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CVR Registry Evaluating Flexitouch Plus and Conservative Care vs Conservative Care Only for Treatment of Lymphedema

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ClinicalTrials.gov Identifier: NCT04116099
Recruitment Status : Recruiting
First Posted : October 4, 2019
Last Update Posted : March 30, 2021
Sponsor:
Information provided by (Responsible Party):
Tactile Medical

Brief Summary:
Subjects with lower extremity lymphedema will be prescribed, per standard of care, to either Flexitouch Plus with conservative care or conservative care only and be followed for 12 months.

Condition or disease Intervention/treatment
Lymphedema Other: Conservative care Device: Flexitouch Plus

Detailed Description:
Conservative care treatment for lymphedema may include use of compression, manual lymphatic drainage (MLD, performed either by a therapist or self-MLD), exercises and skin care. Subjects presenting to a vein clinic (Center for Vein Restoration or CVR) with lymphedema of the lower extremity/ies may receive a standard-of-care prescription for conservative care or for the Flexitouch Plus pneumatic compression device along with conservative care. Subjects will be followed (by phone and in clinic) for 12 months after initiating treatment for venous- and lymphedema-related complications, unscheduled visits, changes in quality of life measures and edema measures, skin changes, and changes to wounds (if present).

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 300 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 12 Months
Official Title: An Observational Registry Evaluating the Flexitouch® Plus in Vascular Clinic Patients With Lower Extremity Lymphedema
Actual Study Start Date : October 10, 2019
Estimated Primary Completion Date : April 2022
Estimated Study Completion Date : April 2022


Group/Cohort Intervention/treatment
Conservative care alone
Conservative care alone which may include graduated compression, manual lymphatic drainage (MLD) performed by a licensed therapist, self-MLD, and instruction on exercise and skin care.
Other: Conservative care
May include graduated compression, MLD performed by a licensed therapist, self-MLD, and instruction on exercise and skin care.

Flexitouch Plus and conservative care
Flexitouch Plus and conservative care which includes Flexitouch Plus treatment as well as conservative care measures which may include graduated compression, manual lymphatic drainage (MLD) performed by a licensed therapist, self-MLD, and instruction on exercise and skin care.
Other: Conservative care
May include graduated compression, MLD performed by a licensed therapist, self-MLD, and instruction on exercise and skin care.

Device: Flexitouch Plus
Flexitouch Plus treatment.




Primary Outcome Measures :
  1. Complications [ Time Frame: 12 months ]
    To evaluate the Flexitouch Plus and conservative care, compared to conservative care alone, in vascular patients with lower extremity lymphedema after 12 months of treatment based upon the number of lymphedema and venous-related complications.

  2. Number of unscheduled visits [ Time Frame: 12 months ]
    To evaluate the Flexitouch Plus and conservative care, compared to conservative care alone, in vascular patients with lower extremity lymphedema after 12 months of treatment based upon the number of lymphedema and venous-related unscheduled follow-up visits (non-routine clinic, hospital, urgent care, and emergency room visits).


Secondary Outcome Measures :
  1. Quality of life changes: Short-Form 12 (SF-12) [ Time Frame: 6 months ]
    To evaluate the effectiveness of the Flexitouch Plus and conservative care, compared to conservative care alone, in vascular patients with lower extremity lymphedema after 6 months of treatment based upon changes in the SF-12. This survey includes 12 questions to measure physical and mental health from the patient's point of view. The questionnaire includes eight health domains: physical functioning, physical health problems, bodily pain, general health, vitality, social functioning, emotional health problems, and mental health. The scoring mechanism uses T scores for all surveys using means and standard deviations from the 1998 US general population. A higher score represents better function.

  2. Quality of life changes: Quality of Life with Venous Insufficiency (CIVIQ-20) [ Time Frame: 6 months ]
    To evaluate the effectiveness of the Flexitouch Plus and conservative care, compared to conservative care alone, in vascular patients with lower extremity lymphedema after 6 months of treatment based upon changes in the CIVIQ-20, which is a survey specific to assess patient-perceived quality of life with chronic venous disorders. The instrument reviews four dimensions - psychological (range 9-45), pain (range 4-20), physical (range 4-20), and social (range 3-15). A global index score can be obtained by adding up the scores of all 20 items (range 20-100). A low score corresponds to greater patient comfort.

  3. Quality of life changes: Lymphedema Quality of Life Tool (LYMQOL) [ Time Frame: 6 months ]
    To evaluate the effectiveness of the Flexitouch Plus and conservative care, compared to conservative care alone, in vascular patients with lower extremity lymphedema after 6 months of treatment based upon changes in the LYMQOL, used to assess lymphedema symptom changes. LYMQOL includes sub-scores for function (range 8-32), appearance (range 7-28), symptoms (range 5-20), and mood (range 6-24) where lower scores represent a better outcome. It also includes an overall QOL sub-score (range 0-10) where a higher score represents a better outcome.

  4. Quality of life changes: Clinical Global Impression of Change - Global Improvement (CGI-I) [ Time Frame: 6 months ]
    To evaluate the effectiveness of the Flexitouch Plus and conservative care, compared to conservative care alone, in vascular patients with lower extremity lymphedema after 6 months of treatment based upon a clinician's response to one question at the 6 month follow-up visit pertaining to overall clinical improvement (range 1-7). A lower score signifies greater improvement.

