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Amputation clinical trials

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NCT ID: NCT02738086 Completed - Clinical trials for Diabetes Mellitus, Type 2

Physical Activity Behavior Change for Older Adults After Dysvascular Amputation

PABC
Start date: July 1, 2016
Phase: N/A
Study type: Interventional

This pilot study will use mobile-health technology to deliver an intervention designed for lasting physical activity behavior change. The study will assess the feasibility of using the Physical Activity Behavior Change(PABC) intervention for Veterans with lower limb amputation. This intervention will be delivered using wrist-worn wearable activity sensors and a home-based tablet computer to allow real-time physical activity feedback and video interface between the participants and the therapist.

NCT ID: NCT02685098 Active, not recruiting - Clinical trials for Cardiovascular Disease

A Clinical and Histological Analysis of Mesenchymal Stem Cells in Amputation

CHAMP
Start date: January 23, 2017
Phase: Phase 1
Study type: Interventional

Patients undergoing semi-elective lower extremity major amputation from complications associated with atherosclerotic limb ischemia will received intra-muscular injections of allogeneic Mesenchymal Stromal Cells in the leg above and below the point of amputation to prevent ischemic wound complications after surgery and decrease the incidence of revision and further amputation. Cohort Groups 1-4 will serve as controls.

NCT ID: NCT02678247 Completed - Amputation Clinical Trials

Functional Performance Evaluation of NU-FlexSIV Socket

Start date: April 2016
Phase: N/A
Study type: Interventional

The overall objective of this study is to provide a more comfortable and functional prosthetic socket for persons with transfemoral amputation that will ultimately improve their quality of life.

NCT ID: NCT02476838 Recruiting - Amputation Clinical Trials

Hand Transplantation

Start date: June 2, 2015
Phase: N/A
Study type: Interventional

The purpose of this study is to see if an investigational surgery that transfers tissue from a non-living donor to living individual will help restore greater function, appearance, and sensation to the hand and forearm areas of individuals who have suffered traumatic injury to the hand and forearm. This procedure is called a hand allotransplantation or "hand transplant". This study will also collect data on how patients do during and after having a hand transplant from a nonliving donor. Recovery and outcomes will be observed through clinical exams, x-rays, blood and tissue tests, and other associated evaluations at all follow up visits.

NCT ID: NCT02395497 Recruiting - Amputation Clinical Trials

Human Penile Allotransplantation

Start date: June 2014
Phase: Phase 2/Phase 3
Study type: Interventional

Injuries to the genitalia are of concern to the military with emphasis placed on the surgical reconstruction and psychological health of these Wounded Warriors. However, despite significant surgical advances in microvascular surgery and autologous free tissue transfer, conventional reconstructions cannot truly replace the complicated structures and functions of the penis including the urethra, erogenous sensation, and erectile corporal bodies. Conventional reconstruction poses several challenges: patients may not have sufficient donor tissue due to other injuries or previous surgery; multiple operations are often needed to restore the neophallus; the final reconstruction only approximates the penis' native form; recreating the urethra is challenging and the new urethra is prone to stricture and fistula formation; the erectile function necessary for sexual intercourse is often lacking; and insufficient protective sensation can lead to penile implant extrusion, infection, subsequent explantation or loss of the reconstruction. The investigators propose this clinical trial to determine functional outcomes and quality of life for Wounded Warriors and civilians who choose to undergo penile allotransplantation. The investigators will combine extensive experience performing total penile reconstruction in a large population affected by congenital, traumatic, and therapeutically extirpated Genitourinary deformities and expertise in reconstructive transplantation using an immunomodulatory protocol to for this study. The investigators anticipate penile transplantation can potentially replace "like with like," restoring the appearance, anatomy, and function of the recipient in a manner far superior to autologous reconstruction. This project will establish the ability to perform penile allotransplantation using an immunomodulatory protocol and will compare outcomes with conventional phalloplasty patient results. Study Design: This is a non-randomized subject self-controlled clinical trial to implement a cell-based immunomodulatory protocol for penile allotransplantation. An intermediate deliverable is achieving allograft survival and functional return with reduced dosing/frequency of maintenance immunosuppression on steroid-free monotherapy (tacrolimus) immunosuppression. The long-term deliverable and goal is to demonstrate superior outcomes when compared to satisfaction and QOL in conventional phalloplasty patients 12-60 months post-transplant.

