View clinical trials related to Varicose Ulcer.
Filter by:Study Summary A leg ulcer is a long-lasting (chronic) sore that takes more than two weeks to heal. The majority of leg ulcers are caused either by problems with the veins in the legs; these are called 'venous leg ulcers' (VLU), or a combination of both venous and arterial disease which affects the veins and arteries in the leg; these are called 'mixed aetiology ulcers'(MLU). Venous and mixed aetiology leg ulcers are usually treated by applying a simple non-stick dressing to the ulcer with a firm compression bandage applied on top. These bandages are designed to squeeze the legs and encourage blood flow towards the heart. Before this treatment starts, a patient may undergo tests to check the flow of blood in the leg arteries is adequate. This ensures that compression bandaging can be safely applied to assist wound healing without compromising arterial blood flow. Most venous and mixed aetiology leg ulcers heal within three to four months if they're treated by a healthcare professional trained in compression therapy for leg ulcers. However, some ulcers can be more problematic and may persist for many months or even years despite being treated with the gold standard treatment of compression bandages. We therefore need to find more ways of helping these problematic ulcers to heal. Intermittent Pneumatic Compression (or IPC) is another way of compressing legs to try and improve the circulation. IPC consists of a sleeve or garment which is applied to the leg. The sleeve is connected to a pump which gently inflates and then deflates it to squeeze the leg in a massage like manner. The IPCOTT study aims to find out if a new IPC device, known as the WoundExpress can help to heal leg ulcers. The WoundExpress has a sleeve that patients put around the thigh, like the one applied to the arm when people have their blood pressure taken. Users need to be either sitting with their legs raised or lying down when using the device. Pressing the 'start' button on the pump causes the sleeve to automatically inflate with air for 2 minutes, until it reaches a pressure of 60 mm/Hg (this is low compared to the pressure used when measuring blood pressure; most patients find it very gentle and comfortable). After the 2-minute inflation, the sleeve will automatically deflate for another 2 minutes, where no compression is applied to the thigh. These 4-minute inflation and deflation cycles will repeat whilst the device is in use. People who take part in the study will be randomly allocated to Group A or Group B. Patients in Group A will continue to receive their usual wound care but will also be provided with a WoundExpress device to use for 2 hours per day for a 16-week period. Patients in Group B will continue to receive their standard wound treatment only for the 16-week study period (patients in Group B will be offered the chance to use the WoundExpress device for a 16-week period after the study has ended). All patients taking part in the study will be asked to attend their Wound Clinic for a study review once every two weeks during the study period. At these visits, a research nurse will take measurements and photographs of the ulcer(s) and participants will also be asked some questions about how they have been feeling since using the device. Patients who have been given a WoundExpress device will also be asked to keep a diary recording when they use the device and how they found it. When the study is complete, results will be analyzed to find out if there was any difference in ulcer healing rates between Group A and Group B.
The aim of this post market clinical follow up (PMCF) study is to confirm the performance of Suprasorb® A + Ag wound dressing and rope, to collect safety data regarding expected adverse events and to detect potential unexpected adverse events associated with use of Suprasorb® A + Ag wound dressing and rope within the certified indications and under the conditions of routine use.
Randomized Controlled Trial to determine if the outcomes of sclerotherapy of the ulcer bed alone differ from a combination of ablation and sclerotherapy injections.
