Venous Insufficiency

Researchers are evaluating the progress of chronic venous leg ulcers in adults using a non-bordered foam dressing. This prospective, open, multi-center, interventional study aims to track wound healing over a 6-week period or until the wound heals. The study focuses on venous leg ulcers that produce moderate to large amounts of fluid and includes 20 participants across centers in the US and Canada. All participants will use the ALLEVYN Non-Adhesive foam dressing as the primary absorbent dressing. This device combines a breathable top film, a highly absorbent foam core, and a non-adhesive wound contact layer designed for comfort and optimal moist wound healing. The dressing will be worn continuously and changed every week during the treatment period. Participants will attend seven visits a baseline visit followed by weekly visits up to six weeks. At each visit, wound progress will be assessed by measuring wound size and evaluating wound condition. Researchers will also monitor pain, comfort, quality of life, dressing performance, and safety throughout the study. The main outcome measured is wound progress from baseline to last follow-up, with additional assessments including wound area reduction, tissue changes, exudate characteristics, skin condition, and adverse events.

Researchers are evaluating the progress of chronic wounds, specifically venous leg ulcers VLU and diabetic foot ulcers DFU, using an absorbent dressing called Mepilex Up. This study is a prospective, open, multi-center, interventional trial designed to observe wound healing over a period of up to six weeks. The goal is to track changes in wound area and condition while participants receive treatment according to local standards of care. Participants will use the Mepilex Up dressing, which is a soft, silicone-based absorbent foam dressing designed to manage wound exudate and protect the skin. The dressing will be applied as the primary dressing and changed weekly for up to six weeks or until the wound heals. The study includes seven visits a baseline visit followed by weekly visits to monitor wound healing and dressing performance. During each visit, researchers will assess wound progress through measurements and evaluations of wound area, volume, tissue quality, exudate, and skin condition. Participants will report on pain, comfort, and quality of life related to wound care. Safety will be monitored at all visits. The total treatment period is a maximum of 44 days or until healing occurs, with detailed tracking of dressing wear time, wound changes, and any adverse events.

The trial investigates the use of EscharEx, a proteolytic enzyme gel, compared to a placebo gel in treating venous leg ulcers VLU in adults. The goal is to evaluate how well EscharEx works and how safe it is for removing dead tissue debridement and preparing the wound bed for healing. This study involves adult patients who have VLUs with specific size and duration criteria. Participants will be randomly assigned to receive either EscharEx EX-03 5% formulation or a placebo gel. The treatment involves applying a gel made by mixing a sterile powder with water to the wound area. The study lasts up to 29 weeks and includes several phases a screening period, up to 8 daily visits for debridement within 2 weeks, weekly wound management visits for up to 12 weeks including wound closure confirmation, and monthly visits over 12 weeks to monitor wound closure durability. During the study, patients will undergo regular clinical assessments of the wound, including visual checks for complete debridement and wound closure, as well as evaluations of healthy tissue growth. The study measures the time taken for complete wound closure and the presence of healthy tissue. Safety and wound healing progress are closely monitored throughout the treatment and follow-up periods, ensuring adherence to the protocol and proper wound management.

Researchers are evaluating the effectiveness of human placental membrane products combined with standard care for treating nonhealing diabetic foot ulcers and venous leg ulcers. This multicenter, prospective, controlled trial follows a rescue design where patients who do not heal with standard care in a related trial may receive one of the study products. Patients must meet specific medical criteria for cellular or matrix-like products as outlined by Medicare guidelines. Participants are randomly assigned to receive one of several human amniotic membrane allograft productsTri-Membrane Wrap, Membrane Wrap, Membrane Wrap-Lite, or Membrane Wrap-Hydroalong with standard care. These products are applied weekly until the ulcer heals or up to a maximum of 12 weeks. The trial includes a rescue phase for those who fail to heal in the standard care arm of a previous related study. During the study, participants attend weekly visits for treatment application and monitoring. Researchers will assess wound closure percentage within 1 to 12 weeks as the primary outcome. Secondary measures include time to wound closure, area reduction, adverse events, quality of life improvements, and pain levels for those with significant pain. The total participation period may last up to 12 weeks, with regular evaluations to track healing and safety.

This research aims to evaluate the effectiveness, safety, and tolerability of DermaBind TL, a full-thickness dehydrated placental allograft, in patients with chronic non-healing ulcers, including diabetic foot ulcers DFUs and venous leg ulcers VLUs. The trial focuses on patients whose wounds have not responded to standard treatments. The study is a prospective, multi-center, open-label, single-arm clinical trial led by HealthTech Wound Care, designed to collect outcome data over a 12-week treatment period. Participants will receive DermaBind TL applied to their wounds while following standard care, including offloading with devices like CAM boots or total contact casting, wound debridement, infection management, and layered dressings for protection. The treatment phase lasts 12 weeks with assessments for wound area protection, infection rates, and adverse events. The study includes a screening phase to determine eligibility before treatment begins. During the study, clinicians will assess wounds regularly to monitor wound size, infection, and healing progress. Data will be collected on the number of grafts used and any treatment-related adverse effects. Outcome measures include wound area preservation and protective effects of the dressing over 13 weeks. Participants must comply with offloading and dressing protocols and will be followed for safety and treatment tolerability throughout the study duration.

