View clinical trials related to Venous Leg Ulcer.
Filter by:This is a prospective, randomised, open label, controlled pilot study to evaluate the safety and preliminary effectiveness of the ReCell Autologous Cell Harvesting Device (ReCell) for the management of chronic leg ulcers associated with venous insufficiency. Outcome will be compared between study participants receiving standard care (debridement, compression therapy) and participants receiving ReCell in addition to standard care.
This study is being done to find out if an investigational product called HP802-247 can help people with venous leg ulcers. Investigational means that HP802-247 has not been approved by the U.S. Food and Drug Administration (FDA). This research is being done to compare the efficacy of HP802-247 plus compression therapy against Vehicle plus compression therapy in achieving complete wound closure over the 16-week treatment period. Vehicle looks the same as HP802-247 but contains no cells. At least 250 subjects will participate. The study is going to be conducted in approximately 50 sites in the United States and Canada.
This observations safety study is intended for subject who participated in the 802-247-09-029 study with the investigational product HP802-247 for venous leg ulcers and received at least one application of HP802-247 or Vehicle (an inactive substance). This study is being done for the following purposes: 1. to identify new adverse events, 2. to examine ongoing adverse events not resolved in subjects who participated in the 802-247-09-029 trial, 3. to record wound status, and 4. to determine if there are differences in Health Related Quality of Life (HRQoL) associated with the treatment assignment from the 802-247-09-029 Trial. Investigational means that HP802-247 has not been approved by the U.S. Food and Drug Administration (FDA).
This study is being done to find out if an investigational product called HP802-247 can help people with venous leg ulcers. Investigational means that HP802-247 has not been approved by the U.S. Food and Drug Administration (FDA). This research is being done to compare the efficacy of HP802-247 plus compression therapy against Vehicle plus compression therapy in achieving complete wound closure over the 12-week treatment period. Vehicle looks the same as HP802-247 but contains no cells.
The venous ulcer due to venous insufficiency causes an important morbility to those people suffering from this condition. Most of therapies available under the obligatory health plan (POS, acronym in spanish) to date cover the cleaning of the ulcerous lesion and its medical handling using saline solutions, topical antibiotics and elastic dressings, implying an important intake from health resources due to its chronicity and the delay in ulcers healing, which usually takes periods ranging from 6 months to several years. therapeutical alternatives, which can guarantee optimal, fast and persistent in time healings, should be identified. The aim of this study is to determine the percentage of healing of active venous ulcers (using a clinical, etiological, anatomic and physiopathologic classification (CEAP), C6) following ultrasound-guided foam sclerotherapy of superficial venous reflux in patients with chronic venous ulceration after six months from the intervention, compared with conservative medical handling. The investigators expect that the ultrasound-guided foam sclerotherapy of superficial venous reflux will diminish the time of ulcer healing compared with standard handling.
Chronically venous ulcer in lower extremities is a permanent and disabling disease. Venous insufficience is the main cause of chronic ulcer. There is a high prevalence and frequency of the disease, primarily among elderly people. Recently, electromagnetic field therapy has been tested on various diseases in musculoskeletal system with a beneficial effect. In recent years, there has been an increasing interest in using electromagnetic field therapy to treat chronically venous ulcer. The hypothesis of the investigators is that the electronic magnetic field therapy improves the healing process and reduces pain for patients suffering from chronically venous ulcer. The investigators assume that the bioactivity is affected by a cellular response which affects the DNA synthesis, transcription og protein synthesis.
The purpose of this study is to determine whether the EpiFix human amniotic membrane is effective in the treatment of venous leg ulcers.
Leg vein circulation problems can damage the skin of the lower legs, especially around the ankles, by making it discolored, hard, itchy, red, and swollen. Ulcers often develop. Inflammation is often present in the damaged skin. This study will test whether using a special low compression, cooling, boot-like gel wrap placed around the damaged skin of the lower legs will improve the skin circulation and prevent leg ulcers. The study hypothesis is: A cryotherapy, low-compression cooling gel wrap (CW) plus usual care (UC) (leg elevation, compression stockings) intervention compared to a low compression non-cryotherapy "sham" wrap (NW) plus UC will reduce tissue blood flow (perfusion units) and decrease the incidence of venous leg ulcers (VLUs) during the 9-month study period in individuals with Stage 4 and 5 venous insufficiency.
OBJECTIVES: Main objective: To evaluate the effectiveness of plasma rich in growth factors (PRGF) in the treatment of patients with venous ulcers. Secondary objective: To evaluate the safety of plasma rich in growth factors in treating patients with venous ulcers. DESIGN: Randomized, open clinical trial in parallel groups, controlled with conventional treatment. SAMPLE: Over age patients, of primary care centers of Vitoria, with at least one venous ulcers of 6 or more weeks of evolution and 0.5-6 cm of diameter. INTERVENTION: 1-Experimental group: Autologous PRGF administrated once a week (day 1) + conventional treatment administrated twice a week (days 1 and 4)for 12 weeks of treatment, but in those cases where there has been no complete healing in this period, patients will continue the same management protocol to get it. 2-Control group: Conventional treatment twice a week (days 1 and 4)for 12 weeks of treatment. Conventional treatment includes: Cleaning and debridement of the wound, the application of corresponding dressing, and using of antibiotic if necessary in each visit. STATISTICAL ANALYSIS:The primary outcome analysis was done by logistic regression. The crude model and the adjusted model (for confounding variables)will be built. The healing time of ulcers (in days) were analyzed using the Kaplan Meier survival analysis and the corresponding comparison using the log rank test.
Calcium alginate dressings with silver have been found to be safe and effective for use for leg ulcers. The primary objective is to compare Restore Calcium Alginate Dressing, Silver to AqualCel Ag Dressing on the following parameters: No further progression toward infection (bioburden), ease of application and removal, and percent progression to closure. The secondary objective is to obtain photographic documentation of the leg ulcers during the course of the study.