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Foot Ulcer clinical trials

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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: NCT06309082 Not yet recruiting - Diabetes Mellitus Clinical Trials

Assessing Diabetic Foot Ulcer Microcirculation With High-frequency Contrast Enhanced Ultrasound

Start date: July 2024
Phase:
Study type: Observational [Patient Registry]

The objective of this observational study is to investigate and validate the utility of high-frame-rate ultrasound imaging technology for dynamic observation of the blood perfusion process at the site of ulcer wounds in real-time, focusing on patients with Diabetic Foot Ulcers (DFU). The primary research questions it seeks to address are as follows: - What are the dynamic characteristics of vascular dynamics at the site of ulcer wounds in patients with DFU under high-frame-rate ultrasound imaging? - Is High-Frequency Contrast-Enhanced Ultrasound (H-CEUS) technology feasible for effectively visualizing the microcirculation of ulcer wounds in patients with DFU? Participants will Undergo high-frame-rate ultrasound imaging for real-time observation of blood perfusion dynamics at the site of ulcer wounds. Researchers will compare ulcerated sites with normal sites to see whether the use of High-Frequency Contrast-Enhanced Ultrasound (H-CEUS) has any discernible impact on the visualization of microcirculation in ulcer wounds.

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: September 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 to 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: NCT06262854 Not yet recruiting - Clinical trials for Surgical Procedure, Unspecified

Efficacy and Safety of Stimulan® for the Treatment of Diabetic Foot Osteomyelitis. The BIG D-FOOT Study

BIG D-FOOT
Start date: March 1, 2024
Phase: N/A
Study type: Interventional

This study is designed as a double-blind, placebo-controlled, parallel series randomized trial aimed at verifying the effiicacy and safety of a local calcium-sulphate bio-absorbable antibiotic delivery (tobramicina+vancomicina) versus placebo (calcium-sulphate matrix without antibiotics) in patients with diabetic foot osteomyelitis treated with surgical procedures.

NCT ID: NCT06255288 Recruiting - Venous Leg Ulcer Clinical Trials

Time to Heal (Wound, Healing, Dialogue, Nutrition)

SNAK
Start date: January 23, 2024
Phase: N/A
Study type: Interventional

The objective of this study is to examine the feasibility, acceptability, fidelity, and outcome of a nurse-led nutritional intervention for patients with leg ulcers in a outpatient clinics. The intervention consists of a structured dialogue and patient information on key lifestyle behaviours to improve wound healing. Furthermore, the intervention includes protein supplement.

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.