Lymphedema

This research aims to evaluate the Dayspring Active Wearable Compression Technology in improving lymph flow and to assess its safety and effectiveness in patients who have undergone lymphatic surgery for breast cancer-related lymphedema (BCRL). The study focuses on adults diagnosed with upper extremity edema after lymphatic surgery and investigates how this device may help manage symptoms associated with BCRL. Participants will use the Dayspring Active Wearable Compression System, a device designed to enhance lymph movement following lymphatic surgery. The study is open-label and non-randomized, involving patients with breast cancer-related lymphedema who meet specific volume difference criteria between limbs. The intervention period includes baseline assessments and follow-up evaluations at 28 days. During the study, participants will undergo ICG Fluorescence Lymphatic Imaging both at the start and on day 28 to measure lymphatic function. Researchers will monitor safety and effectiveness through these imaging assessments and track participant adherence to device use. The total participation duration includes initial and follow-up visits within the 28-day study period.

Researchers are evaluating the safety and effectiveness of RLY-2608, a mutant-selective PI3Kα inhibitor, in adults and children with PIK3CA Related Overgrowth Spectrum (PROS) and malformations caused by PIK3CA mutations. This Phase 2 study has three parts: a dose selection phase, an exploratory phase with various participant groups, and a randomized, double-blind study comparing RLY-2608 to placebo. The study includes multiple subpopulations to understand how the drug works across ages and conditions related to PIK3CA mutations. Participants receive oral doses of RLY-2608 tailored for their age group. Children aged 2 to under 12 undergo dose escalation to find the appropriate dose, while those 12 years and older receive fixed doses. The study has single-arm dose expansion cohorts for different age groups, followed by a randomized phase where participants aged 6 and older receive either RLY-2608 or placebo. Dosing schedules and group assignments are carefully designed to assess safety and response in various participant groups. Throughout the study, participants undergo regular assessments including lesion volume measurements, safety labs, ECGs, and evaluations of side effects. Researchers collect samples to confirm PIK3CA mutation status and monitor plasma drug levels. Patient-reported outcomes and quality of life questionnaires are also used. The main outcomes include identifying the recommended dose, tracking adverse events, and measuring changes in lesion size and symptoms over time. Participation continues with regular monitoring until study completion or discontinuation, which may last several months or longer.

Researchers are evaluating the safety and effectiveness of the Symani Surgical System in microsurgical anastomosis during free tissue transfer surgery and lymphovenous anastomosis surgery. This observational study aims to assess the device's performance in real-world settings, focusing on the rate of successful vessel connection in the first surgical attempt and the absence of device-related adverse events. Participants will receive standard surgical care using the Symani Surgical System, which offers articulated, interchangeable instruments designed for open microsurgery procedures. The study includes patients undergoing free tissue transfer of the breast or extremities and those having lymphovenous anastomosis surgery for lymphedema. During the trial, participants will have their surgical procedures assessed and may complete questionnaires if undergoing lymphedema procedures. Throughout the study, researchers will monitor the safety and effectiveness of the device by evaluating intraoperative vessel patency and tracking any adverse events up to 30 days after surgery. Participants will be asked to allow access to their medical information, attend follow-up visits, and complete all study procedures and questionnaires. The total participation covers the surgery period and a 30-day post-surgery follow-up to ensure comprehensive safety and outcome monitoring.

Researchers are conducting a natural history study to better understand lymphatic anomalies, which are disorders affecting the network of vessels that carry lymph fluid through the body. These anomalies can cause pain, fluid buildup, and immune problems. The study aims to improve knowledge about why these conditions develop and to support future treatment advances by collecting detailed data over time from many participants. The study includes people of all ages with suspected or confirmed lymphatic anomalies, as well as their unaffected parents or siblings aged 7 years or older. Participants may have evaluations every 10 months to 2 years and can be seen either via telemedicine or in person at the NIH Clinical Center for 2 to 5 days. During visits, physical exams and various specimen collections like blood, saliva, hair, stool, skin, and other tissues will be done. Some participants will also have heart tests, lung function tests, photographs, imaging scans including bone density measurements, and special scans that track lymph fluid movement under anesthesia. Participants will be closely monitored with physical exams and various tests depending on their condition. The study collects genetic and clinical data to understand disease progression, clinical features, and outcomes. The research team tracks the number and types of lymphatic anomalies, the age when symptoms appear, and any malignant changes. Participants may stay in the study indefinitely to provide long-term data, supporting improved diagnosis, monitoring, and treatment guidelines for lymphatic anomalies.

This research aims to explore the role of indocyanine green-fluorescence imaging in diagnosing and treating cystic lymphatic malformation (cLM) in children. The study will compare this imaging approach with traditional surgical methods to provide clearer scientific evidence for future treatments and better understand the disease's development. Participants are divided into groups receiving different treatments, including inflow occlusion assisted by indocyanine green-fluorescence imaging combined with perforation of septation and sclerotherapy, perforation of septation and sclerotherapy alone, indocyanine green-guided partial resection and sclerotherapy, or partial resection and sclerotherapy. Those in the imaging groups receive special guidance during surgery using the indocyanine green method, while control groups receive traditional methods. During the study, researchers will evaluate cure rates and treatment effectiveness at one and three months after treatment, along with how often treatments are needed over six months. Secondary outcomes include wound infection, delayed healing, pigmentation, and patient scores six months post-treatment. Participants will be followed for three to six months to monitor results and side effects.

