N/A
N=21
Treatment Response to Different Lymphoedema Compression Programs Using a Pneumatic Compression Device
Lower Extremity Lymphoedema · Leg Lymphoedema
Bottom Line
View on ClinicalTrials.gov: NCT02031627 ↗Enrolled (actual)
21
Serious AEs
0.0%
Results posted
Jul 2021
Primary outcome: Primary: Limb Volume (ml) — -197; -60; 45 ml
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- pneumatic compression - 1 hour per day (Device); pneumatic compression - 2 hours per day (Device); pneumatic compression - 4 hours per day (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Tactile Medical
- Primary completion
- Mar 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Limb Volume (ml) |
-197; -60; 45 | — |
| PRIMARY Limb Volume (% Change) |
-2.6; -0.7; 0.6 | — |
| PRIMARY Change in Skin Tone |
0.1; 0.5; 0.2; -0.3; -0.7; -1.2 | — |
| PRIMARY Patient Reported Outcomes - MYMOP |
-1.8; -0.7; -0.3; -1.3; 0; -1.5 | — |
| SECONDARY Cellular Fluid Changes (Ohms) |
-5.8; -12.1; -3.8; -12.3; -4.6; 2.1 | — |
| SECONDARY Cellular Fluid Changes (% Change) |
-2.5; -4.5; -1.2; -4.9; -2.0; 1.1 | — |
| SECONDARY Incidence of Complications |
0; 0; 0 | — |
| SECONDARY Activity Level |
28; -1284; 1240 | — |
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.
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
Data sourced from ClinicalTrials.gov (NCT02031627). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.