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Diabetic Foot clinical trials

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NCT ID: NCT06004219 Recruiting - Clinical trials for Diabetes Mellitus, Type 2

Peer Support for Patients With Diabetic Foot Ulcers

Start date: November 21, 2023
Phase: N/A
Study type: Interventional

The objective of the study is to develop a peer support program that helps improve ulcer care in patients with a diabetic foot ulcer (DFU).Diabetes, peripheral arterial disease (PAD), foot ulceration, and subsequent amputation are unevenly patterned in terms of racial/ethnicity, socioeconomic status, health insurance, and geographic area. The project will identify opportunities to reduce health disparities among economically marginalized patients regarding DFU outcomes.

NCT ID: NCT06003400 Recruiting - Diabetic Foot Ulcer Clinical Trials

Proof of Concept Open Label, Clinical Trial to Evaluate the Safety and Efficacy of the "FITT" Device in Diabetic Foot Ulcers Patients

TriO FITT
Start date: March 29, 2023
Phase: N/A
Study type: Interventional

The TriO FITT device is designed to improve the symptoms of chronic diabetic ulcers. The mechanism of action of the device optimizes and combines the administration known supproting treatments to chronic diabetic ulcers. The treatment is astimated to improve the wound conditions of acute and chronic diabetic wounds.

NCT ID: NCT05999656 Recruiting - Safety Clinical Trials

Human Cord Blood Mononuclear Cells in the Treatment of Refractory Diabetic Foot

Start date: May 28, 2023
Phase: N/A
Study type: Interventional

Refractory diabetic foot is one of the most serious and costly chronic complications of diabetes. It is the leading cause of nontraumatic lower-extremity amputations while the conventional treatment is not effective. Therefore, new therapeutic methods are urgently needed. Cell therapy has shown unique advantages and potential in tissue regeneration and wound repair, and is considered as a new effective method to treat diabetic foot. Meanwhile, human cord blood-derived mononuclear cells (HCB-MNCs) with its sufficient sources, strong ability of proliferation and differentiation, and weak immunogenicity, is suitable for the treatment of diabetic foot. It is a prospective, single-arm, single-center clinical study to investigate the efficacy and safety of local injection of HCB-MNCs in the treatment of refractory diabetic foot.

NCT ID: NCT05979584 Recruiting - Diabetic Foot Clinical Trials

Platelet Rich Plasma VS Platelet Fibrin Plasma in Treatment of Diabetes Related Wound:a Randomized Controlled Trial

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

The goal of this randomized control trial is to compare the efficacy and safety of Platelet Rich Plasma VS Platelet Fibrin Plasma in patients with diabetes foot ulcer. The main question it aims to answer are: - Whether the Platelet Fibrin Plasma have noninferior efficacy than Platelet Rich Plasma in treatment of diabetes foot ulcer? - Whether the Platelet Fibrin Plasma have noninferior safety than Platelet Rich Plasma in treatment of diabetes foot ulcer? Participants will be assigned with a 1:1 ratio into intervention group and control group. Participants of intervention group will receive Platelet Fibrin Plasma in addition with clinical optimal treatment plan after the wound bed preparation for closure. Participants of intervention group will receive Platelet Rich Plasma in addition with clinical optimal treatment plan after the wound bed preparation for closure.

