Active clinical trials for "Varicose Ulcer"

It is hypothesized that application at 4-week intervals of the human umbilical cord tissue TTAX01 to the surface of a well debrided, nonhealing venous leg ulcer (VLU) will result in a high proportion of wounds showing complete healing within 12 weeks of initiating therapy. This open label pilot study provides a framework for a larger, controlled study. The purposes for conducting this study are to evaluate the functionality of the protocol and to obtain an estimate of product safety and efficacy when applied according to the protocol instructions, and measured according to the stated endpoints.

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: 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. 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. 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. 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.

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).

The primary objective of this post market clinical follow-up (PMCF) investigation is to confirm the safety and performance of Avance®Solo and Avance®Solo Adapt NPWT Systems in low to moderate exuding chronic wounds when used in accordance with the Instructions for Use, for up to 28 days.

Evaluation of the efficacy (wound epithelialization and time to closure) and safety (emergence and nature of adverse event) of the new URGO BD001 compression system versus a reference compression in the local treatment of venous or mixed predominantly venous leg ulcers: prospective multicenter, randomized controlled, open-label clinical study

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.

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.