Varicose Vein

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.

Lipedema is a chronic disorder mainly affecting women, characterized by symmetrical fat buildup in the lower limbs, causing pain, tenderness, swelling, and reduced function. This study investigates how venous insufficiencyproblems with blood flow in leg veinsrelates to symptoms like pain and functional limitations in women with lipedema through a cross-sectional controlled observational design. Participants will undergo venous Doppler ultrasonography to assess venous reflux, vein diameter, and affected vein segments in both superficial and deep venous systems. Clinical examination will determine lipedema stage. Additional assessments include measuring pain severity with a Numeric Rating Scale, evaluating lower limb function with the Lower Extremity Functional Scale, assessing quality of life via the SF-12 questionnaire, and measuring leg circumference at standardized points. During the study, participants complete clinical assessments and questionnaires to evaluate symptom severity, function, and quality of life. Researchers will analyze vascular findings alongside clinical data to understand venous involvement in lipedema. The primary outcome is the presence of venous reflux on Doppler ultrasonography. The study is expected to improve diagnosis and management of lipedema, with participation lasting through baseline assessments.

This research aims to understand how the venous distension reflex VDR works in adults aged 21 to 35. The study explores whether blocking cyclooxygenase COX with ketorolac tromethamine, an intravenous nonsteroidal anti-inflammatory drug NSAID, reduces muscle sympathetic nerve activity during limb venous distension. It also investigates if COX blockade changes vein sizes measured by MRI during venous distension. Participants will undergo a wrist-to-elbow occlusion procedure with infusions of ketorolac tromethamine or saline on separate days, serving as their own control. The ketorolac infusion occurs in two steps a first infusion to block COX and a second to induce venous distension. In the saline control trial, the same volumes of saline are infused without ketorolac. MRI scans will be performed while lying supine to measure vein size before and during occlusion. During the 3-4 hour study visits, continuous recordings of muscle sympathetic nerve activity, vein size via MRI, heart rate, blood pressure, laser-Doppler flowmetry, strain gauge, and impedance will be collected. The trial includes randomized, triple-blinded crossover design, and participants will be monitored closely during procedures to assess the effects of COX blockade and venous distension.

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 devices 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 AMSingle and AMDouble, 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 AMSingle a single layer human amniotic membrane allograft or AMDouble 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 modes of Transcutaneous Electrical Nerve Stimulation TENS Conventional TENS, Low Frequency LF TENS, and High Frequency HF TENS in patients who have undergone total knee arthroplasty. It investigates whether the electrical resistance of swollen edematous tissue affects the TENS amplitude settings. Participants are evaluated both before surgery and in comparison with their opposite knee to understand how edema may influence the adjustment of TENS amplitude. Participants will receive assessments of TENS amplitude settings for all three modes, documenting levels at which tingling is felt, current is clearly noted, and the maximum tolerated amplitude or muscle contraction occurs. Measurements are taken preoperatively and 2 to 3 days after surgery. The study also considers the effects of edema amount and anesthesia type on these amplitude settings. During the study, participants will be evaluated before and shortly after surgery, with assessments focusing on TENS amplitude settings and edema impact. The main outcomes measured include differences in TENS amplitudes for each mode between pre- and post-arthroplasty states. Secondary measures examine how edema and anesthesia type influence amplitudes. The study is observational and continues until December 2026, with participant involvement primarily around the surgery 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.