Trial Summary
What is the purpose of this trial?Lymphedema is a painful and disfiguring condition related to the buildup of protein-rich fluid in the body's tissues. The goal of this research study is to determine the safety and efficacy of a novel, proprietary device in the treatment of upper extremity lymphedema. This device has been previously studied on healthy people that do not have a diagnosis of lymphedema. It was found that using the device on them does not cause significant changes to their vital signs or level of pain. Side effects are reported sometimes; however, these are to be expected and are also frequently reported when people receive the standard of care for their lymphedema. Patients who have diagnosed lymphedema will be approached to participate in this study as part of their care. Participants will wear this device for approximately 40 minutes and then have certain measurements taken before and after doing so. These measurements include the size of their arm, how much pain/discomfort they are currently in, and if they experienced any side effects. After getting treatment with the device, they will receive the standard of care treatment for their lymphedema from their provider. After the standard of care has concluded, the previously mentioned measurements will be repeated. This data will be put together and analyzed to look for differences in arm size before and after treatment with the device as well as to look for the prevalence of side effects.
Will I have to stop taking my current medications?
The trial protocol does not specify whether you need to stop taking your current medications. It seems focused on using a device alongside your regular lymphedema treatment.
What data supports the effectiveness of the treatment LymphaVibe for upper extremity lymphedema?
Research on similar treatments, like compression therapy combined with exercises or devices, shows positive results in reducing arm lymphedema. Additionally, studies on other treatments, such as the use of oak wood extract for leg lymphedema, have shown significant reductions in swelling, suggesting that similar approaches might be effective for upper extremity lymphedema.
12345Eligibility Criteria
This trial is for individuals with upper extremity lymphedema. Participants will be those already diagnosed and receiving care for their condition, willing to use the LymphaVibe device as part of their treatment.Inclusion Criteria
I am 18 years old or older.
I can make my own medical decisions.
I have been diagnosed with lymphedema.
+1 more
Exclusion Criteria
I have had a deep vein thrombosis or pulmonary embolism in the past.
I currently have inflammation in my veins.
I currently have an infection.
+5 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Treatment
Participants receive treatment with the LymphaVibe device and standard decongestive therapy for lymphedema
4 weeks
Weekly visits (in-person)
Follow-up
Participants are monitored for safety and effectiveness after treatment
4 weeks
Weekly visits (in-person)
Participant Groups
The study tests the safety and effectiveness of the LymphaVibe device in treating arm lymphedema. Patients will use the device once, followed by standard care, while measurements are taken before and after to assess changes in arm size and pain.
1Treatment groups
Experimental Treatment
Group I: LymphaVibe Experimental ArmExperimental Treatment1 Intervention
All patients in this single arm (only arm of the study) will receive both treatment with the LymphaVibe AND the standard of care, thus serving as their own control. Patients will have baseline measurements taken, receive treatment with the LymphaVibe, have their measurements repeated, receive the standard of care, and have their measurements repeated again.
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Carilion ClinicRoanoke, VA
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Who Is Running the Clinical Trial?
Carilion ClinicLead Sponsor
Virginia Polytechnic Institute and State UniversityCollaborator
References
Interest of an auto-adjustable nighttime compression sleeve (MOBIDERM® Autofit) in maintenance phase of upper limb lymphedema: the MARILYN pilot RCT. [2022]Breast cancer-related lymphedema (BCRL) is a debilitating condition. The recommended treatment is based on decongestive lymphedema therapy (DLT) with two separate phases: a short-term intensive phase to reduce lymphedema volume and a long-term maintenance phase to stabilize it. Optimizing compression therapy and compliance during maintenance phase are key factors for long-term control of lymphedema. The primary objective of this pilot prospective open-label randomized study was to assess the benefit of a new auto-adjustable nighttime arm sleeve (MOBIDERM® Autofit) on lymphedema volume during the maintenance phase after the intensive phase.
French Oak Wood (Quercus robur) Extract (Robuvit) in Primary Lymphedema: A Supplement, Pilot, Registry Evaluation. [2020]The aim of this pilot supplement study was the evaluation of an oak wood extract (Robuvit, Quercus robur [QR], Horphag Research) in an 8-week registry study on lymphatic signs in primary lymphedema. Subjects with primary lymphedema confined to a single leg without skin changes or ulcerations were followed for at least 8 weeks. Lymphedema was mainly present distally (below the knee). Three groups were formed: one group used only the standard management for lymphedema; one used the same management plus 300 mg Robuvit; and one used the standard management plus 600 mg of Robuvit. The three groups were comparable. After 8 weeks the variation in leg volume was on average -6.2% with standard management, -15% in the QR 300 mg group, and -18.9% in the 600 mg group. The edema score was also significantly lower at 8 weeks in the two QR groups. The variation in proteins in the interstitial fluid in comparison with initial values was -14.8% in controls in comparison with -29.9% in QR 300 mg group and -36.9% in QR 600 mg group. Skin flux significantly improved (increased) in the two QR groups. Ultrasound pretibial skin thickness was decreased on average 6% in controls versus 10.3% in the low-dose QR group and 11.8% in the higher dose group. Perimalleolar thickness was decreased 7% in controls and more in the two QR groups. Ankle circumference was decreased 4.4% in controls and more in the two supplement groups. This pilot registry indicates that Robuvit can be effective in the management of primary lymphedema. More patients and longer evaluation periods are needed.
Synergic effect of compression therapy and controlled active exercises using a facilitating device in the treatment of arm lymphedema. [2021]A randomized controlled trial was performed to evaluate the effect of the combination of compression therapy with active exercising using a facilitating apparatus on arm lymphedema.
Aquatic Exercise Training Outcomes on Functional Capacity, Quality of Life, and Lower Limb Lymphedema: Pilot Study. [2018]To investigate whether patients with lower limb lymphedema (LLL) can benefit from water immersion exercise training to improve functional capacity, quality of life (QOL), and help control/diminish limb volume.
Follow-up study of upper limb lymphedema patients treated by microsurgical lymphaticovenous implantation (MLVI) combined with compression therapy. [2007]We present a follow-up study of 18 patients with upper limb lymphedema treated by microsurgical lymphaticovenous implantation (MLVI) combined with compression therapy. This combined technique provides increased lymphatic flow through newly created lymphaticovenous bypasses by the MLVI surgery, with assistance for pumping function in the lymphatics by compression therapy. Preoperative assessment of the affected limb was performed by the average enlargement of edema circumference (AEEC), comparing the lymphedema limb and normal limb circumferences. Objective improvement was analyzed by the percent reduction of edema circumference (%REC) at two levels of the lymphedema limb. With an average follow-up of 24 months, 77.8% of patients presented excellent or good results, with %REC >50% at either the distal or proximal site of the treated limb. This combined treatment can be expected to provide favorable long-term results, even for patients with AEEC >8 cm.