Researchers are evaluating non-invasive imaging methods to assess skin blood flow dynamics. This study aims to test and validate how well these imaging technologies perform by using a pressure cuff to create changes in blood flow, ranging from low flow ischemic to high flow hyperemic. The focus is on establishing the basic feasibility of these imaging tools in detecting vascular changes. The study uses Multi-Spectral Imaging and Laser Speckle Imaging, both non-contact optical devices. Multi-Spectral Imaging measures concentrations of total, deoxygenated, and oxygenated hemoglobin in tissue, while Laser Speckle Imaging measures relative blood flow at different times. A pressure cuff occlusion is applied to stimulate changes in blood flow for these devices to detect. Participants will be observed using these imaging methods during vascular occlusion procedures. The main outcome measured is skin blood flow over a 4-week period. The study includes healthy volunteers aged 18 and older and involves non-invasive tests without treatment. Researchers will monitor blood flow changes and the performance of the imaging devices during the study period, which began in 2011 and is expected to continue until 2028.

This research investigates the safety and performance of various Vascular Grafts, including FlowWeave Bioseal, FlowNit Bioseal, FlowLine Bipore, and FlowLine Bipore Heparin, in treating arterial diseases such as dissection, aneurysm, intramural hematoma, penetrating aortic ulcer, contained rupture, and stenosis affecting the aorta or peripheral arteries in the lower limbs. It also covers the use of these grafts for debranching head vessels and as arterio-venous shunts. The study is observational and focuses on patients who have already received these grafts. Patients included in this study have received one of these Vascular Grafts as part of their treatment for arterial conditions. The study collects data from routine care, including interventions like open repair of the aorta and peripheral arteries. The data collection period lasts approximately 60 months plus an additional 6 months beyond the last follow-up visit, depending on each patients timeline. Participants medical records and observations gathered during standard care visits will be used for data collection. Researchers will monitor outcomes such as 30-day mortality, longer-term mortality at intervals up to 60 months, graft-related adverse events, hemorrhage, stenosis or occlusion, graft patency, pseudoaneurysm formation, infections, sepsis, and stroke occurrences. Patients will be observed throughout this period while continuing their usual care, providing a comprehensive view of graft performance and safety over time.

Researchers are investigating whether a coronary CT angiography CCTA-guided calcium modification approach can improve the treatment of patients with significant calcified coronary artery disease undergoing percutaneous coronary intervention PCI. This prospective, multicenter, randomized controlled trial compares the CCTA-guided strategy to the current standard of care using intravascular ultrasound IVUS-guided PCI. The study aims to see if the CT-based approach can improve procedural efficiency and stent results while maintaining similar clinical outcomes to IVUS guidance. Participants will be randomly assigned to one of two groups one using CCTA to inform calcium modification and plaque preparation before PCI, and the other using IVUS imaging to guide the procedure. Both groups undergo imaging to evaluate lesion characteristics before the procedure, with IVUS also used after stent placement to confirm correct implantation. The trial includes two main goals showing superiority in minimal stent area by IVUS and demonstrating non-inferiority in 12-month target vessel failure rates. During the study, participants receive imaging and PCI treatments according to their assigned group. Researchers will collect data on procedure time, radiation exposure, contrast volume, and detailed stent measurements. Clinical safety outcomes such as myocardial infarction and stent thrombosis will be monitored up to 12 months, along with patient-reported angina symptoms. Total participant involvement spans the procedure and follow-up assessments to evaluate both imaging and clinical outcomes.

This clinical trial is studying patients with combined pre- and post-capillary pulmonary hypertension CpcPH linked to left heart disease LHD. It aims to evaluate the safety and effectiveness of a new device called the Multi-Pole Pulmonary Artery Radiofrequency Ablation Enhancor System, compared to standard medical therapy. The study includes patients with chronic heart failure who are stable and already receiving the best available medical treatments for left heart failure. Participants will be randomly assigned to one of two groups the intervention group will receive pulmonary artery denervation PADN using the Enhancor System plus guideline-directed medical therapy GDMT, while the control group will undergo a placebo procedure plus GDMT. Before randomization, some operators may perform up to two roll-in PADN procedures to gain experience. Participants will be followed for 3 years, with clinical assessments at 1, 6, 12, 24, and 36 months. Control subjects who experience a primary efficacy endpoint event may cross over to receive PADN after 24 months if eligible. During the study, participants will undergo various assessments including heart function tests, walking distance tests, biomarker blood tests NT-proBNP, and quality of life questionnaires Kansas City Cardiomyopathy Questionnaire at several time points. Safety will be monitored closely, especially within 30 days after the procedure. Researchers will track heart failure events, hospitalizations, device implantations, heart transplantations, and cardiovascular deaths over the 3 years. Participants are expected to comply with medication and follow-up visits throughout the study.

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.