View clinical trials related to Ulcer Foot.
Filter by:This study is a prospective, multi-center, randomized controlled trial designed to collect patient outcome data on 2 commercially available SOC treatments for Diabetic Foot Wounds.
The planned study is a Randomized Controlled Monocentric Trial, which will provide evidence on whether early angiography in PTA readiness ("immediate treatment," within 48h) has advantages over the "standard of care", i.e., an elective procedure ("elective PTA") in terms of clinical endpoints such as wound healing and infection according to WiFI classification, amputation rate, "major adverse limb events" (MALE=amputation, reintervention of the vessel, death), but also systemic complications such as "major adverse cardiac and cerebrovascular events" (MACE=myocardial infarction, stroke, death, restenosis, severe cardiac and cerebrovascular complications). Furthermore, the impact of PTA on the local wound microbiome remains unclear. Altered microbiome composition in ulcers can lead to severe local and systemic infections and complications, including major amputations. Nevertheless, the specific significance of the wound microbiome composition in chronic ischemic ulcers in type 2 diabetes and the impact of PTA on the wound microbiome in type 2 diabetes is unclear. The exact timing for treating pAVD by revascularization in DFS after initial diagnosis is unknown and has yet to be fully understood.
To determine the effectiveness, compliance, patient tolerance, ease of use and safety of total contact soft cast in diabetic foot ulcers.
Diabetic foot disease is a global health problem. Diabetes affects over 450million people worldwide, expected to rise to 1 in 10 people by 2040. 60-70% will lose sensation in their feet and up to 25% will develop a diabetic foot ulcer (DFU - a wound on the foot). More than half of DFUs become infected requiring hospitalisation and 20% of infections result in amputations contributing to 80% of non-traumatic amputations performed in the developed world. DFUs cost the NHS £1billion in financial year 2014-15. A diabetic foot ulcer is a form of chronic wound. Chronic wounds are wounds that fail to progress through the normal phases of wound healing in an orderly and timely manner and become hard to heal. Almost all chronic wounds are known to have bacteria within and this is termed colonisation. Wounds can progress from being colonised to becoming infected. The concentration of bacteria can predict delayed healing or infection. This study aims to use a novel hand held device, Moleculight i:X™, in a pilot study to investigate the clinical effectiveness and decision making associated with its use in the assessment of DFUs. Moleculight i:X™ is a hand held device that emits violet blue light. By controlling distance from the wound and ambient light, Moleculight i:X™ identifies bacteria above a pre-determined concentration by identifying natural fluorescence in the bacteria cell wall. Patients attending a specialist DFU clinic will be screened and if eligible and consenting will be recruited. Patients will be randomised into two groups; those who receive treatments as usual (TAU) alone (in line with NICE guidelines) and those that receive TAU plus Moleculight i:X™ imaging. The main objective is to describe the proportion per group with healed DFUs at 12week follow up in these two comparable groups of 30 patients each.
This study is designed to evaluate the ability of Spatial Frequency Domain Imaging (SFDI) to measure perfusion in lower extremities and to understand how it might be used in a podiatry clinic.