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 oral PI3K inhibitor, in adults and children with PIK3CA Related Overgrowth Spectrum PROS and malformations driven by PIK3CA mutation. This Phase 2 study has three parts Part 1 focuses on dose selection, Part 2 includes exploratory single-arm cohorts for different participant groups, and Part 3 is a randomized, double-blinded study comparing RLY-2608 to a placebo. Participants receive RLY-2608 orally in various doses depending on their age group and study part. Children aged 2 to under 6 years and 6 to under 12 years undergo dose escalation to find the recommended dose, while older participants receive established doses. Part 3 involves randomization to either RLY-2608 or placebo for participants aged 6 years and older. Each part includes dosing cycles and treatment schedules designed to assess safety and efficacy. During the study, participants undergo assessments including lesion volume measurements, blood tests, ECGs, and biopsies to confirm PIK3CA mutation status. Researchers monitor adverse events and treatment effects through regular visits and imaging at baseline, Week 12, and Week 24. Patient-reported outcomes and quality of life measures are also collected monthly in Part 3. The study spans several years, with ongoing safety and efficacy evaluations throughout treatment and follow-up periods.

Researchers are evaluating the safety and effectiveness of the Symani Surgical System in microsurgical anastomosis during free tissue transfer and lymphovenous anastomosis surgeries. The study focuses on how well the device maintains vessel connection at the first attempt and monitors any device-related adverse events. Participants include adults with clinical indications for these specific microsurgical procedures. The Symani Surgical System, designed for open microsurgery with articulated and interchangeable instruments, is used during surgeries involving vessels between 0.1 and 2.5 mm in diameter. Participants undergo treatment as part of standard care and may be in either free tissue transfer surgery or lymphovenous anastomosis surgery groups. Those in the lymphovenous anastomosis group complete questionnaires and follow prescribed self-care and compression garment use over the study. Participants provide consent for researchers to access their medical information and agree to attend follow-up visits, completing all study procedures and questionnaires. Researchers measure outcomes including device-related adverse events up to 30 days post-procedure and intraoperative vessel patency at first attempt and prior to closure. Additional assessments include procedure times, suturing details, and technical success. The study runs from 2025 to 2027, with ongoing monitoring during the procedure and follow-up visits.

Researchers are conducting a natural history study focused on lymphatic anomalies, which are conditions affecting the network of vessels that carry lymph fluid through the body. These anomalies can cause pain, fluid buildup, and immune system issues. The study aims to better understand why these anomalies develop by collecting detailed data over a long period from many participants, including affected individuals and their unaffected family members. The research will help improve future treatment approaches and establish guidelines for diagnosis and monitoring. Participants include people of all ages with suspected or confirmed lymphatic anomalies, as well as their unaffected parents or siblings aged 7 years or older. The study involves evaluations approximately every 10 months to 2 years, either through telemedicine or at the NIH Clinical Center for stays of 2 to 5 days. During visits, participants undergo physical exams and may provide various biological samples such as blood, saliva, hair follicles, stool, skin, and other tissues for genetic testing. Additional tests may include heart monitoring, lung function tests, photography of physical features, imaging scans including bone density measurement, and specialized lymphatic scans requiring anesthesia and dye injection. Participants involvement includes regular medical assessments, sample collections, and imaging procedures to track disease progression and clinical features over time. The study will gather data to establish a cohort, understand the age and incidence of symptoms, and collect specimens for genetic analysis. Researchers will also explore the malignant potential of anomalies and develop best practices for diagnosis. Participation may continue indefinitely, with ongoing monitoring and evaluations to support long-term understanding of 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 diseases 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 programs effect on reducing arm swelling and improving quality of life after breast cancer surgery.

Researchers are conducting a phase 3, double-blind, randomized, placebo-controlled study to evaluate the effectiveness and safety of KP-001 in patients aged 2 years and older with common venous malformations, common lymphatic malformations, or Klippel-TrenaunayCLOVES syndrome. This adaptive, multicenter trial will take place across sites in North America, Canada, Taiwan, and South Korea and includes oversight by an independent data monitoring committee that may adjust the study based on interim results. Participants will undergo a screening period up to 42 days before treatment begins. During the first 24 weeks, patients will receive either KP-001 oral daily doses 100 mg or lower based on body weight or placebo in a double-blind manner. After 24 weeks, all participants will enter an open-label extension phase where everyone receives KP-001 until 52 weeks. A follow-up visit is scheduled 30 days after the last dose, and patients who discontinue treatment are encouraged to continue study assessments. Throughout the study, vital signs and safety labs including blood counts, chemistry, coagulation tests, and urinalysis will be regularly monitored. Exploratory assessments will examine symptom changes using patient-reported scales such as the Numeric Rating Scale NRS for pain and Patient Global Impression scores. The primary measure is the change in volume of target lesions by MRI at 24 weeks. Secondary outcomes include symptom changes, lesion volume at other time points, clinical event monitoring, and adverse event tracking up to 52 weeks post-dose. Participants will be closely observed for safety and treatment effects during the entire study period.

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.