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Diabetic Foot Ulcer clinical trials

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NCT ID: NCT06319287 Recruiting - Diabetic Foot Ulcer Clinical Trials

A Phase 2a Multi-Center, Prospective, Randomized Controlled Study to Evaluate the Safety and Efficacy of Topically Applied PEP-TISSEEL in Subjects With Diabetic Foot Ulcers (DFU)

Start date: February 27, 2024
Phase: Phase 2
Study type: Interventional

A Phase 2a Multi-Center, Prospective, Randomized, Controlled Study to Evaluate the Safety and Efficacy of Topically Applied PEP-TISSEEL in Subjects with Diabetic Foot Ulcers (DFU)

NCT ID: NCT06316115 Recruiting - Diabetic Foot Ulcer Clinical Trials

Effect On Paın And Anxıety Of Stress Ball Use Durıng Sharp Debrıdement

Start date: December 12, 2023
Phase: N/A
Study type: Interventional

Diabetic foot ulcer; It is a disease used to describe a series of lower extremity complications that may occur together with infection, ulceration or gangrene in individuals with diabetes and is coded as S91.3 and S91.8 in the International Classification of Diseases (ICD). Sharp debridement, one of the treatments for diabetic foot ulcers, is a short-term application performed with a sharp scalpel or scissors at the patient's bed or in outpatient clinic conditions. It should be performed by a skilled clinician with wound training. To our knowledge, no study has been found in the literature regarding the use of a stress ball as an intervention to prevent pain and anxiety during sharp debridement. In line with this information, this study will examine the effect of stress ball use on the pain and anxiety levels of patients with diabetic foot ulcers during wound debridement.

NCT ID: NCT06312579 Not yet recruiting - Diabetic Foot Ulcer Clinical Trials

At-Home Exercise Study for Veterans With Healed Diabetic Foot Ulcers

Start date: October 1, 2024
Phase: Phase 2
Study type: Interventional

Foot ulcers and amputations are a common and feared complication for people with diabetes. People with a diabetic foot ulcer have a higher risk of dying within five years than people with diabetes without an ulcer. At least one in four people with a new diabetic foot ulcer will die within five years, largely due to cardiovascular causes. The reasons for this increased mortality involve decreased mobility. People with a recently healed diabetic foot ulcer are considered "in remission" as opposed to "cured" because the underlying medical problems which led to their ulcer are still present. Once in remission, the current standard of care is to slowly increase ambulation. The problem is that people rarely return to the recommended level of mobility. The ability to safely maintain mobility with aging is critical. This pilot study is a small clinical trial to test the feasibility and acceptability of a home-based exercise regimen. The investigators will also assess if this home-based exercise regimen can increase mobility and function without increasing diabetic foot ulcer recurrence by improving lower extremity strength, lower extremity tissue perfusion and glycemic control.

NCT ID: NCT06292026 Active, not recruiting - Diabetic Foot Ulcer Clinical Trials

Efficacy of ProgenaMatrix™ in the Management of DFUs

Start date: March 14, 2022
Phase: N/A
Study type: Interventional

This multicenter study will collect data to determine closure time for diabetic ulcers when following protocol parameters and treatment with ProgenaMatrix™.

NCT ID: NCT06278935 Not yet recruiting - Diabetic Foot Ulcer Clinical Trials

Lifestyle Tailored Offloading for Diabetic Foot Ulcers

Start date: April 2024
Phase: N/A
Study type: Interventional

The goal of this pilot clinical trial is to develop and test a tailored occupational therapist-led lifestyle-focused intervention to aid patients in improving diabetic foot ulcer care. The main questions it aims to answer are: - Determine the acceptability and feasibility of taking a tailored lifestyle-focused approach as part of comprehensive diabetic foot ulcer management. Patient participants with DFUs who require offloading treatment will receive the tailored lifestyle-focused self-management intervention.

NCT ID: NCT06236750 Recruiting - Diabetic Foot Ulcer Clinical Trials

Post-Marketing Surveillance of Dehydrated Human Amnion/Chorion Membrane (DHACM) in Non-Ischemic Chronic Wounds

Start date: August 4, 2023
Phase: N/A
Study type: Interventional

The purpose of this survey is to observe the efficacy and safety of EPIFIX® dehydrated human amnion/chorion membrane (DHACM) for the treatment of intractable diabetic foot ulcers or venous leg ulcers.

