Treatment Response to Different Lymphoedema Compression Programs Using a Pneumatic Compression Device

NCT02031627 | Completed Results

• 1 other identifier: 4010 FlexDose
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

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.

Conditions

Lower Extremity Lymphoedema; Leg Lymphoedema

Keywords

lymphedema; lymphoedema; leg lymphoedema; lower extremity lymphoedema; pneumatic compression device

Outcome Measures

Primary Outcomes (4)

• 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

  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)

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

• Cellular Fluid Changes (% Change)

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

• Incidence of Complications

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

• Activity Level

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

Other Outcomes (2)

• Change in Skin Thickness

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

• Change in Local Tissue Water (LTW)

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

Study Arms (3)

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

Interventions

pneumatic compression - 1 hour per day DEVICE

Pneumatic compression treatment once per day (1 hour)

Also known as: Flexitouch pump, Flexitouch device

pneumatic compression - 1 hour per day

pneumatic compression - 2 hours per day DEVICE

pneumatic compression treatment twice per day in the AM \& PM (2 hours)

Also known as: Flexitouch pump, Flexitouch device

pneumatic compression - 2 hours per day

pneumatic compression - 4 hours per day DEVICE

pneumatic compression treatment twice per day consisting of 2 consecutive 1 hour treatments in the AM \& PM (4 hours)

Also known as: Flexitouch pump, Flexitouch device

pneumatic compression - 4 hours per day

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Tactile Medical: lead

Study Sites (1)

Royal Derby Hospital

Derby, DE22 3NE, United Kingdom

Location

MeSH Terms

Conditions

Lymphedema

Condition Hierarchy (Ancestors)

Lymphatic Diseases; Hemic and Lymphatic Diseases

Results Point of Contact

• Title: Susy Peters, Clinical Trial Manager
• Organization: Tactile Medical

speters@tactilemedical.com

612-540-7175

Study Officials

• Vaughan Keeley, PhD, FRCP

  Royal Derby Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 7, 2014
• First Posted: January 9, 2014
• Study Start: November 11, 2013
• Primary Completion: March 31, 2019
• Study Completion: June 30, 2019
• Last Updated: July 20, 2021
• Results First Posted: July 20, 2021

Record last verified: 2021-06

Locations

GB (1)