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Amputation clinical trials

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NCT ID: NCT05446337 Not yet recruiting - Diabetes Clinical Trials

Diabetic Foot Care and Limb Preservation Pathway: Developmental Evaluation Study

Start date: July 15, 2022
Phase:
Study type: Observational

University Health Network (UHN), working together with local primary care practitioners, patients, and community healthcare services is developing a Diabetic Foot Care and Limb Preservation Care pathway. Our goal is to improve foot care for individuals living with diabetes. This study is using a method called developmental evaluation to help map out the system and to provide information in real-time so that the pathway can be adapted and respond to what is learned. The investigators are going to explore different factors (facilitators and barriers) and processes, which help or hinder the development, implementation, and adoption of the pathway. The investigators are also going to find out about the patient and provider's experiences with diabetic foot care, wound care, limb preservation, and amputation. Finally, the study team is going to look at value-based health care for the diabetic foot care pathways and document healthcare resource utilization, costs, and outcomes. The study team will conduct interviews of stakeholders, including patient representatives, and will examine the participation and engagement in the pathway, identifying barriers and facilitators of the process. Once the pathway has started, the study team will look at the way the care is delivered and satisfaction through surveys to patients and practitioners. The study team will also ask about patients' quality of life and their ability to manage diabetes. The study will aim to answer three key questions: What is happening? Why is it happening? and, What are reasonable prospects, and tools for change? The entire study is anticipated to take 3 years to complete.

NCT ID: NCT05261178 Not yet recruiting - Amputation Clinical Trials

Evaluation of Satisfaction and Effect on Daily Living Activities With the Use of Myoelectric Controlled Prosthesis

Start date: October 1, 2022
Phase:
Study type: Observational

Myoelectrically controlled arm prostheses are often offered to individuals with upper extremity limb loss in order to restore body balance and compensate for the lack of grasping ability during the rehabilitation process. Myoelectrically controlled prostheses utilize the presence of two independent signals from a set of agonist and antagonist muscles. However, individuals with upper extremity amputation may not want to use their prosthesis. One of the reasons for not wanting to use the prosthesis is prosthesis dissatisfaction. This study aims to evaluate prosthesis satisfaction and the effect of prosthesis use on daily living activities of upper extremity amputees using myoelectric controlled prosthesis.

NCT ID: NCT05220553 Not yet recruiting - Amputation Clinical Trials

A Sensorimotor Prosthesis for the Upper Limb

PROLIMB
Start date: March 31, 2022
Phase: N/A
Study type: Interventional

The finger and fingertip are the most frequently amputated body parts, due to work-related incidents. Yet because of space, weight and cost constraints, prosthetic fingers and fingertips are heavy and bulky with limited active motion and sensation. Most are basic variations on the hook and claw. Lower limb prostheses have become extremely technologically advanced in their design and materials, and upper limbs lag behind in all of these areas. This is due to the complexity of the anatomy and function of the upper limb compared to the lower. There are no commercially available prostheses that offers direct sensory feedback and as such, rely on visual feedback from the wearer. The original PROLIMB study (PROLIMB I) used a Leap Motion Controller (LMC) to investigate the type of grasp adaptation that have been undertaken by patients during the rehabilitation process following amputation and compared this to similar data from healthy volunteers. PROLIMB I also looked at refining the tactile feedback system by investigating the sensation felt on amputation sites in order to feed this information into the haptic feedback system. The vision of the PROLIMB II project is to build on the work completed in PROLIMB I and develop and combine mechanistic models of hand motion and haptic sensing to deliver novel, affordable body-powered prosthetic fingertip digits with enhanced motion and sensation to address current clinical needs and support the quality of life of amputees. With collaboration from the University of Warwick (UoW) and University College London (UCL), Steeper Group and Naked Prosthetics the PROLIMB II study will aim to model, design, fabricate and validate a body-powered prosthetic fingertip digit with integrated sensory feedback. The University Hospital Coventry & Warwickshire (UHCW) will provide the clinical facility with which to assess the comfort, usability and acceptance of this prosthetic in the daily lives of patients with digit amputations. This project will be a proof of concept study with verification of the prosthetic in motion capture (gait) laboratories as well as the use of simple validation data collection over a longer period.

NCT ID: NCT05072353 Not yet recruiting - Diabetic Foot Ulcer Clinical Trials

Effectiveness of the Autologous Adipose Tissue Harvested With SEFFICARE Method for Treatment of DFU Minor Amputation

SEFFIDiFA
Start date: December 2021
Phase: N/A
Study type: Interventional

Diabetic foot ulcers (DFU) are one of the complications of diabetes mellitus resulting from multiple causes such as neuropathy, ischemia, and infection that contribute to morbidity and amputation. The prevalence of DFU has been estimated to be 3 to 5 times higher than the overall population. Minor amputations (digital or transmetatarsal) are the treatment of choice in case of irreversible DFU. However, many minor amputations do not heal and require re-amputation. Improvements of healing rate after adipose stem cells (ASCs) injection through micro-fragmented autologous adipose tissue of the amputation stump following minor DFU amputation were demonstrated. The use of ASCs obtained from the superficial enhanced fluid fat injection technique (SEFFICARE) to improve the healing process after DFUs minor amputation is the object of the present study. A single-center non-randomized prospective observational study will be performed. The recruited patients will undergo local injection of superficial enhanced fluid fat after a lower limb minor amputation. Laboratory analysis to evaluate the composition of the tissue and stromal cell components harvested from adipose tissue with SEFFICARE system by using digital droplets PCR. These data will serve for making associations between the clinical outcome and characteristics of the cell population administered to each patient.

NCT ID: NCT04953364 Not yet recruiting - Amputation Clinical Trials

Self-Management for Amputee Rehabilitation Using Technology.

