Active clinical trials for "Leg Ulcer"

In this open study, the primary objective is to study the efficacy and clinical outcome of the chronic wounds treated with this preparation for 8 weeks on 30 adults. Evaluation will be based on standardised photographs and clinical data. The secondary objectives are to evaluate the tolerance and side effects of the honey based preparation in the management of chronic wounds.

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.

Current treatment modalities for chronic leg ulcers are time consuming, expensive, and only moderately successful. Recent data suggest that creating a sub-atmospheric pressure by Vacuum Assisted Closure (V.A.C.®) therapy supports the wound healing process. Here, we studied the efficacy of V.A.C.® in the treatment of chronic leg ulcers prospectively.

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 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.

One in 300 Jamaicans have HbSS sickle cell disease, and of these, up to 70% will suffer from sickle cell leg ulcers (SCLUs). Of these, 24% will have a chronic SCLU (one lasting longer than 6 months). SCLUs heal very slowly, and sometimes they never close. SCLU patients would benefit from an economical, less painful, dressing option. In addition, because SCLUs often compromise education and employment opportunities, improving wound care for this population benefits their entire community. This three-armed evaluator-blinded randomized controlled trial will determine if a cut-to-fit food-grade plastic-based improvised dressing decreases pain, improves quality of life, and is safe, effective, and acceptable for managing SCLUs in Jamaica. The negative control will be usual practice, and the positive control will be the advanced wound dressing with the strongest evidence supporting its use in a tropical climate (polymeric membrane dressing). Patients with SCLUs will be actively recruited from three adjacent parishes. The first 120 SCLU patients meeting study criteria presenting to UHWI, Mona, will be randomized immediately after initial cleansing/debriding into group (1) current usual practice, group (2) improvised dressings, or group (3) advanced dressings. Data will be added to each participant's data collection tool weekly. Results will be reported using descriptive statistics and ANCOVA. The expected outcome is both improvised and advanced dressing superiority to usual practice. Because proposed improvised dressing materials are easily obtainable, their use would increase the capacity of wound patients to safely and effectively care for themselves. Signed informed consent will be obtained from patients/parents. Only principal research investigators will have access to participant confidential information. The literature review demonstrates that risks are not higher than usual practice.

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.

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?

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

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.