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

Lymphedema Clinical Trial

Official title:

An Observational Registry Evaluating the Flexitouch® Plus in Vascular Clinic Patients With Lower Extremity Lymphedema

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04116099
• Other study ID #: 5020
• Status: Terminated
• Start date: October 10, 2019
• Est. completion date: November 24, 2021

Study information

• Verified date: March 2022
• Source: Tactile Medical
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 63
• Est. completion date: November 24, 2021
• Est. primary completion date: November 24, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Lymphedema

Intervention

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.

Locations

Country	Name	City	State
United States	Center for Vein Restoration - Glen Burnie	Glen Burnie	Maryland
United States	Center for Vein Restoration - Greenbelt	Greenbelt	Maryland
United States	Center for Vein Restoration - Silver Spring	Silver Spring	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
Tactile Medical

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Flexitouch Plus treatment satisfaction	To evaluate Flexitouch Plus treatment satisfaction after 6 months of treatment.	6 months
Other	Call volume	Assess subject call volume for conservative care subjects compared to subjects using the Flexitouch Plus and conservative care.	12 months
Primary	Complications	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.	12 months
Primary	Number of unscheduled visits	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).	12 months
Secondary	Quality of life changes: Short-Form 12 (SF-12)	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.	6 months
Secondary	Quality of life changes: Quality of Life with Venous Insufficiency (CIVIQ-20)	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.	6 months
Secondary	Quality of life changes: Lymphedema Quality of Life Tool (LYMQOL)	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.	6 months
Secondary	Quality of life changes: Clinical Global Impression of Change - Global Improvement (CGI-I)	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.	6 months
Secondary	Quality of life changes: Patient Global Impression of Change (PGIC)	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 months
Secondary	Edema measures	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.	6 months
Secondary	Presence and severity of skin changes	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.	6 months
Secondary	Wound area	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.	6 months