SMART
Start date: August 15, 2022
Phase: N/A
Study type: Interventional

Lower Limb Amputations (LLAs) are a substantial burden on the Canadian health services with nearly 50,000 cases reported between 2006 and 2011. To address the challenging nature of a LLA (e.g., decreased mobility, pain, depression), patients need to go through extensive rehabilitation programs. Effective self-management programs can help those with LLA to monitor their own condition and improve their quality of life. However, a lack of self-management programs, a limited healthcare budget, and a decrease in quality of services (e.g. shorter lengths of stay for inpatients and rapid movement to outpatient services) pose further challenges for patients with LLA. Self-management programs can be provided to clients through online mobile technologies (e.g., tablet) and offer accessible, low-cost, and potentially augmentative rehabilitation after discharge, in both urban and rural areas. To address these needs, an online educational and training platform for individuals with LLA called, Self-Management for Amputee Rehabilitation using Technology (SMART) was designed and developed. SMART focuses on LLA education, prosthetic limb management, and weekly support of peers. It is monitored by a trainer through a website. SMART will be evaluated in men and women with LLA aged 50 years and over, admitted to prosthetic rehabilitation throughout BC and ON. SMART has the potential to influence a client's post-LLA needs with direct (e.g., individual's health) and indirect (e.g., healthcare utilization) benefits. The purpose of this randomized controlled trial is to evaluate the effect of SMART in community dwelling older adults with unilateral, above or below, knee amputation.

NCT ID: NCT04936789 Not yet recruiting - Amputation Clinical Trials

Clinical Feasibility of the IMES Transradial Prosthesis

Start date: September 2021
Phase: N/A
Study type: Interventional

This study will evaluate the feasibility of using implanted myoelectric sensors (IMES) to control a transradial prosthesis

NCT ID: NCT04599530 Not yet recruiting - Amputation Clinical Trials

A Comprehensive Evaluation of a the Talaris Demonstrator

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

The Talaris Demonstrator is developed in continuation of previous prototypes called the AMPfoot 2.0, 3.0 and 4.0. The main goal of the experiment is to evaluate the effectiveness of TD during daily activities.

NCT ID: NCT04578327 Not yet recruiting - Amputation Clinical Trials

Investigation of Embodiment for Upper Limb Amputees

NISRL
Start date: June 2, 2025
Phase: N/A
Study type: Interventional

Today, prosthetic hands are numb. They provide no tactile or proprioceptive sensory information back to the user. The lack of sensory feedback has been shown to reduce the utility of a prosthesis by half. The prosthesis is seen as a tool, not as an incorporated part of the body schema. Only now are there chronically-implantable technologies which can provide physiologically appropriate sensory feedback to upper limb amputees to recreate tactile and proprioceptive percepts. These sensations are the building blocks to enable the embodiment of the device. Furthermore, newly developed outcome measures are now available which can detail the improved embodiment such neural interfaces can create. The investigator's mission is to enable the embodiment of artificial devices using peripheral nerve stimulation and thereby close the gap between the experience of our intact physiological systems and those using prosthetic remedies. This investigation of embodiment for upper limb amputees is organized into three main areas of work including 1) normative data collection, 2) device development, and 3) characterization of embodiment using peripheral nerve stimulation. The normative data collection will quantify the embodiment of conventional cosmetic, body-powered, and myoelectric prosthetic hand options using a modified Rubber Hand Illusion protocol (Specific Aim 1). This thrust will ask how does the amount of embodiment vary among conventional prosthetic hands as well as probe the relationship between agency and embodiment. The device development project entails the design of multi-modal sensors in order to study full-hand embodiment (Specific Aim 2). The ability to measure and then elicit sensation on the passive surfaces of the hand (palm, ulnar border, and dorsal surface) has never been explored. Here, a multi-modal sensor which can detect proximity, contact, and force will be integrated into a commercially available prosthetic hand in order to provide detailed measurements across the palm, ulnar border, and dorsal surfaces in order to study embodiment in more depth. Finally, the characterization of embodiment using peripheral nerve stimulation will take place over a multiple subject factorial experiment which quantifies the effects of quantity and spatial parameters of the peripheral nerve stimulation on the embodiment of prosthetic hands (Specific Aim 3). This study asks what somatosensory percepts from the hand are most critical for embodiment by varying the parameters of the peripheral nerve stimulation (quantity and spatiality) and measuring the level of embodiment in each case.

NCT ID: NCT04427124 Not yet recruiting - Clinical trials for Peripheral Arterial Disease

The CLI-AMP Registry

CLI-AMP
Start date: August 1, 2020
Phase:
Study type: Observational [Patient Registry]

Single-center, observational registry study with a prospective and retrospective arm to evaluate the impact of multidisciplinary CLI teams and protocol on amputation rates, vascular studies, revascularization, in-hospital and long-term outcomes.

NCT ID: NCT04276467 Not yet recruiting - Amputation Clinical Trials

Development of the ICF Based Amputee Mobility Scale

Start date: April 1, 2020
Phase:
Study type: Observational

Lower limb amputation is a condition that reduces individuals' independence in daily life. Therefore, the main purpose of the rehabilitation process is to reintegrate the person as an independent and productive person as soon as possible. Although scales are frequently used in mobility evaluation in the clinic, they do not measure the advanced activities of patients. Therefore, the aim of the study is to obtain a comprehensive scale evaluating mobility in amputee. The mobility scale will be created using the two-round Delphi method. ICF (International Classification of Functioning Disability and Health) created by the World Health Organization, mobility subheading will be evaluated, and the questions that will be included in the scale will be compiled. In line with the data to be obtained from experts, a scale will be created.Scale and gold standard tests will be applied to patients so that validation of the scale will be investigated.