View clinical trials related to Diabetic Foot.
Filter by:The goal of the Cellular and Tissue Based Therapy Registry (CTPR) for Wounds is to provide real world patient data from electronic health records submitted to meet Stage 2 Meaningful Use in order to understand the value of these products among patients with chronic wounds and ulcers. Randomized, controlled trials to establish product efficacy routinely exclude patients with the co-morbid conditions common to patients seen in usual clinical practice and thus the results of these RCTs tend to be non-generalizable. Little is known about the effectiveness of CTPs among typical patients.
To evaluate a recently developed non-invasive infrared thermal camera called Diabetic Foot Ulcer Prevention System (DFUPS) in a clinical setting by studying healthy volunteers.
The current trial aims to compare the assessment of diabetic foot ulcers by fluorescence image guidance to standard practice. The device will be used to acquire fluorescence images of diabetic foot ulcers: when wounds are illuminated by violet/blue light, most pathogenic bacterial species emit a unique red fluorescence signal. The device is intended to be used as part of the clinical assessment process, which may include visual assessment, signs of heat or high temperature, the presence of exudate, and redness in the area. Images will guide the clinician to inspect, sample or further evaluate areas where fluorescing bacteria is present. This study will allow us to determine the benefit of fluorescence image-guided procedure as compared to standard clinical practice to assess bacterial burden in diabetic foot ulcers. Microbiological swabbing under standard practice and fluoresce-guided imaging will be performed in order to compare the two techniques.
This is a pilot study which is intended to collect data to calculate an adequate sample size for a larger registered clinical trial. Eleven subjects were enrolled at The Ohio State University; we intend to enroll 29 more subjects at Indiana University. Due to the small sample size this study will primarily be a feasibility study that will attempt to measure and evaluate differences in the relative theoretical costs of the intervention of topical oxygen therapy on this population and subsequently compare outcomes in areas such as overall health improvements and cost effectiveness.
A prospective, randomized, controlled, clinical study to establish clinical based evidence of PRP Concepts Fibrin Bio-Matrix and compare its performance with the usual and customary practice for the treatment of Wagner 1 or 2 DFUs.
The investigators plan a randomized clinical trial of 150 patients with infected diabetes-related lower extremity wounds to compare the clinical and economic effectiveness of negative pressure wound therapy with continuous irrigation and negative pressure wound therapy without irrigation. The investigators will enroll 150 patients from two centers: The University of Texas Southwestern University Hospital and Parkland Hospital. The investigators will screen and enroll patients with wounds in the inpatient setting. Patients will randomized to receive traditional NPWT or NPWT with continuous irrigation while they are hospitalized. The average hospitalization for patents that receive NPWT is 13.3 days. Patients that do not have their wound surgically closed during hospitalization will be discharged with negative pressure wound therapy without irrigation for up to a total of four weeks of therapy. After discharge from the hospital, subjects will be seen twice weekly by home health, and the investigators will evaluate subjects in clinic every 7 days (±7 days) for a total of 16-week period or until the wound heals.
Mesenchymal stem cells with multidirectional differentiation potential,autologous stem cell transplantation into ischemic foot, make its differentiation to form new blood capillary, improve and restore the local blood flow.
This is a prospective study of Veterans with chronic lower extremity or diabetic foot ulcers who will be randomized to either a Larval Debridement Therapy group (Biobags every 4 days x 2 applications) or a Sharp Debridement Therapy group (standard or control weekly x 2) during an 8 day study period.
More than 100 hospital based outpatient wound centers in the USA and Puerto Rico agree to transmit structured data on all patients followed with chronic wounds and ulcers (e.g. diabetic foot ulcers, venous ulcers, pressure ulcers, arterial ulcers, surgical wounds, and traumatic wounds). Data are collected at point of care including adherence to wound care quality measures developed by the USWR as a Qualified Clinical Data Registry (QCDR).
The PDA-002-DFU-002 trial is a Phase 2, multicenter, randomized, double blind, placebo controlled, dose range finding study. The study will enroll approximately 133 subjects in four treatment groups. The primary objective of the study is to assess the efficacy and safety of PDA-002 administered intramuscular (IM) in subjects who have DFU with and without PAD. The secondary objective is to explore potential clinical efficacy by assessing changes in vascular parameters such as Ankle-Brachial Index and Toe-Brachial Index (ABI and/or TBI), Transcutaneous oxygen measurements (TcPO2).