Varicose Vein

Researchers are evaluating the safety, effectiveness, and how the body processes different doses of JMKX003142 tablets in patients with renal edema. This phase 2 study is designed as a randomized, open-label, and active-controlled trial conducted in China. JMKX003142 is a drug that blocks arginine vasopressin V2 receptors and has shown strong diuretic effects in healthy volunteers. Participants will be randomly assigned to one of four groups: a low-dose, median-dose, or high-dose group of JMKX003142 tablets, or an active comparator group receiving torasemide tablets. All treatments are taken orally once daily for 7 days. The study aims to observe the safety, efficacy, and pharmacokinetic characteristics of these treatments. During the study, participants will have their body weight measured after 7 days as the primary outcome. Safety and efficacy will be monitored throughout the treatment period. Participants must be at least 18 years old and diagnosed with renal edema. The study includes regular assessments to ensure participant safety and adherence to treatment, with the trial expected to complete by July 2026.

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 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.

Researchers are studying the venous distension reflex (VDR) in healthy adults aged 21 to 35 years. The study aims to understand how blocking the cyclooxygenase (COX) system with the drug ketorolac tromethamine affects muscle sympathetic nerve activity (MSNA) and vein size during limb venous distension. This research explores whether COX byproducts directly stimulate nerve responses or cause vein dilation that leads to nerve stimulation. Participants undergo a wrist-to-elbow occlusion procedure on one arm, followed by two infusions: first, ketorolac tromethamine to block the COX pathway, then a second infusion to induce venous distension. On a separate day, a control trial with saline infusions is performed. During the procedure, vein size is measured using a 3T MRI scanner while blood pressure and heart rate are recorded. Throughout the 3-4 hour study visit, continuous monitoring includes microneurography (MSNA), MRI vein imaging, heart rate, blood pressure, laser-Doppler flowmetry, strain gauge, and impedance measurements. Participants will be observed during the infusions and occlusion procedures to assess physiological responses. The study helps clarify the mechanisms involved in venous reflexes and circulatory control.

This research aims to validate the Caprini score in adult patients undergoing various types of varicose vein surgeries, including endovascular procedures like endovenous laser treatment (EVLT), radiofrequency ablation (RFA), and ultrasound-guided foam sclerotherapy (USFS). The goal is to identify patients at higher risk of postoperative venous thromboembolism (VTE) who might benefit from preventive anticoagulation. The study is conducted as a prospective cohort based on an ongoing registry of chronic venous disease treatments. Participants will undergo one of several varicose vein surgeries with or without prophylaxis and will be monitored for venous thromboembolic complications. Procedures include EVLT, RFA, ultrasound-guided foam sclerotherapy, high ligation and stripping, miniphlebectomy, and sclerotherapy. Post-procedure, some patients may use graduated compression stockings or receive low-molecular-weight heparin depending on physician decision. Follow-up is planned for 2 to 4 weeks after surgery, including mandatory duplex ultrasound. During the 4-week follow-up, participants will be assessed for symptomatic and asymptomatic deep vein thrombosis, pulmonary embolism, thermal-induced thrombosis after thermal ablations, and bleeding events. Clinical evaluations, ultrasound exams, and other routine observations will be performed to monitor for any VTE episodes and safety outcomes. The primary outcome is any VTE event within 4 weeks, with secondary outcomes including bleeding and mortality. The study is sponsored by Pirogov Russian National Research Medical University.

This research aims to evaluate the effectiveness and health economics of a Novel Portable Non-Pneumatic Active Compression Device (NPCD) called Dayspring for people with lymphedema or phlebolymphedema, conditions related to chronic venous insufficiency affecting the lower limbs. The study is open-label and conducted at multiple centers, focusing on how this device may impact health outcomes and costs. Participants will use the Dayspring device, an FDA-cleared active wearable compression garment that applies controlled, sequential pressure from the lower to upper parts of the limb in cycles. This device is programmable and designed to help manage symptoms by improving blood and lymph flow. The study lasts for six months and includes monitoring the device’s performance and effects on the participants. Throughout the study, participants will be assessed for changes in limb swelling, mobility measured by daily steps, venous clinical severity, and hospital resource use related to adverse events. Safety and any side effects will also be tracked. The total study duration for each participant is six months, with regular evaluations to monitor progress and health status.

