View clinical trials related to Diabetic Foot Ulcer.
Filter by:Determining whether the utilization of Noraxon myoRESEARCH Software gait analysis Evaluation and orthotic gait Correction can reduce diabetic foot ulceration Or subsequent amputation in patients with a history of a diabetic foot ulceration.
Lower extremity complications such as chronic diabetic foot ulcers (DFUs) are a major risk for Type I/II diabetes patients. Minor injuries that would normally heal without consequence in non-diabetic individuals are at greater risk of bacterial infection and progression to non healing (chronic) wound status in diabetics, largely due to a loss of sensation in limbs (neuropathy) and decreased blood flow (vascular disease). If not treated efficiently and effectively, DFUs can have serious complications e.g. amputation, sepsis and death. The investigators propose to address this significant unmet clinical need using a novel commercial handheld fluorescence imaging product called the MolecuLight i:X (MolecuLight Inc.) which images clinically-significant wound bacteria without contrast agents or patient contact. Evidence in animal models of chronic wounds and multiple published clinical trials (mainly DFUs) have shown significant clinical potential for fluorescence imaging to detect potentially harmful bacteria in wounds otherwise invisible to doctors. The investigators have shown that clinicians can easily, objectively and more accurately determine the likelihood of bacterial infection than the standard of care. Moreover, published clinical evidence has shown fluorescence imaging enables more accurate microbial wound sampling and guides more targeted debridement of wounds to reduce bacteria levels. Our pilot data also show that when used like this, the i:X device accelerates DFU wound healing, compared with current methods. Thus, the investigators propose to expand the current pilot studies through a statistically-powered 3 y randomized controlled trial to test the therapeutic benefit of fluorescence-guided treatment for DFUs in a larger group of patients. A successful trial could help reduce DFU healing times compared with standard practice (using a new Canadian product) and improve patient quality of life, reduce amputation risk and alleviate health care costs for diabetes complications in Canada and beyond.
1. Aim Patients with diabetes, hammer, mallet and claw toes and ulcers associated with the named deformities will be randomized to tenotomy (cutting) of flexor tendons to the afflicted toes, done by needle and standard offloading or offloading alone. The effects of the surgery on time to healing of ulcers associated with the named deformities, recurrence of the ulcers, and rate of complications associated with the surgery. In addition to this all patients gait and balance will be examined before start of the study, and after 3 months, to se if there is an effect of the surgery on patients gait and balance. 2. Method A prospective randomized clinical study, which means a study were patients will be allocated randomly to surgery and standard care or standard care alone. Patients will attend a total of up to 14 visits over a 12-month period. 3.
Some people with diabetes get foot ulcers that do not heal. These ulcers can get infected and cause other medical problems. Five patients with these foot ulcers volunteered to participate in the first part of this study (C9T12015, NCT02657876). They are called Cohort 1 in this registration. Cohort 1 received one application (piece) of an experimental skin tissue to make sure it was safe. This study will extend the safety test of the experimental skin tissue. It will find out if it is safe to use more than once to cover non-healing ulcers. This extension will include two more groups, Cohort 2 and Cohort 3. Cohort 2 may get up to 5 applications. Cohort 3 may get up to 10 applications. The number of applications will depend on how well the wound is healing. Participants will be in the study up to one year.
The purpose of this clinical evaluation is to collect patient outcome data on a commercially available 510K FDA-approved product that is derived from minimal processing of Atlantic cod fish skin: KerecisTM Omega3 Wound. In this trial, two groups of UT grade IA/1C diabetic foot ulcers (DFUs), full skin thickness or extending through the subcutaneous or fat layers but not into tendon, muscle, or bone will receive standard of care (SOC) treatment for their condition. Patients will be randomized to SOC treatment and a 510k FDA-approved collagen alginate dressing (Fibracol Plus) or SOC and KerecisTM Omega3 Wound. The primary endpoint is the percentage of index ulcers (the ulcers being treated in the study) healed at 12 weeks in which two groups that will be compared are SOC with Fibracol Plus or SOC with KerecisTM Omega3 Wound
This study is a prospective, interventional, non-randomized study designed to assess the safety and efficacy of the Noxsano Bandage (study device) in healthy subjects and wound care subjects with a diabetic lower extremity ulceration and/or arterial insufficiency lower extremity ulceration.
Previous researches hipothesize that imposed limb-length discrepancies may discourage adherence in patients with active diabetic foot ulcer and using offloading devices. Our hipothesis is that the use of an external shoe lift contralaterally to the affected foot may improve adherence to offloading devices and improve healing.
Study Objective: The objective of this Phase 1 open-label study is to establish the safety and tolerability of Corlicyte mesenchymal stem cells (MSCs) in the treatment of patients with chronic diabetic foot ulcers (DFUs).
Diabetic foot ulcer (DFU) is a common complication of diabetes with global prevalence of 6.3%. Treatment of diabetic foot ulcer (DFU) is challenging with disappointing outcome. Wound debridement, infection control, pressure relief and revascularization are main pillars of DFU management. Various substances and modalities are being investigated for their potential effects in treating DFU, one of which is LL-37. In this randomized, controlled trial, 40 patients with uncomplicated DFU will be enrolled. Patients are randomly assigned to undergo twice a week treatment with 0.5 mg/mL LL-37 cream (treatment group) or placebo cream (control group) for 4 weeks in addition to standard wound care. The primary outcomes are the healing rate measured by wound area and granulation index and changes in patterns of aerobic bacteria colonization during the 4-week study duration and changes in concentrations of IL-α and TNF-α from fluid collected from DFU on the end of the second and third week of study compared to baseline.
Role of Negative Pressure Wound Therapy in the Management of Diabetic Foot Ulcers • The aim of this study will be to assess negative pressure wound therapy in treating diabetic foot ulcers.