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Foot Ulcer clinical trials

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NCT ID: NCT04450693 Recruiting - Clinical trials for Diabetic Foot Infection

Cryopreserved Human Umbilical Cord (TTAX01) for Late Stage, Complex Non-healing Diabetic Foot Ulcers (AMBULATE DFU II)

Start date: November 20, 2020
Phase: Phase 3
Study type: Interventional

It is hypothesized that application at 4-week or greater intervals of the human placental umbilical cord tissue TTAX01 to the surface of a well debrided, complex diabetic foot ulcer (DFU) will, with concomitant management of infection, result in a higher rate of wounds showing complete healing within 25 weeks of initiating therapy, compared with standard care alone. This second confirmatory Phase 3 study examines a population of diabetic foot ulcer patients having adequate perfusion, with or without neuropathy, and a high suspicion of associated osteomyelitis in a complex, high grade wound.

NCT ID: NCT04328181 Recruiting - Clinical trials for Coronary Artery Disease

Comparison of Imaging Quality Between Spectral Photon Counting Computed Tomography (SPCCT) and Dual Energy Computed Tomography (DECT)

SPEQUA
Start date: January 29, 2021
Phase: N/A
Study type: Interventional

This pilot study wants to determine to which extent SPCCT allows obtaining images with improved quality and diagnostic confidence when compared to standard Dual Energy CT (DECT), both with and without contrast agent injection. Depending on the anatomical structures/organs to be visualized during CT examinations, different scanning protocols are performed with quite variable ionizing radiation doses. Therefore, in order to obtain the most extensive and representative results of the improvement in image quality between SPCCT and DECT that will be performed CT imaging on several body regions and structures, including diabetic foot, diabetic calcium coronary scoring, adrenal glands, coronary arteries, lung parenchyma, kidney stones, inner ear, brain and joints, earl/temporal bone, colorectal carcinosis.

NCT ID: NCT04323462 Recruiting - Diabetic Foot Ulcer Clinical Trials

Intensive Glycemic Control For Diabetic Foot Ulcer Healing

INGLOBE
Start date: October 1, 2021
Phase: Phase 4
Study type: Interventional

With the available molecular and cellular evidence of impaired wound healing due to hyperglycemia, investigators postulate hypothesis asking whether intensive glycemic control could improve diabetic foot ulcer healing rates. A study showed improvement in phagocytic activity of macrophages after 5 days of intensive glycemic improvement in 21 patients of diabetes. Another retrospective cohort study studied the effect on HbA1c as predictor of healing rate in DFU. Latter found significant association of HbA1c with wound area healing rate. However a recent systematic review failed to find any randomized control trial comparing the effect of intensive versus conventional glycemic control for treating DFU. Hence, investigators want to explore the hypothesis by conducting a randomized control trial with the primary aim of wound healing in patients of diabetic foot ulcer in response to intensive glycemic control in comparison to conventional glycemic management.

NCT ID: NCT04315909 Recruiting - Clinical trials for Diabetic Foot Ulcers

The Effect of Platelet-Rich Plasma-Fibrin Glue in Combination With Vitamin E and C for Treatment of Non-healing Diabetic Foot Ulcers

Start date: August 28, 2019
Phase: Phase 2/Phase 3
Study type: Interventional

The aim of this study is to evaluates the chance of non-healing Diabetic Foot Ulcers repair by reducing oxidative stress caused by diabetes by taking vitamin E and C supplements along with the use of Platelet-Rich Plasma-Fibrin Glue as an effective treatment for wound healing.

NCT ID: NCT04310137 Recruiting - Diabetic Foot Ulcer Clinical Trials

Self-directed Versus Therapist-directed Re-loading on Incidence of Ulcer Recurrence

Start date: May 1, 2021
Phase: N/A
Study type: Interventional

This study is designed to evaluate if how people are told to return to walking after a skin injury affects whether or not they develop new (recurrence) skin breakdown on their feet. The people in this study will have diabetes and have a recently closed foot ulcer. About half will be specifically told how to return to walking and the other half will be told to return to walking slowly. How people naturally return to walking will also be established.

NCT ID: NCT04280016 Recruiting - Diabetic Foot Ulcer Clinical Trials

The Effect of Exercise on Wound Healing While Off-loading

Start date: May 14, 2021
Phase: N/A
Study type: Interventional

This study seeks to establish the effect of adding exercise to off-loading interventions on the healing time for people with diabetes mellitus and a foot ulcer. Hypothesis: Consistent with the literature, results are expected to resemble the accelerated healing seen when older adults exercised in the presence of wounds.

NCT ID: NCT04232631 Recruiting - Diabetic Foot Ulcer Clinical Trials

Non-Invasive Testing to Evaluate Wound Healing in Diabetes

Start date: April 28, 2021
Phase:
Study type: Observational

Data will be collected with 3 vascular imaging devices (IntraOx Vioptix, Newark, CA; Hyperview, HyperMed Imaging, Memphis, TN; Snapshot NIH, Kent Imaging, Calgary, Alberta, Canada). The wound will be imaged with the 3 devices at index research encounter (this will count as the initial pre-operative imaging if the patient requires surgery), before surgery for interval or additional surgeries, during surgery, and during clinic follow-up (one set of imaging approximately every 3-5 weeks) visits for a maximum follow up time of 12 months or until the wound is documented as healed, whichever occurs first. The investigators will collect data from the medial and lateral angiosomes on the dorsum and plantar aspects of the foot and the anterior and posterior leg. Subject data will be obtained from the patient by oral history and physical exam and the medical records of patients of the investigators: vascular data, demographic medical history, wound characteristics and measurements, frequency of debridement and off-loading. Collection of lab data will be obtained such as cultures glycosylated hemoglobin, hemoglobin and hematocrit, ESR, CRP and eGFR obtained per standard of care. Imaging with the three devices is research-only and is not standard of care.

NCT ID: NCT04210089 Recruiting - Diabetes Mellitus Clinical Trials

Total Contact Soft Cast in Diabetic Foot Ulcers

Start date: October 13, 2020
Phase: N/A
Study type: Interventional

To determine the effectiveness, compliance, patient tolerance, ease of use and safety of total contact soft cast in diabetic foot ulcers.

NCT ID: NCT04207099 Recruiting - Clinical trials for Non Healing Diabetic Foot Ulcer

Comparing Wound Area Reduction of Non-healing DFUs Using MolecuLight i:X Versus Standard of Care

WAR
Start date: February 14, 2020
Phase:
Study type: Observational

This is a 12 week, randomized controlled trial. There are 2 arms and 20 patients with non healing diabetic foot ulcer allocated in each arm. One arm receives i:X guided treatment and the other arm receives standard of care treatment. Our primary objective is to compare the wound area reduction in both arms.

NCT ID: NCT04198441 Recruiting - Diabetic Foot Ulcer Clinical Trials

The Omeza Protocol for Chronic Ulcers

Start date: June 2, 2020
Phase: N/A
Study type: Interventional

This study will compare the Omeza® Products Bundle to standard of care (SOC) for in subjects with chronic venous leg ulcers and subjects with diabetic foot ulcers.