Complete Decongestive Therapy With Negative Pressure for Lipedema and Lymphedema Therapy

NCT03634462 | Completed

• 2 other identifiers: 160199LF Award #12
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

This study is designed to investigate the therapy outcomes from routine physical therapy in persons with lipedema and secondary limb lymphedema. Complete decongestive therapy (CDT) is a common conservative treatment to optimize lymphatic functioning using exercise, compression, lymphatic stimulation and skin care. PhysioTouch is a gentle graded negative pressure device designed to enhance lymphatic stimulation that is used by the skilled therapist in conjunction with hands on techniques of tissue mobilization for enhanced clearance of lymph stasis in persons with lymphedema. This study will investigate the conservative treatment impact in patients with lipedema and lower extremity lymphedema using this conservative available technique.

Conditions

Lipedema; Secondary Lymphedema

Keywords

lipedema; lymphedema; therapy; sodium; swelling

Outcome Measures

Primary Outcomes (1)

• Assessing a Change in Bioimpedance Spectroscopy (BIS) Following CDT with Graded Negative Pressure

  BIS quantified using Impedimed L-dex

  At baseline and at 6-8 weeks following the completion of therapy

Secondary Outcomes (3)

• Assessing a Change in Lymphatic stasis Following CDT with Graded Negative Pressure

  At baseline and at 6-8 weeks following the completion of therapy

• Assessing a Change in Limb Volume Following CDT with Graded Negative Pressure

  At baseline and at 6-8 weeks following the completion of therapy

• Assessing a Change in Sodium Levels in Regions of Interest Following CDT with Graded Negative Pressure

  At baseline and at 6-8 weeks following the completion of therapy

Study Arms (2)

Patients with Lipedema

EXPERIMENTAL

Females with lipedema who meet the inclusion and exclusion criteria for lipedema and this study requirements. The intervention in this arm is a course of CDT with graded negative pressure.

Other: CDT with graded negative pressure

Patients with secondary leg lymphedema

EXPERIMENTAL

Patients with secondary leg lymphedema following cancer therapies will be limited to the female gender since the comparison group of patients have lipedema which is a condition predominantly effecting females. These patient subjects will consist of those who meet the inclusion and exclusion criteria for secondary leg lymphedema and this study requirements. The intervention in this arm is a course of CDT with graded negative pressure.

Other: CDT with graded negative pressure

Interventions

CDT with graded negative pressure OTHER

Complete Decongestive Therapy (CDT)is a common conservative intervention involving stimulation of the lymphatic system, use of compression, skin care and exercise. The use of graded negative pressure in conjunction with CDT is another conservative therapy intervention used to help clear the lymphatic congestion.

Patients with Lipedema; Patients with secondary leg lymphedema

Eligibility Criteria

• Age: 14 Years - 90 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Females with a diagnosis of lipedema or a probable diagnosis of lipedema
• Females with a diagnosis of secondary limb lymphedema following cancer treatments

You may not qualify if:

• Subjects who have any type of non-MRI compatible bioimplant activated by mechanical, electronic, or magnetic means (e.g., cochlear implants, pacemakers, neurostimulators, biostimulators, electronic infusion pumps, etc.) or are not able to comfortably be able to tolerate the limited fit of the MRI
• Subjects who have any type of ferromagnetic bioimplant that could potentially be displaced.
• Subjects who may have shrapnel imbedded in their bodies (such as from war wounds), metal workers and machinists (potential for metallic fragments in or near the eyes).
• Pregnant women will be excluded from the MRI portion of the study only
• Subjects who have open wounds on either ankle or top of foot because of contraindications with placement of electrodes to obtain the L-DEX U400 readings.
• Persons with heart pacemakers.
• Persons with Dercum's disease, diabetes or high blood pressure (systolic great than 140 and diastolic great than 90).

Sponsors & Collaborators

• Vanderbilt University Medical Center: lead
• Lipedema Foundation: collaborator

Study Sites (1)

Vanderbilt University Medical Center

Nashville, Tennessee, 37212, United States

Location

Related Publications (1)

• Crescenzi R, Marton A, Donahue PMC, Mahany HB, Lants SK, Wang P, Beckman JA, Donahue MJ, Titze J. Tissue Sodium Content is Elevated in the Skin and Subcutaneous Adipose Tissue in Women with Lipedema. Obesity (Silver Spring). 2018 Feb;26(2):310-317. doi: 10.1002/oby.22090. Epub 2017 Dec 27.

  PMID: 29280322 BACKGROUND

MeSH Terms

Conditions

Lipedema; Lymphedema

Interventions

carbohydrate-deficient transferrin

Condition Hierarchy (Ancestors)

Connective Tissue Diseases; Skin and Connective Tissue Diseases; Lymphatic Diseases; Hemic and Lymphatic Diseases

Study Officials

• Manus J Donahue, PhD

  Vanderbilt University Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: Subjects with lipedema or secondary leg lymphedema will receive standard manual lymphatic drainage therapy with negative pressure.

Study Record Dates

• First Submitted: August 9, 2018
• First Posted: August 16, 2018
• Study Start: January 15, 2019
• Primary Completion: October 30, 2019
• Study Completion: February 28, 2020
• Last Updated: May 19, 2020

Record last verified: 2020-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)