Active clinical trials for "Varicose Ulcer"

Background: Venous Leg ulcers are a frequent pathology in dermatology and complex in their management. At the origin of high health costs and strong repercussions on quality of life for patients, they require long management and may be subject to possible complications. In spite of appropriate treatment, 50-60% of these ulcers are not healed at 24 weeks. Purpose: Topical beta adrenergic antagonists have shown efficacy in wound healing. The purpose of this study is to evaluate the efficacy and safety of treatment of chronic venous ulcers with topical timolol.

Multi-center, prospective, interventional, uncontrolled open-label study evaluating the real-life use of KLOX LumiHeal BioPhotonic System in chronic wounds management (venous leg ulcers, diabetic foot ulcers, pressure ulcers).

This study compares the effect of adjuvant treatment of Low-level Light Therapy with conventional treatment in the tissue repair of venous ulcers in patients undergoing outpatient nursing consultation. For the evaluation of the cases clinical indicators of Nursing Outcomes Classification have been used.

A Multicenter, Prospective, Randomized, Open-Label Study with a Crossover Extension Option to Evaluate the Safety and Efficacy of GrafixPL for the Treatment of Chronic VLUs

Venous ulceration is a major burden on the NHS. Current treatment involves bandaging therapy which is replaced on a once or twice weekly basis. The Juxta-CuresTM device offers an alternative solution for the long-term treatment of patients with venous ulceration. This is a removable adjustable device with an inbuilt pressure monitor. The aim of this study is to determine whether the Juxta-Cures™ device provides at least equivalent ulcer healing for patients with venous ulceration compared to bandaging. Secondary outcome measures include whether the Juxta-Cures™ device improves patient compliance and quality of life compared to bandaging, and whether the Juxta-Cures™ device is cost effective compared to bandaging.

The primary objective of the study is to evaluate the efficacy of Prontosan® Wound Irrigation Solution and Prontosan® Wound Gel in the treatment of hard-to heal venous leg ulcers compared to control saline irrigation solution and inactive gel by showing a reduction in size over a 12 week period.

The investigators plan to perform an exploratory study to investigate the effects of electro-stimulation of the legs on the symptoms and clinical findings of post thrombotic syndrome (PTS), as well as quality of life of patients with PTS. The investigators theorize that electro-stimulation will provide both a mechanical benefit via muscular contraction and increased venous outflow from the affected extremity, as well as an anesthetic effect, which the investigators anticipate will translate into improved symptomatic outcomes, quality of life (QOL) benefits.

The purpose of this study is to evaluate the safety, tolerability and effectiveness of Thymosin Beta 4 administered topically in patients with Venous Stasis ulcers

This clinical trial is designed to evaluate the effect of XCell cellulose wound dressing for its ability to naturally (autolytically) remove nonviable tissue and create a healthy vascular wound bed. Results will compare venous ulcers treated with Xylos XCell cellulose dressing plus standard care to those treated with standard care alone. The hypothesis is that XCell will demonstrate more autolytic debridement than the standard of care.

Multi-center study on the effectiveness of treatment with a blue light medical device (EmoLED) in the reduction of ulcer surface in 10 weeks. The aim of BLUR clinical trial is to verify if the proposed treatment represents a valid and significant remedy for Chronic Venous Insufficiency ulcers. The effectiveness will be measured through the evaluation of the reduction percentage of the lesion area during 10 weeks of treatment comparing the lesion (or portion of it) treated with EmoLED versus the control lesion (or portion of it) treated only according to current Standards of Care(SOC). In the 10 weeks following the recruitment, the patient continues to follow the usual topical therapy with a frequency of once a week visit. The patient will be monitored up to the first event occurring: Complete healing or ten weeks. During the study, reports and evaluations will be made by medical staff on the device safety and usability. 90 patients will be recruited corresponding to the following criteria: Subjects suffering from venous, arterial and mixed skin ulcers and surgical dehiscence lesions; Presence of similar multiple lesions or lesions larger than 5 cm ; Men and women ≥ 18 years old; The patient must be able to understand the aims of the clinical study and provide informed consent in writing; Chronicity of the lesion: at least 8 weeks. The present clinical trial will be a multi-center prospective, controlled study with the aim of verifying the clinical efficacy of a portable battery-powered device based on blue LEDs. We expect to record at least 20% of the difference between treated lesion and untreated lesion on the same patient during observation time. The treatment, additional to the standard therapy for the patient, will be performed at each visit for 60 seconds on each 5 cm diameter sub-area of the selected lesion or on part of it. In case of multiple lesions, one will be treated with EmoLED and one will be selected as a control lesion. In case of a very extensive lesion, it will be divided into two and one half will be the control of the other. All lesions will be cleansed with saline solution and a surgical debridement will be performed with a scalpel if a slough/black base is present. Only then the treatment with EmoLED will begin. If the patient has more than one lesion at the recruitment time, and all lesions are less than 5 cm in diameter, the worst lesions will be treated entirely with the EmoLED device and the others will constitute the control lesions. The evolution of all lesions in the ten weeks of the study duration will be evaluated. If the patient has only one lesion greater than 5 cm in diameter at the recruitment time, the lesion will be divided into two parts along the major side and one half of the lesion area will be treated. The other half of the lesion will be masked with multi-layered sterile gauze during treatment. The point of division of the lesion into two parts will be indicated with an indelible marker and retouched at each visit. If, at the time of recruitment, the patient has more than one lesion with a diameter greater than 5 cm, all lesions will be divided into two along the major side and will be treated as in the previous case. After treatment with EmoLED, a hydrofiber dressing will be applied to the lesion. If clinical signs of infection occur, a hydrofiber dressing with silver will be applied. If necessary, compressive bandage of the limb will be carried out.