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Diabetic Foot clinical trials

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NCT ID: NCT05581966 Not yet recruiting - Diabetes Clinical Trials

Wound Assessment Using Spectral Imaging EU/UK

WAUSI EU/UK
Start date: March 15, 2023
Phase:
Study type: Observational

During the observational, non-interventional study, at Baseline Study Visit (BSV) subjects will be screened and consented. Eligible subjects will undergo imaging with the DeepView device. Pre- and post-debridement images will be obtained (if debridement performed per SOC), as well as reviewing medical history and physical assessments. Additional Study Visits (SVs) will be performed when patient returns to the clinic for Routine Clinic Visit for up to 12 weeks or wound closure. During these visits DeepView imaging will occur pre- and post-debridement, and the status of the subject's treatment will be recorded.

NCT ID: NCT05483777 Not yet recruiting - Diabetic Foot Clinical Trials

Application of Platelet-Rich Fibrin on Diabetic Foot Wound

Start date: February 15, 2023
Phase: N/A
Study type: Interventional

This study was planned as a prospective case-control study to examine the effect of PRF application on wound healing in diabetic foot wound. The sample of the study will consist of patients with diabetic foot wounds, who met the inclusion criteria and agreed to participate in the study. It is planned to include 7 patients for the experimental group and 7 patients for the control group (14 patients in total). If the patient is in the experimental group, PRF will be applied to the diabetic foot wound, and in the control group, classic wound dressing (CWD) will be applied.

NCT ID: NCT05446337 Not yet recruiting - Diabetes Clinical Trials

Diabetic Foot Care and Limb Preservation Pathway: Developmental Evaluation Study

Start date: July 15, 2022
Phase:
Study type: Observational

University Health Network (UHN), working together with local primary care practitioners, patients, and community healthcare services is developing a Diabetic Foot Care and Limb Preservation Care pathway. Our goal is to improve foot care for individuals living with diabetes. This study is using a method called developmental evaluation to help map out the system and to provide information in real-time so that the pathway can be adapted and respond to what is learned. The investigators are going to explore different factors (facilitators and barriers) and processes, which help or hinder the development, implementation, and adoption of the pathway. The investigators are also going to find out about the patient and provider's experiences with diabetic foot care, wound care, limb preservation, and amputation. Finally, the study team is going to look at value-based health care for the diabetic foot care pathways and document healthcare resource utilization, costs, and outcomes. The study team will conduct interviews of stakeholders, including patient representatives, and will examine the participation and engagement in the pathway, identifying barriers and facilitators of the process. Once the pathway has started, the study team will look at the way the care is delivered and satisfaction through surveys to patients and practitioners. The study team will also ask about patients' quality of life and their ability to manage diabetes. The study will aim to answer three key questions: What is happening? Why is it happening? and, What are reasonable prospects, and tools for change? The entire study is anticipated to take 3 years to complete.

NCT ID: NCT05444842 Not yet recruiting - Diabetes Mellitus Clinical Trials

Insulin Iontophoresis Mixed With Oleic Acid Versus Topical Insulin in Patients With Chronic Diabetic Foot Ulcer

Start date: July 5, 2022
Phase: N/A
Study type: Interventional

This study will be conducted to investigate the effect of Insulin iontophoresis mixed with oleic acid versus topical insulin in patients with chronic diabetic foot ulcer

NCT ID: NCT05431660 Not yet recruiting - Diabetic Foot Clinical Trials

Diabetic Foot School and Biomechanics

Start date: September 1, 2022
Phase: N/A
Study type: Interventional

The primary aim of the study is to establish a diabetic foot school. The secondary aim is to compare the effects of the training given to diabetic foot patients within the scope of the diabetic foot school, on sensory, balance, lower extremity biomechanics and the effectiveness of these individuals on the knowledge level of diabetic foot. With the evaluations to be made, the effectiveness of the diabetic foot school program will be proven and it will contribute to the literature with objective and evidence-based results. For these reasons, the hypotheses on which the research is based were formed as follows; H11 hypothesis: The diabetic foot school program applied in diabetic foot patients has an effect on foot biomechanical measurements and gait parameters. Hypothesis H12: In diabetic foot patients, the diabetic foot school program has an effect on the sensation of individuals. H13 hypothesis: In diabetic foot patients, the diabetic foot school program has an effect on the balance of individuals. H14 hypothesis: In diabetic foot patients, the diabetic foot school program has an effect on the diabetic foot and self-care behaviors of individuals.

