Active clinical trials for "Diabetic Foot"

Patients presenting to Johns Hopkins with a diabetic ulcer classified by the UT Grade 2 or 3 who meet all of the inclusion and none exclusion criteria and give their informed consent, will receive an application of NEOX CORD 1K in addition to standard of care procedures. Those patients will be seen in follow-up at weekly visits until the wound closes and epithelize, achieving complete closure. Subjects that do not achieve complete ulcer closure prior to or at the end of the 16 treatment weeks will exit the study.

Study PDA-002-DFU-003 is a Phase 2, multicenter, randomized, double blind, placebo-controlled, dose range finding study in subjects who have diabetic foot ulcer (DFU) with peripheral arterial disease (PAD). The study will enroll approximately 24 subjects. This study will investigate the hemodynamic effects, clinical efficacy, and safety of 3 monthly intramuscular (IM) injections of PDA-002 in subjects who have DFU with PAD.

Importance of the topic: Lower extremity amputation is a costly complication of diabetes for both the NHS and the patient. Amputation may be avoided if the preceding foot ulceration can be prevented. One method of reducing the risk of ulceration in the neuropathic foot is through the provision of therapeutic insoles. The type of insole prescribed (prefabricated verses custom made) is currently based on anecdotal evidence. The idea held by many practitioners that the custom made insole is superior in its effect remains speculation, unsupported by the evidence. In the absence of economic analysis, the available data suggests that the custom insole is substantially more expensive to the NHS. This study, to determine which of two types of insole used in therapeutic shoes reduces peak pressure more in the at-risk diabetic foot, is therefore a very important topic and will provide both useful evidence for the NHS podiatry services. It is of course also very important for patients with diabetes as the personal suffering of those undergoing amputation is immense. The study is a single blind randomised controlled trial comparing custom made with 'off the shelf' insoles.

We evaluated the feasibility of the GlideSoft™ novel insole to reduce pressure and shear forces on the foot. No commercially available insoles are designed to reduce shear. Although insurance providers spend millions on diabetics' therapeutic insoles, there is no scientific data about shear or pressure reduction. We will evaluate the optimal bonded materials from Phase I compared to the Glidesoft™ design using the same combination of viscoelastic materials. We evaluate 2 patient groups of 150 patients per arm (300 total) in an 18 month trial. The control group patient arm wore a traditional bonded insole whereas another the second arm receive the GlideSoft™. At baseline, and at the end of the 18 month trial, in-shoe gait lab and in vitro biomechanical parameters measured pressure, shear, and material properties as these changed with wear. This Phase II eighteen (18) month clinical trial evaluated the effectiveness of ShearSole™ reducing the incidence of diabetic ulcers. The overall study hypothesis was that GlideSoft™ provides significant shear reduction as compared to traditional insoles without sacrificing pressure reduction characteristics or durability.

Aim: To develop the Mobile Diabetic Foot Personal Care System (m-DAKBAS) related to foot care for diabetic individuals and to evaluate its effectiveness. Method: The study involved 88 patients who applied to the Diabetes Polyclinic (intervention=44; control=44). While the intervention group used m-DAKBAS (for 6 months), the control group was provided with a verbal foot care training once, as a standardized procedure of the hospital. Data were collected using the "Socio-demographic Form", "Diabetic Foot Knowledge Form - DFKF", "Foot Self Care Behaviours Scale -FSCBS", "Diabetic Foot Care Self Efficacy Scale - DFCSES", and "m-DAKBAS Assessment Form".

Brief description: Diabetic foot ulcer (DFU) is described as a full-thickness lesion appearing at the skin of the foot along with infection, destruction of tissues due to neuropathy and/or peripheral artery disease (PAD) in people with diabetes (International Working Group on the Diabetic Foot, 2015). DFU commonly develops in middle-aged diabetic patients due to a long period of type 2 diabetes and poor adherence to control blood glucose level (Madanchi et al., 2013). Prevalence of DFU was four times higher than all combined cases of cancers in the world (Boulton, 2013; McInnes, 2012; Shaw, Sicree, & Zimmet, 2010). Numerous published studies have documented the rate of DFU at around 25% in Western Population (Boulton, 2013). Prevalence of DFU was stated between 7.3 % - 24 % at Indonesia hospitals (Soewondo, Ferrario, & Tahapary, 2013). An Indonesia nursing study recorded 12 % of diabetic foot ulcer cases from 249 individuals with type 2 diabetes in a regional hospital of Eastern Indonesia (Yusuf et al., 2015). Cases of infected DFU occurred in 98 patients in Sardjito Hospital Yogyakarta Indonesia in 2016 (Longdong, 2016). In order to diminish the wide-reaching impact of DFU, a number of efforts have been performed in Indonesia. A study documented that sufficient diabetic patients' knowledge in performing foot care is able to decrease the incidence of DFU as well as LEA (Wulandini, Saputra, & Basri, 2013). Foot ulcers health education program was interrelated with patients' knowledge as well as attitudes concerning responsibility and involvement in DFU care (Arianti, Yetti, & Nasution, 2012; Mahfud, 2012; Sa'adah, Primanda, & Wardaningsih, 2016; Yoyoh, Mutaqqin, & Nurjanah, 2016). In line with their findings, another study confirmed that intensive health promotion increased patients' knowledge and practice in regard to perform routine foot care (Abbas, 2013). Also, health promotion intervention improves Hemoglobin A1c (HbA1c) in type 2 Diabetes (Brown, 1990; Norris, Lau, Smith, Schmid, & Engelgau, 2002; Florkowski, 2013). However, a number of these studies merely focused on the patient, not engaged family members as it may potentially reduce the effectiveness of therapy. Accordingly, DFU is currently being a critical problems needs to be solved in Indonesia. Ensuring the engagement of both the patients and their families in treatment is an important strategy to deal with the chronic conditions (Baig, Benitez, Quinn, & Burnet, 2015; Miller & DiMatteo, 2013; Pamungkas, Chamroonsawasdi, & Vatanasomboon, 2017). Therefore, conducting a comprehensive intervention of DFU partnering individuals and their families in association with self-and family management is a groundbreaking and challenging strategy to overcome problems on DFU. We believe the findings of our study will render significant contributions to the national guideline of diabetes in Indonesia and prevention of LEA in nursing practice. Furthermore, it will be able to give promising results for accelerating DFU healing. Purposes of the study: The purpose of this study is to investigate the effect of a self- and family management of DFU programs on health outcomes as follows: behaviors (adherence to physical activities, medications, diet, foot care, and blood glucose control), family supports, biomarkers (HbA1c, wound size) in patients suffering DFU in Indonesia. Hypothesis: The study participants who joined completely the self- and family management of diabetic foot ulcer programs during three months would have a better behavior, biomarkers, and family supports than those who received the usual care.