The goal of this clinical trial is to assess the impact that the NanoSALV wound dressing can have on managing severe chronic wounds and feasibility for patients, providers, and health systems in different health care settings (community care, continuing care and in-patient care). The main questions it aims to answer are: 1. What is the cost-savings of using NanoSALV? 2. Do care providers perceive NanoSALV to be better, worse or the same as the standard of care in terms of usability and efficiency? 3. Does NanoSALV increase autonomy and competence of wound self-management for care providers/patients? 4. Were patients more satisfied, less satisfied or just as satisfied with NanoSALV compared to the standard of Care? 5. Does NanoSALV reduce healing time for chronic wounds compared to standard of care? The sequence and duration of the trial is as follows: - Required data will be collected at enrollment to provide a baseline (Day 0) measure. - The patient will receive standard of care treatment for four weeks with dressing changes as per the standard care pathway. - In the following four weeks the patient will receive the NanoSALV dressing treatment and dressing changes done every 48 - 72 hours as required. - Wound assessments will be done weekly with wound images captured by Aranz Medical's Silhouette Star 3D medical camera that digitally takes measurements. - A patient satisfaction survey will be collected post-control and post-intervention periods - One week after completing the study the patient/surrogate will be contacted or a survey link will be sent to them regarding adverse events and to see what wound dressing they continued to use. Semi-structured interviews and observations will be done with care providers/patients and healthcare professionals in the control period to explore the perspectives on the current state of chronic wound management, and in the intervention period to evaluate the perceptions on the usability of the intervention.
Compression wraps treat venous leg ulcers when applied correctly. Often, clinicians apply the wraps at the wrong compression, or the wrap loosens, stopping clinical benefits. The study aims to show the feasibility of a smart compression prototype to maintain a set compression level in healthy volunteers. Each volunteer will wear the prototype device on one leg and a standard compression wrap on the other. Volunteers will pump their calves, walk, lie down, and stand at zero, one, and four hours. A pressure sensor placed over each calf will record the compression level during the activities. Volunteers will provide subjective feedback on each device concerning comfort and usability. After four hours, researchers will remove the standard wrap. Volunteers will use the prototype device during daily activities for three days. During the three days, the volunteers will complete a daily journal. The journal will capture the user experience and time the volunteer used the device. A final site visit allows researchers to conduct exit interviews and download the history of applied compression. Researchers will use the data to show that the prototype device maintains therapeutic compression and prove the usability of the device.
The goal of this clinical trial to follow the progress of wounds in those with chronic venous leg ulcers while using a non-bordered foam dressing. The main objective is to follow the progress of these wounds over time from initial visit to each follow-up visit. Participants will be asked to wear the dressing for up to 6 weeks of treatment or until healed, changed at every one-week interval.
The goal of this clinical trial is to follow the progress of wounds in those with venous leg ulcers and diabetic foot ulcers while using an absorbent dressing called Mepilex Up. The main objective is to follow the progress of these wounds over time from initial visit to each follow-up visit. Participants will be asked to wear Mepilex Up dressing for up to 6 weeks of treatment or until healed, changed at every one-week interval.
The purpose of this PMCF study is to evaluate the safety and efficacy of ChitoCare medical Wound Healing Gel for the healing of chronic wounds. The study will enroll patients with diabetic foot ulcer, venous ulcer or pressure ulcer. Patients will be randomly assigned to an active or control group. The active group will apply the gel to the wound, in addition to the standard of care, while the control group will receive only standard care. The study will last from 3 to 18 months for an individual patient (15-month recruitment period and 3 months of follow-up after the last patient is enrolled) or until event occurrence (complete wound healing/exclusion from the study). The study envisages four visits: Visit 1 - Screening and Inclusion visit, Visit 2 (after 4 weeks), Visit 3 (after 12 weeks) and Visit 4 - End of Study Visit: The final visit will take place when the event occurs (complete healing/exclusion from study). On each visit, the patients will have their wound photographed and assessed after debridement. Adverse events will be followed throughout the whole study.
The aim of the study is to assess safety, tolerability and preliminary efficacy of XSTEM-VLU when administered as a single topical dose to patients with difficult-to-heal venous leg ulcers. The study is randomised and the patients will receive either XSTEM-VLU or vehicle as add on to standard wound care. The patients will be followed weekly for 10 weeks after treatment. At 4 months after treatment, the patients will return to the clinic for an end-of-study visit.
Varicose veins of lower extremities can lead to adverse consequences such as ulceration and hemorrhage, which seriously endangering the physical and mental health and quality of life for patients. The aim of this study is to explore the potential risk factors of venous ulceration in patients with varicose veins of lower extremities based on a case-control study, and to provide a reference for personalized treatment.