NCT ID: NCT05415878 Not yet recruiting - Diabetes Mellitus Clinical Trials

Impact of Removable Cast Walker Design on Usability for Patients With Diabetic Foot Ulcers

Start date: October 1, 2022
Phase: N/A
Study type: Interventional

Within their lifetime, over 30% of people living with diabetes will develop a diabetic foot ulcer (DFU), many of which will never heal and may require amputation. Removable cast walkers (RCWs) are commonly prescribed to offload (treat) DFUs. While RCWs are prescribed to be worn during all weight bearing activities, adherence to this prescription is low. This is a serious concern given that low adherence predicts poor DFU healing. This study will provide pilot/feasibility data to inform a larger clinical trial to evaluate the impact of existing RCW designs on adherence and DFU healing. We will also quantify the effect of RCW form on biomechanical and self-reported measures related to usability. Our working hypothesis is that healing outcomes with a given RCW will be predicted by biomechanical and self-reported measures of RCW usability, with the predictive relationship partly explained by the effect of these measures on adherence.

NCT ID: NCT05383391 Not yet recruiting - Diabetic Foot Clinical Trials

Diabetic Foot Self Care

Start date: June 1, 2022
Phase:
Study type: Observational

Aim of the study: Studying patients' knowledge, practice and barriers of foot self-care among diabetic patients attending Sohag University Hospital,. Objectives: 1. To determine patients' knowledge and practice of foot self-care among diabetic patients attending Sohag University Hospital. 2. To detect barriers of diabetic foot self-care among diabetic patients attending Sohag University Hospital. Patients and methods: Place of the study (locality): Sohag University Hospital at endocrine outpatient clinic . Type of the study (Study design): A cross-sectional, descriptive questionnaire based study was designed to evaluate knowledge and practice of diabetic patients regarding foot care. Period of data collection . 6 months Questionnaires will be distributed among the diabetes mellitus patients in Sohag University Hospital to get the information about the knowledge of the disease among patients. The answer of the questions will be scored with "yes" "no" or I don't "know". The questionnaire consists of four sections(8): 1. Demographic section . 2. Knowledge related questions regarding foot care . 3. Practice related questions regarding practice of foot care . 4. Barriers to foot self-care . Questionnaire contained 7 questions regarding knowledge of foot care and 12 questions regarding practice of foot care, which was approved and validated by the research committee of faculty of Pharmacy.

NCT ID: NCT05368142 Not yet recruiting - Diabetic Foot Ulcer Clinical Trials

Nocardia Cell Wall Skeleton for the Treatment of Diabetic Foot Ulcer Wounds

Start date: May 20, 2022
Phase: Phase 4
Study type: Interventional

This study was to investigate the efficacy and safety of Nocardia rubra Cell Wall Skeleton (NCWS) in the treatment of diabetic foot ulcer wounds. The study was a prospective, randomized, controlled, multicentre study . The subjects were randomly divided into two groups: NCWS group and control group(silver ions dressing), with a total of 116 cases and 58 cases in each group. Patients in the NCWS group received nocardia rubra cell wall skeleton for external use, in parallel with silver ions dressing treatment. The efficacy and side effects were observed, with a primary endpoint of 30-days wound healing rate.

NCT ID: NCT05251480 Not yet recruiting - Diabetes Mellitus Clinical Trials

Examining the Effectiveness of DermGEN™ in the Treatment of Diabetic Foot Ulcers in First Nations People

Start date: December 30, 2022
Phase: N/A
Study type: Interventional

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.

NCT ID: NCT05198544 Not yet recruiting - Diabetic Foot Clinical Trials

Clinical Trial Evaluating a Hyaluronic Acid Matrix in the Treatment of Chronic Non-healing Diabetic Foot Ulcers (DFUs)

Start date: June 1, 2023
Phase: N/A
Study type: Interventional

This study is a multi-center, prospective trial designed to evaluate the use of HaM in Wagner grade 1 and 2 DFUs. After screening, subjects are treated with weekly application of HaM and SOC for 8 weeks followed by SOC alone for the remainder of the 12-week trial period. The standard of care in this study consists of offloading of the DFU using a total contact cast or fixed ankle walker, sharp debridement, infection management with the use of antiseptics and proper moisture balance.