Foot self-management is important in preventing diabetic foot ulcers. However, even when individuals care for their feet, the signs of inflammation are often missed. A tool that will identify inflammation, a sign of initial tissue damage, may be needed. Previous research has shown that foot temperature self-monitoring reduced ulcer incidence by providing a warning sign of inflammation. However, these studies used an expensive medical thermometer. The objectives for this mixed-methods study are: (1) to determine if a foot health intervention that utilizes an inexpensive commercially-available infrared thermometer (CAIT) improves foot outcomes for individuals with diabetes; (2) to identify factors impacting foot self-management; (3) and to explore the participants', family and support persons', and healthcare providers' experiences with foot self-management and the intervention. This study will have three phases: Phase 1, patients, family and support person, and healthcare providers will share their insights regarding foot self-management to inform the intervention; Phase 2, a six-month RCT will assess the effectiveness of a CAIT; Phase 3, interviews will be conducted with participants, family and support persons, and health providers to explore their experiences with the intervention.

Diabetic foot ulcers are associated with high risk of amputation. About 50% of patients undergoing non-traumatic lower limb amputations are diabetics5. The 5-year amputation rate is estimated to be 19% with a mean time to amputation 58 months since the onset of an diabetic foot ulcer6.Because infection and tissue hypoxia are the major contributing factors for non-healing diabetic foot ulcers, hyperbaric oxygen therapy (HBO) carries a potential benefit for treating these problematic wounds that do not respond to standard therapy. The role of oxygen in the wound healing cascade and subsequent combatting action against bacterial invasion, especially anaerobes, is well documented.14 Delayed or arrested healing and the development of infection is a direct result from decreased perfusion and poor oxygenation of tissue.15 The presence of wound hypoxia is an major etiological pathway in the development of chronic non-healing diabetic foot ulcers

In 2011, the premiers of all Canadian provinces and territories selected diabetes foot care as 1 of 3 significant targets for pan-provincial action. Of 210,000 people with diabetes in Alberta, 5,250 will seek treatment of a foot ulcer annually. In Alberta in 2014-15 there were 425 lower limb amputations (LLA). Moreover, there is a tremendous reduction in quality of life of the patients and attendant negative effects on their families. The 5-year mortality rate after new-onset diabetic foot ulcer is 43-55% and as high as 74% for patients undergoing LLA (CIHI, 2013). The Diabetes Foot Care Clinical Pathway Project (DFCCPP) aims to optimize methods of early detection and treatment of foot ulcers in an effort to reduce LLA by 50% by implementing High Risk Foot Teams (HRFTs) across the province starting with 3 Pilot sites. Existing staff with expertise and knowledge in diabetic foot care will assess and treat patients with moderate and high-risk findings. In conjunction with the DFCCPP, the efficacy of a technological advancement developed by an Alberta-based small-to-medium enterprise (SME) to improve diabetic foot outcomes will be evaluated. Exsalt® SD7 Wound Dressings (Exciton Technologies, Edmonton, AB) have been demonstrated in-vitro and in-vivo to provide rapid and effective antibacterial activity in an easy-to-use format, thus creating an enhanced wound healing environment while supporting patient quality of life. The objective of the proposed work is twofold, namely 1) to quantify clinical efficacy of exsalt® Wound Dressings on locally infected diabetic foot ulcers not progressing to healing under the current standard of care: evaluating key indicators of infection, Infectious Diseases Society of America (IDSA) wound classification, and wound size; identifying benefits to foot ulcer healing and 2) to evaluate subjective patient outcomes: satisfaction, perceived benefit, compliance. Evaluating the benefits of utilization of the Exciton exsalt® Wound Dressings when combined with the DFCCP.

This research presents a randomized clinical trial which analyzes the efficacy of a rigid rocker sole in the reduction of the recurrence rate of plantar ulcers in diabetic foot patients. The hypothesis of the research is the use of a rigid rocker sole reduces the recurrence rate of diabetic foot ulcers in patients with peripheral neuropathy.