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Diabetic Foot clinical trials

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NCT ID: NCT06353568 Not yet recruiting - Diabetic Foot Clinical Trials

Effect of Photobiomodulation as a Preventive Treatment for Diabetic Foot

Start date: May 30, 2024
Phase: N/A
Study type: Interventional

This study seeks to evaluate the effect of photobiomodulation (PBM) in the prevention of Diabetic foot (DF), in patients at moderate and high risk for its development, through a controlled, randomized, double-blind clinical trial. Individuals between 18 and 75 years old of both sexes, with type 2 diabetes mellitus (DM), and moderate and high risk for DF will be randomized and allocated into 2 groups of 32 participants each. The PBM Group will use a boot with 1344 LEDs, 504 of which are 660 nm located on the sides of the boot (28.5 milliwatt, 10 J per LED); 504 850 nm also located on the sides of the boot (23 milliwatt, 8 J per LED); 168 of 660 nm located at the base of the boot (28.5 milliwatt, 10 J per LED); 168 of 850 nm also located at the base of the boot (23 milliwatt, 8 J per LED) once a day for 6 minutes, for 60 days and will receive therapeutic education. Participants will be evaluated at baseline, after 30 days (clinical examination) and after 60 days (clinical examination, Peripheral Neuropathy (PN) assessment, Peripheral Artery Disease (PAD) assessment, blood and urine tests, and quality of life).

NCT ID: NCT06328010 Enrolling by invitation - Burns Clinical Trials

An Observational Clinical Registry to Collect Safety and Efficacy Data on Wound Care in Medical Centers

SIDDX
Start date: April 1, 2024
Phase:
Study type: Observational [Patient Registry]

Collect data on various wound treatments and their related wound healing process, in real life settings. Analyze the safety and efficacy of wound treatments, including: advanced biological/synthetic grafts and standard of wound care treatments.

NCT ID: NCT06319287 Recruiting - Diabetic Foot Ulcer Clinical Trials

Phase 2a Multi-Center Prospective, Randomized Trial to Evaluate the Safety & Efficacy of Topical PEP-TISSEEL for 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: 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: NCT06288555 Completed - Diabetic Foot Clinical Trials

Validation of Ipswich Touch Test for Diabetic Peripheral Neuropathy Screening in Primary Care

Start date: December 21, 2023
Phase:
Study type: Observational [Patient Registry]

The goal of this observational study is to assess the accuracy of screening for diabetic peripheral neuropathy by comparing the Ipswich touch test with the 10-g monofilament test in patients diagnosed with type 2 diabetes. The main question it aims to answer is: How does the accuracy of the Ipswich Touch Test for identifying peripheral neuropathy compare to the traditional 10-g monofilament test? Participants underwent both the Ipswich touch test and the 10-g monofilament test.

NCT ID: NCT06280053 Completed - Burn Wound Clinical Trials

HealiAid in the Treatment of Different Wounds

Start date: March 2, 2016
Phase: N/A
Study type: Interventional

The goal of this open-label, post-market clinical follow-up study is to demonstrate the safety and effectiveness of HealiAid Collagen Wound Dressing in patients classified into different types of wounds: venous ulcers, bedsores, diabetic foot wounds and burn wounds. The main questions it aims to answer are: 1. The wound healing which was defined as the percentage of area change. 2. The duration of wound healing. 3. The granulation tissue growth of the wound. 4. The wound exudate. 5. Safety Indicators of which incidences after treatment. HealiAid will be applied to eligible subjects who will later be followed up for 12 weeks.

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.