Researchers are gathering detailed real-world information on people with chronic wounds and ulcers to better understand their medical journey and treatment outcomes. This observational registry collects data from over 1,400 healthcare providers across the USA and Puerto Rico using a specialized electronic health record system. It includes all major wound types such as diabetic foot ulcers, venous leg ulcers, pressure ulcers, arterial ulcers, surgical wounds, traumatic wounds, and inflammatory ulcers. Participants receive care as usual from their clinicians, who use standard and advanced wound treatments like specialized dressings, compression therapy, offloading devices, cellular and tissue-based products, negative pressure therapy, ultrasound therapy, topical oxygen, hyperbaric oxygen, growth factors, debridement, and topical antibiotics. Data on treatment practices, wound characteristics, patient health conditions, and complications are collected continuously during routine care. Patients may be followed for over five years to track long-term outcomes. During the study, researchers collect information on patient demographics, wound details, treatment methods, visit frequency, and complications. They monitor healing progress, amputations, deaths, wound recurrence, hospitalizations, and other outcomes. The registry uses a wound healing index to adjust for risk and supports quality improvement and research by linking clinical data with insurance claims for comprehensive analysis. This ongoing effort helps to better understand wound healing and treatment effectiveness in everyday healthcare settings.

Researchers are studying the long-term quality of life outcomes in patients with lymphedema who either choose to have surgery using vascularized lymph node transfer (VLNT) or opt for non-surgical management. The study aims to compare these two groups to better understand the impact of surgical versus non-surgical treatment on patient well-being. This observational study is sponsored by Memorial Sloan Kettering Cancer Center and focuses on adults with primary or secondary lymphedema affecting the upper or lower limbs. Participants are divided into two groups based on their treatment choice: those who undergo VLNT surgery and those who receive non-surgical care. There is no additional treatment or intervention during the study follow-up period; the research simply observes and assesses quality of life over time. The study uses established questionnaires such as the Upper Limb Lymphedema (ULL-27), Lymphedema Life Impact Scale version 2 (LLISv2), and LYMQOL-Leg to evaluate patient outcomes. During the study, participants complete quality of life assessments up to 40 months after enrollment. There are no therapeutic procedures administered as part of the study itself. The research team monitors patient responses to these questionnaires to measure the impact of different treatment choices on daily living and overall health. The study includes adults between 18 and 80 years old who speak English and meet specific lymphedema stage criteria.

Researchers are evaluating whether a thorough prevention program can help drain lymph fluid from the arm and prevent lymphedema in women diagnosed with breast cancer who undergo axillary lymph node dissection. The study, sponsored by Memorial Sloan Kettering Cancer Center, is a phase 3 prospective cohort study focusing on reducing lymphedema and improving quality of life after treatment for breast cancer. The program includes immediate lymphatic reconstruction performed during axillary lymph node dissection, followed by self-directed lymphatic massage and range of motion exercises starting 24 to 48 hours after surgery. Participants will also use compression garments daily for at least 8 hours a day for 3 months or until 3 months after completing any additional treatments like chemotherapy or radiation. Arm volume measurements will be taken at each in-person postoperative visit to monitor progress. Participants will be involved in regular follow-up visits for up to 24 months, during which their arm volume will be measured to assess changes from baseline. The study tracks adherence to lymphatic massage, exercises, and compression garment use. Researchers will use these assessments to evaluate the program's effect on reducing arm swelling and improving quality of life after breast cancer surgery.

Researchers are investigating targeted drug therapies for patients with vascular malformations that are resistant to standard treatments or for whom standard treatments are unsuitable. These vascular malformations are classified as either slow-flow or fast-flow types, driven by genetic changes in two specific signalling pathways. This phase II open-label trial aims to evaluate the effects of 48 weeks of treatment using either alpelisib for slow-flow vascular malformations with PI3K pathway mutations or mirdametinib for fast-flow vascular malformations with MAPK pathway mutations. Participants are divided into two treatment groups based on their vascular malformation type and genetic mutation. Those with slow-flow malformations and PI3K pathway mutations will receive alpelisib, an oral PI3-kinase inhibitor, for 48 weeks followed by a 24-week follow-up. Those with fast-flow malformations and MAPK pathway mutations will receive mirdametinib, an investigational oral MEK inhibitor, also for 48 weeks followed by 24 weeks of follow-up. Both treatments are given as monotherapy and involve genetic testing before enrollment to confirm mutations. Throughout the study, participants will undergo various assessments including symptom evaluations using the Vascular Malformation Patient Specific Outcome Measure (VM-PSOM) and OVAMA questionnaires, MRI scans to measure lesion size, and monitoring for adverse events. The primary outcome is the improvement in the most significant symptom after 48 weeks of treatment. Follow-up visits continue for 24 weeks after treatment ends to monitor ongoing effects and safety. The total participation duration for each patient is approximately 72 weeks.

This research is investigating the added value of reconstructive lymphatic surgery in patients with upper or lower limb lymphoedema. The study compares this surgery combined with usual care, called decongestive lymphatic therapy, to usual care alone. The goal is to see if surgery improves lymphoedema-specific quality of life 18 months after treatment. Lymphoedema is a chronic condition causing limb swelling and physical and mental challenges, impacting daily function and work ability. Participants are randomly assigned to one of two groups: one group receives reconstructive lymphatic surgery, which may include lymphovenous anastomosis, lymph node transfer, or both, plus usual care. The other group receives usual care alone, consisting of maintenance decongestive lymphatic therapy including skin care, compression garments, exercises, and manual lymph drainage. Surgery choice is based on each patient's condition following a surgical algorithm. During the study, participants will undergo assessments at various time points up to 36 months. These include quality of life questionnaires, limb volume measurements, physical activity monitoring, work capacity evaluations, and tracking of compression garment use. Researchers will also monitor infections, surgery complications, lymphatic transport, and costs related to lymphoedema. The main outcome is quality of life related to lymphoedema at 18 months. Follow-up continues to evaluate longer-term effects and safety.