NCT ID: NCT05974592 Recruiting - Diabetic Foot Clinical Trials

The Effect of Nurse-Led Diabetic Foot Self-Management Training Program

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

Diabetic foot is one of the most important chronic complications of Diabetes Mellitus (DM), which is a global health problem today. Diabetic foot not only affects the individual's quality of life, body image, role performance, and social and economic structure of the family and society but also creates a serious burden on the individual's family and health system. Therefore, some approaches that include foot and nail care, shoe and sock(s) selection, nutrition, and exercise practices are recommended to prevent diabetic foot and to increase functional capacity, without the need for surgical treatment. It is crucial to maintain these recommended approaches throughout the patient's life to ensure effective management of the diabetic foot. This study aims to determine the effect of the nurse-led diabetic foot self-management training program on diabetic foot knowledge, foot care behavior, and self-efficacy level in patients with type 2 DM. This study was planned in a randomized controlled design. The population of the study will consist of type 2 DM patients who do not use insulin therapy and who applied to University of Health Sciences Diskapi Yildirim Beyazit Training and Research Hospital Diabetes outpatient clinic and Diabetes Education outpatient clinic between September 2022 and September 2023. According to the power analysis, 38 participants are targeted to be reached in total. Data will be collected with a Personal Information Form, Diabetic Foot Information Scale, Foot Care Behavior Scale, Diabetic Foot Care Self-Efficacy Scale, and Diabetic Foot Evaluation Form. As a result of this study, it is expected that the nurse-led diabetic foot self-management training program will increase the diabetic foot knowledge, foot care behavior and self-efficacy levels of diabetic foot knowledge, foot care behavior, and self-efficacy level in patients with type 2 DM.

NCT ID: NCT05948592 Recruiting - Clinical trials for Diabetic Foot Infection

Bacteriophage Therapy TP-102 in Patients With Diabetic Foot Infection

REVERSE2
Start date: November 8, 2023
Phase: Phase 2
Study type: Interventional

TP-102 is a novel bacteriophage cocktail comprised of 5 (five) lytic bacteriophages against Staphylococcus aureus, Pseudomonas aeruginosa, and Acinetobacter baumannii. TP-102 is being developed for topical treatment of patients with wound infections including chronic ulcers; applied every other day (three times weekly (TIW)).

NCT ID: NCT05930210 Recruiting - Diabetes Mellitus Clinical Trials

A Study to Evaluate ENERGI-F703 GEL in Diabetic Foot Ulcer

Start date: May 30, 2023
Phase: Phase 3
Study type: Interventional

This Phase 3 study is a randomized, double-blind, vehicle-controlled, multiple-center, parallel study to evaluate efficacy and safety of ENERGI-F703 GEL compared with vehicle control in subjects with Wagner Grade 1 to Grade 2 diabetic foot ulcers. Baseline target ulcer size (<16 cm2 vs ≥16 cm2 ) will be included as a stratification factor. Subjects will be randomized 1:1 to receive ENERGI-F703 GEL or vehicle control using an interactive web response system for randomization to automatically assign a unique subject randomization number. Total duration of the study will be up to 31 weeks including Screening visit (approximately 2 to 3 weeks), double-blind dosing/observation phase (16 weeks), and a safety follow-up of 12 weeks after the last administration of study treatment.

NCT ID: NCT05928013 Recruiting - Diabetic Foot Clinical Trials

Neuropathy Evaluation Using the Vibration of a Mobile Phone

NERVE
Start date: April 19, 2023
Phase: N/A
Study type: Interventional

A single centre validation/method comparison study of the experimental NERVE device for the measurement of vibration perception threshold against the established 'Neurothesiometer' device, evaluating agreement and reliability. It will also include collecting feedback from patients, carers and clinicians on the usability of the device

NCT ID: NCT05855980 Recruiting - Diabetic Foot Clinical Trials

Toe Amputations in Patients With Diabetes

PANDORAT
Start date: May 22, 2023
Phase: N/A
Study type: Interventional

This study is a randomized controlled trial (RCT) to evaluate outcome after toe amputation due to diabetic foot infection. Aim of this RCT is to evaluate wound healing and functional outcome based, whether wound is closed or left open. As a part of this study, emerging technology of thermal imaging is evaluated as a possible tool to predict complication after amputation.

NCT ID: NCT05850611 Recruiting - Clinical trials for Diabetic Foot Ulcers

The Effect of Combination Therapy of Oral MB and PRP-FG in Patients With Non-healing Diabetic Foot Ulcer

Start date: April 30, 2023
Phase: Early Phase 1
Study type: Interventional

The aim of this study is to evaluate the chance of non-healing diabetic foot ulcers repair by improving the condition of lack of oxygen or hypoxia in the wound area caused by diabetes using methylene blue along with the use of platelet-rich plasma-fibrin glue as an effective treatment for wound healing.