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Leg Injuries clinical trials

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NCT ID: NCT00985842 Completed - Amputation Clinical Trials

Study to Determine if Different Prosthetic Sockets Effect How Much Oxygen is in the Tissue of Lower Limb Amputees While They Are Walking

Start date: November 1, 2009
Phase: N/A
Study type: Interventional

Amputee gait produces periodic occlusion of residual limb blood vessels. During the stance phase of gait, body weight cause the prosthesis to compresses the soft tissue of the residual limb and occlude blood flow. This occlusion can be relieved during swing phase, but may depend on type of prosthesis. The purpose of the proposed research is to: (1) discover the range of tissue oxygenation in the intact and residual lower limbs of dysvascular amputees during gait and (2) to learn which of five different prosthetic limb systems provides greater tissue oxygenation.

NCT ID: NCT00906672 Completed - Ankle Injuries Clinical Trials

Medico Economic Evaluation of Dermal Substitute Integra® for Coverage of Inferior Limb Traumatic Skin Loss

INTEGRA®
Start date: June 2009
Phase: Phase 3
Study type: Interventional

Comparison of 2 techniques of surgery on patients with inferior limb traumatic wounds: the innovative technique Integra® and the technique of reference: the flap surgery.

NCT ID: NCT00869947 Completed - Clinical trials for Traumatic Amputation of Lower Extremity

Effects of Wearing a Powered Ankle-Foot Prosthesis on Amputee Walking

Start date: March 2009
Phase: N/A
Study type: Interventional

Amputees wearing a conventional prosthesis require 20-30% more metabolic energy to walk at the same speeds as non-amputees and this discrepancy is more apparent at faster walking speeds. Amputees choose to walk at speeds 30-40% slower than non-amputees. Preferred walking speed is likely influenced by elevated metabolic energy, but the underlying reason for slower preferred walking speeds is not fully understood. Unilateral amputees exhibit highly asymmetrical gait patterns that likely require more metabolic energy and impair functional mobility, increasing the risk of degenerative joint disease, osteo-arthritis and lower back pain. Improvements in prosthetic devices could enhance mobility in amputees, thus positively effecting rehabilitation and ambulation in veterans. A prosthesis that allows amputees to reduce metabolic energy would be especially useful for rehabilitation in older, ill individuals with reduced exercise capacities and could literally restore walking ability in people that are currently non-ambulatory. Hypotheses. Amputees wearing the Massachusetts Institute of Technology (MIT) Powered Ankle-Foot (PAF) prosthesis will have a lower metabolic cost, faster preferred walking speed, and improved gait symmetry during walking than amputees wearing a conventional prosthesis and will have nearly the same metabolic cost, preferred walking speed, and gait symmetry during walking as age, gender, height, and weight matched non-amputees.

NCT ID: NCT00167778 Completed - Diabetes Mellitus Clinical Trials

Prosthetic Components and Stability in Amputee Gait

Start date: January 2005
Phase: N/A
Study type: Interventional

The biomechanics of changing direction while walking has been largely neglected despite its relevancy to functional mobility. In addition, an increased risk of injury can be associated with turning due to a decrease in stability. The objective of this study is to understand the biomechanics of turning gait in sample populations of intact and trans-tibial amputees and the capacity of prosthetic components to facilitate transverse plane movement. The clinical impact of this investigation is the development of interventions that increase functional mobility, stability and safety while turning. The researchers propose to investigate three sets of hypotheses. The first set addresses the fundamental biomechanical mechanisms associated with walking along a circular trajectory, how intact subjects differ from amputees, and the effect of a rotation adaptor pylon. The second set of hypotheses addresses dynamic stability and the potential influence of prosthetic interventions. The third set of hypotheses addresses how the rotational properties of the prosthetic pylon can influence comfort and mobility during daily activities.

NCT ID: NCT00117793 Completed - Diabetes Clinical Trials

Vacuum Suspension: Effects on Tissue Oxygenation, Activity and Fit

Start date: August 2005
Phase: N/A
Study type: Interventional

The fit of the residual limb within a prosthetic socket is a primary concern for many amputees. A poor fit can lead to skin irritation, tissue breakdown, and pain. Further, amputees with diabetes or vascular dysfunction often have difficulty maintaining healthy residual limb tissue; a condition that could be mitigated by the application of negative pressure (i.e., vacuum suspension). The aim of this research is to characterize the residual limb response to a vacuum suspension system and to measure prosthetic performance in comparison to a typical suction suspension system. The proposed research plan involves two sets of human subject experiments: (1) prospective, randomized cross-over study to quantify performance of a vacuum suspension system as compared to a total surface bearing suction socket in terms of pistoning, maintaining limb volume, step counts, and subjective measures of fit and (2) measurement of transcutaneous oxygen tension as a function of vacuum pressure.