour)
pneumatic compression - 2 hours per dayDevice
Also called Flexitouch pump, Flexitouch device
pneumatic compression treatment twice per day in the AM \& PM (2 hours)
pneumatic compression - 4 hours per dayDevice
Also called Flexitouch pump, Flexitouch device
pneumatic compression treatment twice per day consisting of 2 consecutive 1 hour treatments in the AM \& PM (4 hours)
| Study group | Role | What they receive |
|---|---|---|
| pneumatic compression - 1 hour per day | Experimental | Pneumatic compression device - 12 consecutive days undergoing a 1 hour treatment regimen. Receives: 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. Receives: 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) Receives: Device: pneumatic compression - 4 hours per day |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: Change baseline to final day (day 12 for Group A and day 5 for Groups B and C)
Secondary outcomes (4)
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.
Measured: Change after initial treatment on day 1 and change baseline to end of day 5 for all groups
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.
Measured: Change after initial treatment on day 1 and change baseline to end of day 5 for all groups
Incidence of Complications
Number of complications experienced. Incidence based on clinician assessment.
Measured: Change baseline to final day (day 12 for Group A and day 5 for Groups B and C)
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.
Measured: Day 1 compared to final treatment day (day 12 for Group A and day 5 for Groups B and C)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2014 (estimated)
- Study start11 Nov 2013
- Primary completion31 Mar 2019
- Study completion30 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Lower Extremity LymphoedemaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tactile Medical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Vaughan Keeley, PhD, FRCP, Principal investigator, Royal Derby Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02031627
- Sponsor's protocol ID
- 4010 FlexDose
- Status last verified
- Jun 2021
- First submitted
- 7 Jan 2014
- Last updated
- 20 Jul 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Physiologic Response to Varying Lymphoedema Compression Programs With the Flexitouch System
- ClinicalTrials.gov ID
- NCT02031627
- Acronym / sponsor ID
- 4010 FlexDose
- Conditions
- Lower Extremity Lymphoedema, Leg Lymphoedema
- Keywords
- lymphedema, lymphoedema, leg lymphoedema, lower extremity lymphoedema, pneumatic compression device
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Tactile MedicalIndustry (pharma, biotech, devices)
- Study start
- 11 Nov 2013 (actual)
- Primary completion
- 31 Mar 2019 (actual)
- Study completion
- 30 Jun 2019 (actual)
- First posted
- 9 Jan 2014 (estimated)
- Results
- Posted 20 Jul 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| pneumatic compression - 1 hour per day | Experimental | Device: pneumatic compression - 1 hour per dayPneumatic compression device - 12 consecutive days undergoing a 1 hour treatment regimen. |
| pneumatic compression - 2 hours per day | Experimental | Device: pneumatic compression - 2 hours per dayPneumatic compression device - 5 consecutive days undergoing 1 hour treatment in the am and 1 hour of treatment in the pm. |
| pneumatic compression - 4 hours per day | Experimental | Device: pneumatic compression - 4 hours per dayPneumatic 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) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (22 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| pneumatic compression - 1 hour per dayAlso: Flexitouch pump, Flexitouch devicePneumatic compression treatment once per day (1 hour) | Device | pneumatic compression - 1 hour per day |
| pneumatic compression - 2 hours per dayAlso: Flexitouch pump, Flexitouch devicepneumatic compression treatment twice per day in the AM \& PM (2 hours) | Device | pneumatic compression - 2 hours per day |
| pneumatic compression - 4 hours per dayAlso: Flexitouch pump, Flexitouch devicepneumatic compression treatment twice per day consisting of 2 consecutive 1 hour treatments in the AM \& PM (4 hours) | Device | pneumatic compression - 4 hours per day |
Primary outcome
Limb Volume (ml)
Time frame: 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.
Limb Volume (% Change)
Time frame: 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 in Skin Tone
Time frame: 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.
Patient Reported Outcomes - MYMOP
Time frame: 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
4 secondary outcomes
Cellular Fluid Changes (Ohms)
Time frame: Change after initial treatment on day 1 and change baseline to end of day 5 for all groups
Cellular Fluid Changes (% Change)
Time frame: Change after initial treatment on day 1 and change baseline to end of day 5 for all groups
Incidence of Complications
Time frame: Change baseline to final day (day 12 for Group A and day 5 for Groups B and C)
Activity Level
Time frame: Day 1 compared to final treatment day (day 12 for Group A and day 5 for Groups B and C)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Vaughan Keeley, PhD, FRCP principal investigator
Royal Derby Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing pneumatic compression - 1 hour per day, pneumatic compression - 2 hours per day and pneumatic compression - 4 hours per day in people with Lower Extremity Lymphoedema and Leg Lymphoedema, run by Tactile Medical at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 20 Jul 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Limb Volume (ml) (time frame: Change baseline to final day (day 12 for Group A and day 5 for Groups B and C)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jul 2021.