View clinical trials related to Leg Ulcer.
Filter by:This study evaluates the effect of additional hyperbaric oxygen therapy after lower extremity amputation. The patients will be randomized after amputation to either a treatment group receiving hyperbaric oxygen therapy, or control group.
The main purpose of the study is to evaluate the effect of KLOX BioPhotonic System (composed of KLOX LumiHeal Gel and KT-L Lamp) on the expression of wound biomarkers in the treatment of venous leg ulcers (VLU). Patients will be randomized in three groups, two different dispensing schedules of KLOX BioPhotonic System in addition to Standard of Care (SOC) will be used, and SOC alone.
This study is a multicenter, randomized, controlled, open-label trial designed to evaluate the safety and efficacy of DermACELL in subjects with a single target chronic venous leg ulcer (VLU).
This study is a multicenter, prospective, randomized, placebo controlled, adaptive design study performed to assess the safety and the efficacy of 5% EscharEx (EX-02) compared to Gel Vehicle (placebo) and non-surgical standard of care (NSSOC), in debridement of Venous Leg Ulcers (VLU) (in a ratio of 2:2:1) in debridement of VLU. The main objective of this study is: To assess the safety and the efficacy of EscharEx (EX-02 formulation) compared to Gel Vehicle (placebo) and non-surgical standard of care (NSSOC), in debridement of Venous Leg Ulcers (VLU). 120 randomized adult patients with VLU that fail to heal for 4 weeks to 2 years, and with >50% non-viable tissue (necrotic/slough/fibrin) on the VLU. The maximum number of patients to be enrolled is 160. The total duration of the study of each participating subject is up to 17 weeks: screening (1 week) + Daily visit period (up to 2 weeks) + Twice-weekly visits period (2 weeks) + Weekly visits period (10 weeks) + closure confirmation (up to 2 weeks, if applicable). Each patient will go through 4 periods during the trial: 1. Screening period (2 visits, 7 [+2] days apart). Including: recording demographics, medical history and concomitant medications, vital signs, physical examination, clinical laboratory tests, wound photography and assessments and questionnaires (pain, wound status and QoL). During this period, wounds will be treated by standard treatment (e.g. appropriate dressing, compression bandage) per investigator discretion, with the exclusion of mechanical and surgical debridement. During the one week screening period, patients whose wound size (surface area, as measured by eKare inSightTM) decreases by more than 20 percent will be excluded. 2. Daily visits period (up to 8 daily site visits within up to 14 days): During the Daily visit period, the patient will arrive daily to site visits. During each visit, adverse events, concomitant medication, vital signs and pain will be recorded, the wound will be washed, photographed and assessed for wound size (by eKare inSightTM), % of non viable tissue (by clinical assessment), and wound healing status (assessed clinically). Eligible patients will be randomized into one of the study arms: EX-02, or Gel Vehicle (Placebo), or NSSOC in a 2:2:1 ratio. Patients will be treated with up to 8 daily 24±3 hours applications or until complete debridement is achieved, whichever occurs first. On the weekends between treatments of EX-02 or Gel material, the wound will be dressed with a compatible dressing, and by compression therapy. Patients treated with NSSOC continue using NSSOC during the weekend according to label or instructions for use, and compression therapy. 3. Twice-weekly visits period (4 visits within 14 days): the patients will be followed twice weekly for two weeks, (4 visits within 14 days). During each visit, safety parameters will be recorded (AEs, concomitant medications, pain, vital signs), the wound will be washed, photographed and assessed for wound size (by eKare inSightTM), % of nonviable tissue (by clinical assessment), and wound healing status (assessed clinically). The investigator will clinically assess complete debridement, upon achieving a viable wound bed after removal of all non-viable tissue, suitable for initiation of the wound healing stage. 4. Weekly visits period (up to10 visits within up to 10 weeks): patients will be followed once weekly for 10 weeks or until complete wound closure was achieved, (up to10 visits within up to 10 weeks). During each weekly visit, safety parameters will be recorded (AEs, concomitant medications, pain, vital signs), the wound will be washed, photographed and assessed for wound size (by eKare inSightTM), % of nonviable tissue (by clinical assessment), and wound healing status (assessed clinically). The investigator will clinically assess complete debridement, upon achieving a viable wound bed after removal of all non-viable tissue, suitable for initiation of the wound healing stage. Complete wound closure defined as skin re-epithelialization without drainage or dressing requirements confirmed at two consecutive study visits, 2 weeks apart will be assessed clinically. Thus, if closure occurs close to the end of weekly visit period, i.e. on 9th or 10th visit of the weekly period, an additional confirmation visit will be performed 2 weeks later.
The purpose of this study is to test the efficacy of an oral, nutrient intervention containing the bioactive components of fish oil to promote healing of chronic venous leg ulcers (CVLUs) by reducing the chronic inflammation at wound sites that prevents healing progression. If this systemic, nutrient intervention is found to alter the microenvironment of CVLUs, the science of wound healing and care of patients with CVLUs will be vastly improved.
This study in venous leg ulcer (VLU) patients will evaluate the use of Cirvo™ therapy for the treatment of VLU when applied for a minimum of two hours daily for up to 12 weeks.
Approximately 200 patients (100 in each treatment group) nationally with chronic venous leg ulcers will be randomized to GrafixPL™PRIME plus standard compression therapy or standard compression therapy alone for up to 12 weeks in order to compare the clinical outcomes between the two groups. Specifically, at this Georgetown site, approximately 30 subjects will be recruited.
Explorative study of function of a moisture sensor on top of a superabsorbent wound dressing on exuding leg ulcers.
Pilot study of a soft, flexible pressure and temperature sensor
Venous leg ulcers (VLU) are slow healing wounds. They have a high recurrence rate and are associated with pain, infection, smell and exudate. 60% of VLU become chronic. Current therapeutic approaches are multifaceted and focus on improving wound healing and preventing recurrences. As those approaches include compression therapy, leg elevation, specific exercises for the foot/ ankle region and a protein rich diet/ nutrition plan a multidisciplinary team of health care professionals such as nursing, physiotherapy, occupational therapy and nutrition specialists. Most persons with VLU have a knowledge deficit in regards to therapeutic measures and hence have difficulties with adherence to treatment protocols/ management plans. It is of utmost importance, and best practice, that the treatment team provides effective patient education and support during the learning phase. However, there is little evidence and no published studies that describe and evaluate effective multidisciplinary educational interventions that target compliance/ adherence to the treatment plan in patients with VLU. Therefore the investigators propose to develop an evidence-based interprofessional educational intervention and evaluate its feasibility first in a pilot study and subsequently in a randomized controlled trail. Method/Design: Firstly, the development of an evidence based education intervention in collaboration with an expert panel and secondly a randomized controlled pilot study in one wound care outpatient clinic is proposed. Data will be analyzed using SPSS version 23. Univariate and bivariate analysis will be conducted according to the data level and distribution of the data. Discussion: The TIEIVLU will firstly develop an evidenced based educational intervention and secondly examine the feasibility of implementing this education intervention in a realistic care context in patients with VLU. The results will inform the final design of a following RCT which will examine the effectiveness of the educational intervention. An intervention that enhances patient adherence to therapy and hence reduces the negative outcomes of VLU would be beneficial to individual patients as well as society as a whole.