Lipedema Clinical Trial
Official title:
Complete Decongestive Therapy With Negative Pressure for Lipedema and Lymphedema Therapy
Verified date | May 2020 |
Source | Vanderbilt University Medical Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 10 |
Est. completion date | February 28, 2020 |
Est. primary completion date | October 30, 2019 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 14 Years to 90 Years |
Eligibility |
Inclusion Criteria: - Females with a diagnosis of lipedema or a probable diagnosis of lipedema - Females with a diagnosis of secondary limb lymphedema following cancer treatments Exclusion Criteria: - 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). |
Country | Name | City | State |
---|---|---|---|
United States | Vanderbilt University Medical Center | Nashville | Tennessee |
Lead Sponsor | Collaborator |
---|---|
Vanderbilt University Medical Center | Lipedema Foundation |
United States,
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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | Assessing a Change in Lymphatic stasis Following CDT with Graded Negative Pressure | Quantitative analysis of lymphatic stasis using non-invasive MR lymphangiography | At baseline and at 6-8 weeks following the completion of therapy | |
Secondary | Assessing a Change in Limb Volume Following CDT with Graded Negative Pressure | Volume quantified using Perometer | At baseline and at 6-8 weeks following the completion of therapy | |
Secondary | Assessing a Change in Sodium Levels in Regions of Interest Following CDT with Graded Negative Pressure | Quantitative analysis of sodium levels using non-invasive sodium MRI | At baseline and at 6-8 weeks following the completion of therapy |
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