View clinical trials related to Ulcer Foot.
Filter by:The purpose of this study is to evaluate the efficacy of four dehydrated complete human placental membrane, also defined as Cellular, Acellular, Matrix-like Products/skin substitutes, plus SOC versus SOC alone in achieving complete closure of hard-to-heal diabetic foot ulcers over 12 weeks using a modified platform trial design.
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.
Supra SDRM® is FDA-cleared as a dressing for treating partial and full-thickness wounds. It is a dermal substitute that provides a barrier and an ECM-like structure to help accelerate wound healing. SUPRA SDRM® has 510k approval for partial and full-thickness wounds and has shown promising results in preliminary animal studies. The purpose of this clinical evaluation is to collect and compare outcomes data from patients with UT 1A diabetic foot ulcers treated with a commercially available dermal substitute, Supra SDRM®, as compared to an advanced standard of care (Fibracol Plus). Patient outcomes, including time to heal, healing by 12 weeks, direct costs, and infection rate, will be compared at the end of the study.
The objective of this observational study is to predict healing at 26 weeks after the first visit in patients affected by the first ulcer, by means of combined data monitoring of Laser Speckle Contrast Imaging (LSCI) and temperature measurements during patient visits in hospital. In order to achieve this objective, study aims to produce a logistic regression model and then evaluate its prognostic ability by means of the area under the curve (AUC) of the receiver-operating-characteristics (ROC) curve. Patients with diabetes mellitus and suffering from ulcer and receiving health care will undergo regular microcirculatory measurements including LSCI scans in and around the ulcer location and thermography.
Diabetes education and self-management support can be delivered via mobile phones. This protocol aims to assess the feasibility and acceptability of Well Feet, a conversational agent, as a diabetic foot care companion. By utilizing feedback and responses to evaluative questions posted on the app's interface, the investigators intend to examine the app's technical, functional, and operational feasibility.
The study will examine the effectiveness of a decellularized dermal matrix (i.e., DermGEN™) in improving wound healing, quality of life and associated costs of treatment of DFUs in First Nations people living in the Northwestern Ontario Communities. First Nations people with active diabetic foot (DFU) ulcer attending a wound care clinic located at the Rainy River district office. An interventional, two-arm, randomized, prospective study of (1) standard of care (control) vs. (2) DermGEN™ - a decellularized dermal matrix (treatment) will be used in the treatment and management of DFU. Patients will be randomized to each arm (n=60 per arm) based on power calculations using data from our Pilot study.
This is a prospective, multi-center, open label study evaluating the performance of PICO14 NPWT in the management of chronic open wounds (pressure ulcers, venous leg ulcers, diabetes related foot ulcers), dehisced surgical wounds and closed surgical incisions. The study comprises the Post Market Clinical Follow-up (PMCF) for a new variant of an established product. PICO 14 is based on another dressing called PICO. The primary objective is to evaluate functional performance of PICO 14 through verification of delivery of negative pressure and wound exudate management.
The aim of this feasibility study is to evaluate a 12-week exercise intervention in people with an active diabetic foot ulcer through pre-defined research progression criteria (participant recruitment and retention, duration of the collection of outcome measures, adherence to the exercise programme, and adverse events), besides participant and physiotherapist feedback, self-reported outcomes and objective measurements in preparation for a potential future RCT. The primary study hypothesis is that exercise therapy for people with an active diabetic foot ulcer will have high participant recruitment and adherence to treatment and that it does not affect wound healing negatively.
The Patient Empowerment Study is an observational longitudinal study among adults with diabetic foot ulcer (DFU). The scope of this study is to better understand how a patient's DFU disease process and usage of the Podimetrics System can impact patient health-related quality of life. Health-related quality of life will be measured by both the generic 36-item Short-Form Health Survey (SF-36) questionnaire and the ulcer-specific Diabetic Foot Ulcer Scale Short Form (DFS-SF) questionnaire.