View clinical trials related to Diabetic Foot.
Filter by:The Biorepository will guide the Diabetic Foot Consortium (DFC) activities for collection and storing biosamples and data from participants enrolled in other current and future DFC research studies.
The main purpose of this exploratory clinical investigation is to study the binding of bacteria and fungi from hard-to-heal wounds to the DACC-coated dressings.
In this study, a novel placental membrane product Matrion™ (LifeNet Health, Inc., Virginia Beach, VA) will be used as a treatment for subjects with diabetic foot ulcers. Matrion is composed of placental membrane derived from donated human birth tissue containing both the innermost amniotic layer and the outermost chorionic layer, inclusive of the trophoblast layer. Matrion is minimally processed and disinfected using a proprietary decellularization technology and terminally sterilized that safely renders the placental membrane acellular and sterile for its intended surgical applications.
Diabetic foot ulcers (DFUs) are a frequent clinical problem observed in diabetic patients. Properly managed, most can be cured, but many patients needlessly undergo amputations because of improper diagnostic and therapeutic approaches. The purpose of this study is to evaluate the effectiveness of a compounded, anti-infective irrigation therapy to increase the healing rates of diabetic foot ulcers and thereby provide a new therapeutic option for health care providers treating high-risk patients with DFUs regardless if secondary fungal infections are present. Participants diagnosed with diabetes type 1 or 2 and with a documented open diabetic foot ulcer/wound with or without a secondary fungal infection will be included in this prospective, active intervention pilot study. Healing rates will be evaluated every two weeks following the initiation of study therapy up to three months. Participants with diabetic foot ulcers will be treated with a compounded, anti-infective irrigation therapy daily until closure of the ulcer or up to a maximum of 3 months. Participants will be asked to return to clinic every two - four weeks for assessment of the ulcer and compliance with treatment. A sample size of approximately 100 patients is estimated to have 90% power to detect 15% improvement in ulcer healing rates to 45% and 35% compared to historical benchmarks of approximately 30% for ulcers of <6 months duration and 20% for ulcers ≥6 months duration and/or prior treatment failure, respectively.
The aim of this clinical study is to compare the efficacy and tolerance of 3 versus 6 weeks of antibiotherapy in patients with diabetic foot osteomyelitis treated medically.
Diabetic foot ulcers (DFU) are one of the complications of diabetes mellitus resulting from multiple causes such as neuropathy, ischemia, and infection that contribute to morbidity and amputation. The prevalence of DFU has been estimated to be 3 to 5 times higher than the overall population. Minor amputations (digital or transmetatarsal) are the treatment of choice in case of irreversible DFU. However, many minor amputations do not heal and require re-amputation. Improvements of healing rate after adipose stem cells (ASCs) injection through micro-fragmented autologous adipose tissue of the amputation stump following minor DFU amputation were demonstrated. The use of ASCs obtained from the superficial enhanced fluid fat injection technique (SEFFICARE) to improve the healing process after DFUs minor amputation is the object of the present study. A single-center non-randomized prospective observational study will be performed. The recruited patients will undergo local injection of superficial enhanced fluid fat after a lower limb minor amputation. Laboratory analysis to evaluate the composition of the tissue and stromal cell components harvested from adipose tissue with SEFFICARE system by using digital droplets PCR. These data will serve for making associations between the clinical outcome and characteristics of the cell population administered to each patient.
Diabetic foot ulcers (DFU) are aggressive complications of diabetes mellitus (DM) and affect 25% of these patients. DFU are associated with a high risk of amputations and early mortality and significantly impact quality of life (QoL). The low-level laser therapy (LLLT) is an important approach for the treatment of DFU, however there is a lack of data on its influence on the QoL of patients with DFU. On the other hand, adherence to self-care is a factor closely related to QoL. Therefore, this study is justified by the need to understand the impact of LLLT on QoL and its relationship with self-care. Aim: To evaluate the quality of life of patients with diabetic foot ulcers treated with different doses of LLLT (GaAs) 904 nm and its association with aspects of adherence to self-care. Methods: This is a randomized, double-blind, placebo-controlled clinical trial. Participants will be randomly assigned to the groups: control LLLT placebo (CG), LLLT 904 nm 10 J/cm² (LG1), LLLT 904 nm 8 J/cm² (LG2) and LLLT 904 nm 4 J/cm² (LG3). QoL data, percentage of healing and pain will be assessed before the start of the intervention, in 10th week and after one month to the end of intervention, self-care will be assessed before the start of the intervention and at the end of intervention. Eighty participants with DFU will be recruited who will receive intervention twice a week for up to 20 visits (10 weeks).
Phase IV, randomized, prospective, multi-center, open-label, comparison of transforming powder dressing to standard of care dressing for healing diabetic foot ulcers.
The overall objective of this project is to describe the prevalence of and risk factors to diabetic neuropathy in a representative cohort of diabetes patients and to investigate pathophysiological conditions in those patients with neuropathy. This project will yield substantial new knowledge about the prevalence of diabetic neuropathy in type 1 and type 2 DM persons, new risk factors to neuropathy and the association to other diabetic complications. Findings related to the study may facilitate new treatment regimens prompting a better neuropathy treatment with reduced incidence of diabetic complications. First patients at SDCC will be screened for diabetic neuropathy (Study 1.1) with an extended neuropathy screening program as an addition to the routine neuropathy screening at SDCC. 1000 patients with type 1 DM and 1000 patients with type 2 DM will be included. This screening study is a prerequisite for the further study of study participants in substudies investigating associations between diabetic neuropathy and diabetic complications as described below. Hypothesis: Several patients with diabetes have undiagnosed neuropathy and associated diabetic complications. We hypothesize that diabetic neuropathy is underdiagnosed at SDCC and can be diagnosed with targeted screening with new and traditional measuring techniques. In addition, several patients may have complications related to neuropathy, including foot complications, and dysregulation of glucose metabolism Aim: This study consists of a screening study (study 1.1) and two substudies (1.2 and 1.3 ). Study 1.1 is a cross-sectional study describing the prevalence of diabetic neuropathy based on questionnaire data and objective measures as described below and associated diabetic complications including foot complications. The primary aim is to explore the prevalence of diabatic neuropathy in patients with type 1 and type 2 DM at SDCC and secondarily to explore associations between diabetic neuropathy and complications, as described in the respective sections below. The substudy 1.2 is an observational single center cohort study with the aim of investigating associations between neuropathy diagnosed with new devices for measurement of neuropathy and foot complications in patients with type 1 and type 2 diabetes. The substudy 1.3 is an observational single center cohort study investigating the association between CAN and glycemic variability in patients with type 1 diabetes.
Topical Negative Pressure Wound Therapy (TNPW) is an established tool in the management of Diabetic foot ulcer in many countries. This treatment option is under utilized in the public sector of Mauritius. This study aims to determine the efficacy of TNPW through identification of biomarkers in the Mauritian setting compared with conventional treatment. Patient with DFU will be selected based on an eligible criteria and randomly assigned to intervention group or control group. Primary Objective: To determine the efficacy of TNPW in the public sector in Mauritius Secondary Objectives: To compare healing times, prognostic factors skin biopsies based on biomarker, histological and genomic analysis A randomised controlled study is being proposed, where up to 100 participants will be recruited. The wounds of participants in the intervention arm will be managed with 3 weeks of TNPW.