Active clinical trials for "Leg Ulcer"

Single-centre clinical study investigating the safety and tolerability of randomised, double-blinded, placebo-controlled ascending single doses of topically applied SoftOx Biofilm Eradicator (SBE) in patients with chronic leg wounds and of open-label once daily, twice daily, and thrice daily dosing of topically applied SBE for five days in patients with chronic leg wounds. The primary objective of the study is to assess the safety and tolerability of single and multiple doses of topically applied SBE in patients with chronic leg wounds. A secondary objective of the study is to assess changes in bacterial burden in the leg wound after treatment with SBE.

PURPOSE: to determine the impact of bee venom phonophoresis in accelerating ulcers healing. BACKGROUND: Bee venom (BV) phonophoresis has been suggested as a noninvasive treatment for a number of inflammatory conditions and in healing of ulcers. Ulceration due to vascular causes is often multifactorial and can be caused by both arterial and venous disease. Hypertension and atherosclerosis of the peripheral vessels lead to arterial disease associated with ischemic ulcers. Chronic venous insufficiency and the resulting venous hypertension cause venous ulcers. There are lack in knowledge and information in published studies about the efficacy of bee venom phonophoresis as physical therapy modality in accelerating ulcers healing. So, this study will be designed to provide a guideline about the efficacy of of bee venom phonophoresis in accelerating ulcers healing. HYPOTHESES: It will be hypothesized that: It was hypothesized that Bee venom phonophoresis has no or limited effect in accelerating ulcers healing. RESEARCH QUESTION: Does Bee venom phonophoresis an effect in accelerating ulcers healing?

The aim of our study was to evaluate the technical and clinical effectiveness of PTA in the management of ischemic foot ulcers. All consecutive patients presenting with a foot ulcer at the outpatient Vascular surgery clinic of our hospital were evaluated. If non-invasive parameters suggested peripheral arterial disease (PAD) anatomic imaging (CTA and/or DSA) was performed and a PTA was carried out when feasible during the same session. All patients were followed until healing, amputation, death, or for at least two years. Short-term and long-term clinical success of PTA was evaluated based on ulcer size and appearance. Patients with worsening ulcers after PTA underwent bypass grafting or amputation.

The goal of this study is to test MUSTCOOL, a home-based self-monitoring and self-management ulcer prevention intervention for patients with newly healed chronic venous leg and diabetic foot ulcers. Almost 90% of ulcers recur within 3 months of healing. During the six-month randomized clinic trial, skin temperature will be monitored daily, a maintenance dose of cooling gel pack or placebo will be applied three times weekly to the affected skin, and a bolus dose of cooling will be applied for 5 consecutive days if skin temperature becomes elevated. Outcomes on the incidence of leg ulcer recurrence, pain, physical activity and quality of life will be measured.

The aim of the study is to evaluate the performance of DURAFIBER Ag and to assess how many bacteria are present in infected wounds over an 8 week period.

Dose-response relationship study of S42909 on leg ulcer healing after oral repeated administration in patients with active venous leg ulcer.

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). At least 250 subjects will participate. The study is going to be conducted in approximately 50 sites in the United States and Canada.

Ulcers of the lower extremities, caused by chronic venous insufficiency and cellulitis are common in patients older than 65 years and cause a significant morbidity. Natural Matrix Bio polymer Membrane (NMBM) is a novel topical cosmetic cream containing a mix of natural waxes, sugars and lipids. The aim of this study is to test whether of Natural Matrix Bio polymer Membrane (NMBM) is effective as an adjunctive therapy to the treatment of venous stasis and post-erysipelas leg ulcers.

The main objective of this study is to assess the safety and the efficacy of EscharEx in preparing the wound's bed in patients with hard to heal venous leg ulcers, diabetic lower extremity ulcers and traumatic/post operative wounds. This study will be a multi-center, assessor blinded, randomized, controlled study intended to demonstrate superiority of EscharEx debriding treatment over the Gel Vehicle control treatment in patients with hard to heal wounds. 72 + 24 adults with >50% necrotic/slough/fibrin non-viable tissue on a hard to heal wound (venous leg ulcer, diabetic lower extremity ulcer or traumatic/ post operative wound) between 5 cm2 and 200 cm2 (surface area in stage 1) or 3 cm2 - 150 cm2 (in stage 2), will be enrolled into the study. Patients will undergo a 1 week screening period (2 visits) which will include: record of demographics, medical history and concomitant medications, vital signs, physical examination, clinical laboratory tests, wound photography and assessments and questionnaires (wound status and quality of life). During this period wounds will be treated by standard treatment per the decision of the physician. During this screening period, subjects whose study wound size (surface area) decreases by more than 20 percent will be excluded. Following completion of the screening process, eligible patients will be randomized to either EscharEx or Gel vehicle debridement treatments. In stage 1 (72 patients): Treatment will be performed for up to 10 applications or until complete debridement is achieved, whichever occurs first. In stage 2 (24 patients): Treatment will be performed for up to 8 applications or until complete debridement is achieved, whichever occurs first. Following each application the wound will be washed, photographed and assessed for wound size, removal of nonviable tissue and change in granulation tissue (by digital planimetry software), wound status, and safety parameters. Subsequent to each debridement treatment the wound will be dressed with moist-to-moist saline gauze (except when successive 24h or 48h treatments are performed, in the second stage). Following completion of the debridement treatment period, patients will be treated according to standard procedures and evaluated (wound assessments) once a week until complete wound closure for up to 12 weeks from last application (up to 12 visits). Only during the first stage of the study, for patients who achieved wound closure, additional 3 monthly (3 visits) follow- up visits of wound closure recurrence will be conducted. Quality of life (QoL) will be evaluated at the last follow-up visit - 3 months post wound closure follow-up period. For patients who didn't achieve wound closure only the 3 months FU visit will be conducted. For patients enrolled at the second stage, if wound closure was achieved at the 12 weeks follow-up, additional visit will be performed 2 weeks later to confirm wound closure.

Hypertensive leg ulcer, also called Martorell ulcer, represents 1 to 15% of leg ulcers in hospital. These ulcers are painful, long to heal, and hospitalization is sometimes necessary for analgesia and debridement of necrotic tissue. Strong opioids are often required, and are responsible of many side effects. Martorell ulcer arises predominantly in women over 60 years of age, with history of vascular disease, and therefore with a higher risk of adverse event. Pain is also part of the physiopathology, inducing a vasospasm which increases ulcer extension and ischemia. This is why pain management is one of the main challenge in treatments of these ulcers. Continuous nerve block of lower limbs are often used during per and postoperative orthopaedic surgery. Few adverse events and rare serious adverse events related to local anesthesic are reported (respectively <1% and <1/1000), and few adverse events related to catheter are reported (<1%). Its benefits have been proved on post-operative pain management and reeducation. The aim of this study is to assess analgesia provided by continuous sciatic nerve block, in patients with hypertensive leg ulcer, during hospitalization. Thirty patients will be enrolled on a 3-years period. They will receive a continuous sciatic nerve block with ropivacaïne 0,2%, during 7 days. Pain intensity will be assessed by 4 datas : numerating rating scale (NRS) at rest, during wound care, maximal and mean. These datas will be collected over two 3-days period : the first 3 days of hospitalization, in which pain treatment will be prescribed depending on pain intensity of the patient ; and the first 3 days of ropivacaïne treatment. The main evaluation criteria will be at least a 50% decrease of one of the pain NRS when receiving ropivacaïne. Time to healing, microcirculation evolution measured by Transcutaneous Oxygen Pressure (TcPO2), and quality of life of patients will be collected over a 6 months follow-up.