  5. Quality of life changes: Patient Global Impression of Change (PGIC) [ Time Frame: 6 months ]
    To evaluate the effectiveness of the Flexitouch Plus and conservative care, compared to conservative care alone, in vascular patients with lower extremity lymphedema after 6 months of treatment based upon the patient's response to one question at the 6 month follow-up visit pertaining to overall status change (range 1-7). A lower score signifies greater improvement.

  6. Edema measures [ Time Frame: 6 months ]
    To evaluate the effectiveness of the Flexitouch Plus and conservative care, compared to conservative care alone, in vascular patients with lower extremity lymphedema after 6 months of treatment based upon changes in edema measures on affected/ most affected leg.

  7. Presence and severity of skin changes [ Time Frame: 6 months ]
    To evaluate the effectiveness of the Flexitouch Plus and conservative care, compared to conservative care alone, in vascular patients with lower extremity lymphedema after 6 months of treatment based upon skin changes on affected/ most affected leg.

  8. Wound area [ Time Frame: 6 months ]
    To evaluate the effectiveness of the Flexitouch Plus and conservative care, compared to conservative care alone, in vascular patients with lower extremity lymphedema after 6 months of treatment based upon percent wound area reduction in subjects presenting with wounds.


Other Outcome Measures:
  1. Flexitouch Plus treatment satisfaction [ Time Frame: 6 months ]
    To evaluate Flexitouch Plus treatment satisfaction after 6 months of treatment.

  2. Call volume [ Time Frame: 12 months ]
    Assess subject call volume for conservative care subjects compared to subjects using the Flexitouch Plus and conservative care.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
The study population will be drawn from vascular patients with lower extremity lymphedema that is unilateral or bilateral.
Criteria

Inclusion Criteria:

  1. Male or female 18 years of age or older.
  2. Diagnosis of lower extremity lymphedema (including primary, secondary, chronic venous insufficiency (CVI)-related, unilateral, or bilateral).
  3. Clinical Etiology Anatomy Pathophysiology (CEAP) Classification of C3 or higher.
  4. Willing to comply with prescribed care, protocol requirements, and study-related visits.
  5. Willing and able to provide consent to participate.

Exclusion Criteria:

  1. BMI > 50.
  2. Significant venous reflux disease, as determined by the investigator (e.g., indicated for venous intervention, post intervention with inadequate venous function, or ultrasound evidence of deep venous obstruction).
  3. Unresolved healing at the surgical site following a venous intervention (e.g., ablation, stenting, or venoplasty).
  4. Heart failure (acute pulmonary edema, decompensated acute heart failure).
  5. Acute venous disease (< 6 weeks) such as acute thrombophlebitis, acute deep venous thrombosis, or acute pulmonary embolism.
  6. Significant peripheral artery disease (ankle-brachial index (ABI) < 0.6, critical limb ischemia including ischemic rest pain, arterial wounds or gangrene).
  7. Active skin or limb infection/ inflammatory disease (acute cellulitis, other uncontrolled skin or untreated inflammatory skin disease).
  8. Active cancer (cancer that is currently under treatment, but not yet in remission).
  9. Poorly controlled kidney disease (glomerular filtration rate < 30 mls per minute), hypoproteinemia, pulmonary hypertension, hypothyroidism, cyclic edema, or Munchausen Syndrome.
  10. Any circumstance where increased lymphatic or venous return is undesirable.
  11. Currently pregnant or trying to become pregnant (for Flexitouch Plus and conservative care group).
  12. Current participation in any drug or other device clinical studies.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04116099


Contacts
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Contact: Susy Peters 612-540-7175 speters@tactilemedical.com
Contact: Andrea Stone 612-540-5267 astone@tactilemedical.com

Locations
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United States, Maryland
Center for Vein Restoration - Glen Burnie Recruiting
Glen Burnie, Maryland, United States, 21061
Contact: Kanika Sharma    240-965-3200      
Principal Investigator: Khanh Nguyen, DO         
Center for Vein Restoration - Greenbelt Recruiting
Greenbelt, Maryland, United States, 20770
Contact: Kanika Sharma    240-965-3200      
Sub-Investigator: Vinay Satwah, DO         
Center for Vein Restoration - Silver Spring Recruiting
Silver Spring, Maryland, United States, 20903
Contact: Kanika Sharma    240-965-3200      
Sub-Investigator: Eddie Fernandez, MD         
Sponsors and Collaborators
Tactile Medical
Investigators
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Principal Investigator: Peter Pappas Center for Vein Restoration
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Responsible Party: Tactile Medical
ClinicalTrials.gov Identifier: NCT04116099    
Other Study ID Numbers: 5020
First Posted: October 4, 2019    Key Record Dates
Last Update Posted: March 30, 2021
Last Verified: March 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: Yes
Keywords provided by Tactile Medical:
Lymphedema of Leg
Chronic Venous Insufficiency
Primary Lymphedema
Secondary Lymphedema
Additional relevant MeSH terms:
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Lymphedema
Lymphatic Diseases