Active clinical trials for "Foot Ulcer"

This is a pilot case/control clinical study on a group of outpatients with diabetic foot lesions aiming to verify the efficacy and safety of the Blue light photobiomodulation therapy with EmoLED medical device, in addition to standard therapy compared to the standard therapy alone, evaluating the percentage of healed lesions (which have reached complete and lasting re-epithelialization), the evaluation of the healing time and reduction of the ulcerated area during the time of observation, the perception of pain and the quality of life of the enrolled patients. The aim of this study is therefore to determine any differences in outcome between the two groups considered and, in particular, if the therapy of the group being treated is more effective than the standard therapy in terms of percentage of healed lesions, healing time, and reduction of the ulcerated area, pain perception, and quality of life, and is at least as safe in terms of occurrence of adverse events.

Purpose of this phase 1/2a study is to assess the safety and efficacy of administration of allogeneic human oral mucosal stem cells (hOMSCs) in patients suffering from chronic diabetic foot ulcers (DFU).

The TriO FITT device is designed to improve the symptoms of chronic diabetic ulcers. The mechanism of action of the device optimizes and combines the administration known supproting treatments to chronic diabetic ulcers. The treatment is astimated to improve the wound conditions of acute and chronic diabetic wounds.

The aim of this study is to evaluate the chance of non-healing diabetic foot ulcers repair by improving the condition of lack of oxygen or hypoxia in the wound area caused by diabetes using methylene blue along with the use of platelet-rich plasma-fibrin glue as an effective treatment for wound healing.

A Prospective, Non-Randomized, Multi-Center Observational Study To determine the safety and effectiveness of InnovaMatrix AC porcine placental ECM therapy for the treatment of chronic, non-healing diabetic foot ulcers (DFUs) Eligible subjects will be treated with a weekly application of sterilized, porcine placental ECM followed by standard of care wound therapy and offloading

The purpose of the PULSE study are the followingL A.To perform post market clinical follow up (PMCF) on safety and efficacy: Safety: To confirm transient short-terms side effects and verify long-term/outstanding risks. Efficacy: To confirm the performance of PLASOMA, i.e. the beneficial effect on bacterial load. B. Determine the effect of PLASOMA on wound surface area. A secondary purpose is to examine the beneficial effects of PLASOMA on wound healing and to perform a health technology assessment (HTA). This clinical study will be an open label two-armed randomized controlled trial (RCT), performed at at least three sites (multi-center) in the Netherlands. The two arms are: Control group: Standard wound care for 12 weeks or until healing, whichever occurs first; Treatment group: Standard wound care + PLASOMA treatment for 12 weeks or until healing, whichever occurs first. The frequency of PLASOMA treatment will be determined by the treating (para)medical professional based on the number of visits they would schedule for the standard wound care at the study site. For all study subjects, the treatment frequency will be at least once per week (in order to have enough treatments for safety evaluation) and should not exceed once per day. Follow up (FU) will be performed at three timepoints for both arms: FU1: 2 weeks after end treatment period FU2: 12 weeks after end treatment period FU3: 12 months after start treatment.

A Randomized Controlled Multicenter Clinical Trial, Evaluating the Efficacy of Dual Layer Amniotic Membrane (Artacent®) and Standard of Care versus Standard of Care alone in the healing Chronic Diabetic Foot Ulcers. Multi-center, open label, randomized controlled trial. Study is estimated to require 12 months from first subject enrolled to last subject visit.

The goal of this study is to improve the therapeutic management of diabetic foot ulcers (DFU). The main questions to answer are if a program of non-weight bearing exercise helps the DFU heal faster than standard wound care. This randomized clinical trial will determine how blood flow to the ulcer and whole body metabolism may be improved with exercise. Participants will be randomized to either exercise + standard wound care or standard wound care alone and undergo testing for leg blood flow, fitness and measures of metabolism through blood draws. The intervention period is 6-weeks. Eligible participants must have an existing foot ulcer uncomplicated by infection and be medically cleared to exercise.

The goal of this clinical trial is to assess the impact that the NanoSALV wound dressing can have on managing severe chronic wounds and feasibility for patients, providers, and health systems in different health care settings (community care, continuing care and in-patient care). The main questions it aims to answer are: What is the cost-savings of using NanoSALV? Do care providers perceive NanoSALV to be better, worse or the same as the standard of care in terms of usability and efficiency? Does NanoSALV increase autonomy and competence of wound self-management for care providers/patients? Were patients more satisfied, less satisfied or just as satisfied with NanoSALV compared to the standard of Care? Does NanoSALV reduce healing time for chronic wounds compared to standard of care? The sequence and duration of the trial is as follows: Required data will be collected at enrollment to provide a baseline (Day 0) measure. The patient will receive standard of care treatment for four weeks with dressing changes as per the standard care pathway. In the following four weeks the patient will receive the NanoSALV dressing treatment and dressing changes done every 48 - 72 hours as required. Wound assessments will be done weekly with wound images captured by Aranz Medical's Silhouette Star 3D medical camera that digitally takes measurements. A patient satisfaction survey will be collected post-control and post-intervention periods One week after completing the study the patient/surrogate will be contacted or a survey link will be sent to them regarding adverse events and to see what wound dressing they continued to use. Semi-structured interviews and observations will be done with care providers/patients and healthcare professionals in the control period to explore the perspectives on the current state of chronic wound management, and in the intervention period to evaluate the perceptions on the usability of the intervention.

Application of autologous Platelet Rich Plasma (PRP) has been a major breakthrough for the treatment of diabetic foot ulcers, as it provides the necessary growth factors which enhance tissue healing. Human umbilical cord blood platelet lysate (UCB-PL) contains a supraphysiological concentration of growth factors. The aim of the study is to evaluate the efficacy of umbilical cord blood platelet lysate (UCB-PL) gel for the treatment of diabetic foot ulcer.