NCT ID: NCT02366702 Active, not recruiting - Amputation Clinical Trials

Kinematic, Kinetic, and Metabolic Comparison of Bilateral Transfemoral Ambulation With Passive Versus Powered Prosthetic Devices

Start date: February 2015
Phase:
Study type: Observational

The purpose of this descriptive and exploratory pilot study is to investigate: (1) sagittal plane hip kinematics and kinetics and (2) metabolic consumption/cost, for bilateral transfemoral walking with passive prostheses versus powered prostheses. The pilot study will collect data from three subjects with bilateral transfemoral amputations. Differences in kinetics, kinematics, and oxygen consumption/cost when comparing passive and powered components may indicate benefits for clinical application of powered devices for persons with lower limb amputation.

NCT ID: NCT02355912 Completed - Amputation Clinical Trials

Adaptive Recalibration of Prosthetic Leg Neural Control System

Start date: January 2015
Phase: N/A
Study type: Interventional

The purpose of this study is for transfemoral amputees to walk with an experimental robotic prosthesis. Electric signals will be measured from their muscles and used to help control an artificial leg. The investigators will record from sensors placed on a prosthesis and electric signals measured from muscles in the participants leg to see if the investigators can develop better computer programs to help predict subject actions and prostheses function.

NCT ID: NCT02076022 Completed - Amputation Clinical Trials

AMP30: Autologous Fat Grafting, Amputation Sites Pain: Randomized

AMP30
Start date: April 8, 2014
Phase: N/A
Study type: Interventional

We propose a prospective, randomized clinical study to assess the efficacy of minimally invasive autologous fat transfer addressing pain and poor prosthetic fit at amputation sites.

NCT ID: NCT01750372 Completed - Amputation Clinical Trials

A Client-Based Outcome System for Individuals With Lower Limb Amputation

Start date: April 2010
Phase: N/A
Study type: Observational

Standardized outcome measures can be used to document patient health outcomes and improve treatment of those requiring prosthetic and orthotic (O&P) services. Though numerous instruments have been developed, existing measures of O&P outcomes have serious shortcomings including limited evidence that the scores are responsive to clinical changes. The investigators are developing the Prosthetic Limb Users Survey-Mobility (PLUS-M) using modern measurement methods to be a brief, precise and flexible measure of mobility for persons with lower limb amputation (LLA). The investigators propose the following objectives to achieve this goal. Key objective 1: develop a measure (item bank) for measuring mobility in persons with lower limb loss Key objective 2: study health profiles of lower limb prosthetic users Key objective 3: validate the measure in a longitudinal study of people receiving replacement prosthetic limbs Key objective 4: study longitudinal health patterns of persons with lower limb amputation

NCT ID: NCT01559909 Completed - Amputation Clinical Trials

Effect of Socket Wall Height With Vacuum Suspension for Above Knee Amputees

Start date: June 2012
Phase: Phase 1
Study type: Interventional

Individuals with transfemoral (TF) amputation (above the knee amputation) may benefit from a socket that uses vacuum assisted suspension (VAS) to hold the socket onto the amputated limb. VAS may improve stability, weight bearing, comfort, proprioception, limb health, and function. To date, there is no evidence to support whether VAS alters balance, kinematics, and kinetics when walking for TF amputees as compared to conventional socket suspension technology. Further, there is question regarding what the optimal height of the socket should be to maintain stability and function. So long as stability is not sacrificed, it may be advantageous to lower the height of the socket to allow full hip motion and improve sitting comfort. The purpose of this investigation is to assess if the socket height alters the motion of the leg and changes the way one walks when using VAS compared to conventional socket suspension technology. In this study, TF amputees will be fitted with a VAS socket that will be attached to their current prosthesis using similar alignment. Individuals will be assessed while walking on a level floor and during stair negotiation while wearing the prosthesis with the VAS socket at various socket heights as well as their current socket. Additionally, balance and socket standing and sitting comfort will be investigated.