Researchers are evaluating the effectiveness of multiple human placental membrane products, called CAMPs, combined with Standard of Care (SOC) versus SOC alone in treating nonhealing diabetic foot ulcers (DFUs) and venous leg ulcers (VLUs). This multicenter, prospective, randomized controlled trial uses a modified platform design to compare different CAMP products, including AM/Single and AM/Double, in promoting ulcer closure over 12 weeks. Participants will receive weekly treatments depending on their assigned group. The Standard of Care involves cleaning, debridement, moisture balance, and offloading or compression as appropriate. Those in CAMP groups will receive weekly applications of either AM/Single (a single layer human amniotic membrane allograft) or AM/Double (a double layer allograft) in addition to Standard of Care. Treatment continues until the ulcer closes or up to 12 weeks. During the study, participants will attend weekly visits for treatment and evaluation. Researchers will assess ulcer closure rates, time to closure, percent area reduction, pain changes, adverse events, and quality of life improvements over 12 weeks. The study monitors participants closely to measure healing progress and safety of the treatments throughout the trial duration.

This research aims to compare the clinical effectiveness of two minimally invasive treatments, ultrasound-guided radiofrequency ablation and microwave ablation, for primary small saphenous varicose veins, a type of chronic venous insufficiency affecting the lower limbs. Small saphenous varicose veins are less common but more challenging to treat due to their anatomical connection to the popliteal vein and the risk of nerve injury with traditional surgery. The study addresses the need for safer, less invasive options with fewer complications and better recovery. Participants will receive either radiofrequency ablation or microwave ablation, both performed under local anesthesia with ultrasound guidance. The procedure involves injecting anesthetic along the vein, making a small incision near the ankle, and inserting a catheter to deliver energy to close the affected vein. Patients will be monitored for postoperative recovery, including length of hospital stay, time to mobilization, pain scores, and complications. Follow-up with Doppler ultrasound will occur at 2 weeks, 1 month, and 3 months to check for vein closure and recurrence. Quality of life and symptom assessments will be conducted using standardized scoring systems. During the study, participants will undergo several evaluations including clinical symptom assessments, venous ultrasound imaging, and questionnaires on venous disease impact and quality of life. The primary outcome is the vein occlusion rate at 6 months after surgery. Researchers will also track complications and the effectiveness of each treatment over time. The total participation period includes these follow-ups and assessments to ensure safety and monitor long-term treatment success.

This research aims to compare the amplitude settings of three different frequency Transcutaneous Electrical Nerve Stimulation (TENS) modes—Conventional TENS, Low Frequency (LF) TENS, and High Frequency (HF) TENS—in patients undergoing total knee arthroplasty. The study investigates whether the electrical resistance of swollen (edematous) tissue affects the adjustment of TENS amplitude. Participants will be evaluated before surgery and compared with their contralateral (opposite) knee to understand these changes. Participants will receive TENS treatments using three different frequency modes. The researchers will record the amplitude levels at which participants feel tingling, clearly sense the current, experience maximum tolerance, or muscle contraction. These amplitude settings will be compared between the preoperative state and the postoperative state 2 to 3 days after surgery, as well as with the opposite knee. The study also considers the impact of the type of anesthesia and the amount of swelling on TENS amplitude settings. During the study, participants will be assessed before and after surgery through various measurements, including TENS amplitude at different sensation levels. The main outcomes measured are the differences in amplitude between pre- and post-surgery for each TENS mode within 2 to 3 days after surgery. Secondary assessments will examine how edema and anesthesia type affect these amplitudes. Safety and eligibility will be carefully monitored, and participants' pain and swelling levels will be observed throughout the study period.

Chronic Venous Disease (CVD) affects many people worldwide and can range from mild symptoms like small visible veins to severe issues such as venous ulcers. Compression therapy is the standard treatment, but many people have trouble sticking with it due to physical discomfort, appearance concerns, and lack of education. This study aims to test an educational program designed to improve adherence to compression therapy, reduce pain, and decrease ulcer size in people with venous ulcers in Hualpen, Chile during 2024. The intervention involves four face-to-face educational sessions that complement the usual care of compressive bandaging for venous ulcers. This program is based on theories of self-care for chronic diseases and focuses on helping patients recognize symptoms and manage their condition better. The study uses a single group design without a control group and will assess changes before and after the educational sessions. Participants will be followed for 12 weeks while researchers measure how well they accept the educational program, their adherence to compression therapy, and the size of their ulcers. Pain intensity, wound exudate, and symptom control will also be monitored. The study seeks to understand if this approach can promote better care and improve quality of life, with recruitment expected to start in late 2024 and involve about 22 adults with grade 2 venous ulcers.