View clinical trials related to Secondary Lymphedema.
Filter by:The primary aim of this study is to investigate and test whether the use of combined indocyanine green (ICG) lymphography and ultra high frequency ultrasonography can correctly identify lymphatic vessels and venoles in close proximity to each other, for identification prior to lymphovenous anastomosis (LVA) surgery.
A Non-randomized, Open-Label Study to Evaluate the Safety and Effectiveness of Koya Dayspring Active Wearable Compression Technology for Treating Lower Extremity Lymphedema
Lymphedema is the consequence of injured lymphatic system and is characterized by chronic, often disabling swelling of am affected body part, often arm or leg. In the western world secondary lymphedema arises most commonly after removal lymph nodes in an operation as a part of cancer treatment (for example from the armpits or the groin region), however it may also develop as a result of radiation, any other operation, infection or injury that destroys a part of lymphatic system. The disease often develops even years after the event. While there is no cure for lymphedema at present, early detection would ensure timely physiotherapy and application of compression garments that significantly slow down or stop the progression of the disease. However, presently used methods of that are used for diagnosis and evaluating the stage of the disease, are either invasive and expensive or inaccurate and can only be performed at specialized medical centres. Therefore, we developed a simple, affordable and accurate technology, LymphMonitor 1.0 that can allow for testing how efficiently the lymphatic system is functioning. The test can be performed at the local medical centre or potentially even at home. In this study, we investigate whether LymphMonitor 1.0 technology can distinguish between a healthy and a diseased lymphatic system (in lymphedema). This method may allow early diagnosis of lymphedema so that the development of the disease can be detected and prevented early enough. By participating in the study the lymphedema patients are making an important contribution to increasing the quality of life of lymphedema patients. In LymphMonitor 1.0 method method, a solution of a safe fluorescent dye, indocyanine green, is injected painlessly using tiny microneedles, MicronJet600TM, directly into the skin of the arm or leg. After injection, this dye is removed from the skin only through the lymphatic vessels. The intensity of the fluorescence signal corresponds to the amount of dye left in the skin. The decrease in the fluorescence signal after the injection is measured on the surface on the skin using a new device, LymphMeter 1.0. The faster the dye (and that fluorescence signal) disappears from the surface of the skin, the better the lymphatic system works. Therefore in the arm or leg affected by lymphedema the fluorescence signal will decrease much slower compared to the healthy one.
This will be a prospective, randomized controlled study of ~60 adult patients who have undergone a laryngectomy, neck dissection, maxillectomy or mandibulectomy surgical procedure for the treatment of head and neck cancer at Our Lady of the Lake Hospital and have been referred by their physician for evaluation of head and neck lymphedema while serving as an inpatient. Consenting patients will be evaluated by certified speech and language pathologists trained to ascertain lymphedema severity using a series of visual and tangible measurements immediately following surgery and randomized into two cohorts, one receiving the complete decongestive therapy regimen and the other not receiving this specific combination treatment for their edema. Facial and neck measurements will be taken at baseline following surgery and at several points prior to and at discharge as well as at the 2 week follow up visit to the clinic. Measurements and overall change/reduction in edema will be compared between the cohorts.
Persons with secondary arm and/or upper quadrant lymphedema following cancer therapies commonly are prescribed complete decongestive therapy as a course of management of their lymphedema. The investigators will perform a repeated-measures cross-over trial to test the hypothesis that mobilization of protein enriched hardened tissue using graded negative pressure therapy in conjunction with complete decongestive therapy (CDT) is more effective to standard CDT alone for secondary lymphedema management.
This study evaluates the efficacy of Lymfactin® in patients with secondary lymphedema associated with the treatment of breast cancer by comparing the effects of active study treatment Lymfactin® to placebo. The study product will be administered in combination with a surgical lymph node transfer operation. In addition, the safety and tolerability of the Lymfactin® treatment will be evaluated.
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.
A randomised prospective investigation of volume and quality of life results with lymphovenous anastomosis in patients with unilateral arm lymphedema after breast cancer using Indocyanine Green lymphangiography and MD Anderson Staging.
Protocol resume Swelling of tissue due to excess fluid, called lymphedema, is a common side effect of breast cancer treatment that requires lifelong treatment but in what way the treatment of breast cancer affects the lymphatic vasculature is not yet fully understood. The overall aim of this study is to examine the baseline lymphatic function and anatomy in women who have undergone and completed treatment for breast cancer. Comparison will be made between: - The treated arm and the untreated arm in the participant. - The treated arm in patients who did not develop lymphedema and the treated arm in patients who did. By using an emerging technique, Near Infrared fluorescence imaging (NIRF), and non-contrast MRI it is now possible to examine the link between breast cancer treatment and the development of lymphedema. This project will describe the impact of breast cancer treatment on contractile function and morphological changes of the lymphatic vasculature in the upper extremity in patients treated for breast cancer. The study population will consist of 28 patients treated for breast cancer who simultaneously are enrolled in the Skagen 1 trial. The NIRF imaging and MRI will be performed after completion of breast cancer treatment and no later than half a year after completion treatment. All examinations will be made under similar conditions, on the same segment of lymphatic vasculature, in the same room and bed and with patients in the supine position. The estimated duration of each examination is approximately 3,5 hours. Upon arrival participants will receive three injections of ICG distally on each arm, two on the dorsal side and one on the palmar side. Ten minutes after injection, the primary sequence of the lymphatic vessels will be recorded, allowing for calculation of frequency and velocity. Following, the pumping pressure of the lymphatic vessels will be estimated. After completion of the NIRF examination, an MRI scan of the upper body and extremities will be made, allowing for morphological evaluation of the lymphatic system in the region. By studying the lymphatic vessels in these patients, data may elucidate the characteristics of the changes taking place and thus provide new insight for future studies and possibly future treatments and ways to prevent or reduce the development of edema.
Development of lympho-proliferation reticulation quantification using CT.