NCT ID: NCT06231771 Not yet recruiting - Diabetic Foot Ulcer Clinical Trials

Safety and Efficacy of Stem Cells for Diabetic Foot Ulcer

Start date: May 2024
Phase: Phase 1/Phase 2
Study type: Interventional

The objective of this clinical trial is to evaluate the effectiveness and safety of Wharton-Jelly mesenchymal stem cells administered around the ulcer site in patients with nonhealing diabetic foot ulcers. The key inquiries it seeks to address include the percentage of patients achieving complete healing/closure of the specified ulcer at any point during the 6-week period, the duration required for the complete closure of the target ulcer, and the nature and occurrence of adverse events (AEs), along with the total number of AEs and the proportion of patients experiencing AEs. Patients meeting the eligibility criteria will receive either allogeneic mesenchymal stromal cells (MSC) or a placebo. The peri-ulcer injection of umbilical cord MSC or placebo will be administered at multiple locations, around the ulcer. Subsequent follow-up after the administration of umbilical cord MSC or placebo will be conducted to monitor and observe the progress of ulcer healing.

NCT ID: NCT06227520 Not yet recruiting - Diabetic Foot Ulcer Clinical Trials

Acellular Dermal Allograft for Chronic Diabetic Wounds

Start date: April 1, 2024
Phase: N/A
Study type: Interventional

The purpose of this study is to determine the efficacy of a novel decellularized dermal matrix (DDM) DermGEN™ for the treatment of diabetic foot ulcers (DFU). Despite several advances in wound treatments, hard-to-heal wounds, such as diabetic foot ulcer, still require 12 to 16 weeks to achieve complete closure. Although the focus of most research into wound-healing treatments has been on moisture and bacterial control, new approaches that target the instability of the extracellular matrix (ECM) in a wound are timely and much needed, particularly for hard-to-heal wounds such as DFUs. Innovative technologies that provide ECM interactions halt the chronic inflammatory cycle and stimulate cells that allow for tissue regeneration and wound healing. DermGEN™ is a human dermal allograft that has been minimally processed from human skin to remove epidermal and dermal cells while preserving the structure and intrinsic properties of the natural extracellular matrix of the dermis. This has potential to facilitate a shorter wound-healing time.

NCT ID: NCT06213337 Active, not recruiting - Diabetic Foot Ulcer Clinical Trials

Virtual Classroom Training and SMS Supported Interventions Improving Foot Care and Self-Efficacy

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

The type of this research is a randomized controlled experimental study. The aim of the research is to determine the effectiveness of virtual classroom training and SMS support in improving foot care behaviour and foot care self-efficacy in diabetic patients. The basic questions the research aims to answer are: - Is virtual classroom training effective in improving foot care behaviour and foot care self-efficacy in diabetic patients? - Are SMS-supported interventions effective in improving foot care behaviour and foot care self-efficacy in diabetic patients? Within the scope of the research, participants are expected to attend virtual classroom training and read the SMS sentences sent. In order to examine the effects of virtual classroom training and SMS-supported interventions, researchers created a control group, a virtual classroom, an SMS support group, and an SMS-supported virtual classroom group.

NCT ID: NCT06185465 Recruiting - Burns Clinical Trials

Effectiveness and Safety of Using Prontosan to Treat Bacterial Biofilm

Start date: January 3, 2024
Phase: N/A
Study type: Interventional

The goal of this prospective, multi-center, randomized, parallel-controlled, open-label clinical study is to evaluate the effectiveness and safety of Prontosan wound irrigation solution comparing with Normal Saline on the removal of wound bacterial biofilm through observing the morphological characteristics and development of bacterial biofilm in chronic wound patients with secondary infections. The main questions it aims to answer are: - Difference in scoring the positive rate of bacterial biofilm before the first treatment and on the 7th day of treatment in Group A and Group B - Difference in scoring the positive rate of bacterial biofilm before the first treatment and on the 3rd day of treatment in Group A and Group B . - Positive detection rate of bacterial biofilm in group and group B before the first treatment, and on the 3rd and 7th day of treatment, and difference of the positive detection rate of biofilm among the two groups. - 4-phase typing of bacterial biofilm detected in Group A, Group B and Group C before the first treatment, and on the 3rd and 7th day of treatment, and the proportion difference of 4-phase typing of biofilm among the two groups. - Wound healing rate - Skin Infection Rating Scale (SIRS) score. - Distribution of inflammatory cells on the wound. - Detection rate of bacteria/drug-resistant bacteria on the wound and their correlation with the detection rate of bacterial biofilm. Participants will be randomized to experimental group or Control group, Prontosan Wound Irrigation Solution or normal saline will be extracted with syringe (Dosage 1-2ml/cm2), and the wound is rinsed 1 cm from the wound. Then, Prontosan wound irrigation solution or normal saline is used to saturate the gauze, and the gauze is applied to the wound for 15 minutes. After removing the gauze, cover it with oil gauze, then cover it with 8 layers of gauze and wrap it with a bandage.