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Amputation clinical trials

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NCT ID: NCT04536025 Active, not recruiting - Amputation Clinical Trials

Shared Decision Making Aid for Prosthetic Design

D-MAP
Start date: June 6, 2020
Phase:
Study type: Observational

This study is designed to learn more about decision making for prosthetic design, with the goal of producing a decision making aid for prosthetic design decisions.

NCT ID: NCT04520841 Recruiting - Amputation Clinical Trials

Clinical Trial Comparing Negative Pressure Wound Therapy and Standard Dry Dressings

BERLYTZ
Start date: June 1, 2020
Phase: N/A
Study type: Interventional

Negative pressure dressings are currently widely used in wound management. Their use is gradually being extended to surgical scars. However, studies demonstrating a clear benefit are rare, particularly in terms of postoperative discharge, the need for surgical revision due to prolonged oozing and cost. The aim of this study is to evaluate the benefit of such a device in post-operative revision prosthesis surgery (hip and knee), as well as lower limb amputations.

NCT ID: NCT04484805 Completed - Amputation Clinical Trials

Socket Cooling Effectiveness Take Home Study

Start date: August 1, 2019
Phase: N/A
Study type: Interventional

The comfort and fit of the residual limb within a prosthetic socket are of primary concern for many amputees. The residual limb is typically covered by non-breathable and non- thermally conductive materials that can create a warm and ultimately moist environment. To address this, Liberating Technologies, Inc. (LTI) and Vivonics, Inc. have developed a thermo-electric cooling (TEC)-based module called the Intrasocket Cooling Element (ICE), that can be embedded into the prosthesis in order to cool the residual limb. A technology that can provide thermal control while retaining adequate suspension, weight and other prosthetic characteristics would benefit many prosthesis wearers.

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: NCT04427007 Completed - Amputation Clinical Trials

Moisture Management Liner Effectiveness Study

Start date: July 1, 2020
Phase: N/A
Study type: Interventional

The comfort and fit of the residual limb within a prosthetic socket are of primary concern for many amputees. The residual limb is typically covered by non-breathable and non- thermally conductive materials that can create a warm and ultimately moist environment. The investigators have developed a silicone liner approach to remove sweat from the skin and out of the socket and to passively conduct heat from the skin using thermally conductive elastomers. This liner has been developed to work alongside a thermo-electric cooling (TEC)-based module called the Intrasocket Cooling Element (ICE) developed in a parallel project by Vivonics, Inc. and Liberating Technologies, Inc. The ICE device can be embedded into the prosthesis in order to cool the residual limb. A technology that can provide thermal control while retaining adequate suspension, weight, and other prosthetic characteristics would benefit many prosthesis wearers.

NCT ID: NCT04422717 Completed - Amputation Clinical Trials

Femoral Cartilage Thickness In Patients With Lower Limb Amputation

Start date: February 15, 2019
Phase:
Study type: Observational [Patient Registry]

The aim of the study to investigate any relation with functional parameters and femoral cartilage thickness evaluation by ultrasonography in lower extremity amputate individuals.

NCT ID: NCT04392466 Recruiting - Amputation Clinical Trials

Comparison of Dual Task Gait Characteristics in Individuals With Amputation and Healty Individuals

Start date: February 15, 2020
Phase:
Study type: Observational

In amputee, dual task has been found to cause a decrease in walking speed. However, there is no study of how gait characteristics are affected when the speed does not change. The aim of this study is to compare the time-distance characteristics of walking with single task, cognitive dual task, motor dual task in transtibial, transfemoral amputee and healthy people.

NCT ID: NCT04388488 Recruiting - Amputation Clinical Trials

Connect TF - An Investigation of Function and Usability of a New Adaptable Socket System

Start date: August 3, 2020
Phase: N/A
Study type: Interventional

The primary objective of this investigation is to evaluate how the CONNECT TF compares to traditional handmade sockets, specifically that it provides reliable suspension and improved usability and comfort for the amputee, and that it enables single clinical visit for fitting.

NCT ID: NCT04378062 Terminated - Pain Clinical Trials

Pain After Proximal Digital Amputation Prevention

PAPDAP
Start date: March 1, 2020
Phase: N/A
Study type: Interventional

Finger amputations are common and may be complicated by debilitating nerve pain. This study seeks to determine if nerve pain after digital amputation can be more effectively prevented with either of two new surgical techniques-targeted muscle reinnervation (TMR) or regenerative peripheral nerve interfaces (RPNI)-compared to standard treatment by traction neurectomy (TN).

NCT ID: NCT04360421 Terminated - Opioid Use Clinical Trials

Use of Long-acting Bupivacaine In Lower Extremity Amputation

Start date: April 21, 2020
Phase: Phase 4
Study type: Interventional

The purpose of this investigator-initiated study is to assess the use of liposomal bupivacaine in major extremity amputation and its effects on post-operative opioid narcotic use, length of stay, and in-hospital costs. Liposomal bupivacaine is an encapsulated, injectable amide anesthetic intended for use in long-acting local anesthesia. It has been shown in randomized trials to be effective in reducing post-operative pain while reducing opioid narcotic use and length of hospital stay following several surgical procedures, particularly after total knee arthroplasty. Extremity amputation is a painful operation often performed in seriously ill or debilitated patients, often related to infection, trauma or malignancy. Application of liposomal bupivacaine in extremity amputation is not well described. The investigators intend to enroll adults greater than age 18 years of age who are to undergo major extremity amputation. Patients will receive targeted injections of liposomal bupivacaine during their procedure. Patient pain scores, total opioid use, and length of hospital stay will be tracked. Patients receiving liposomal bupivicaine will be compared to similarly matched subjects who received standard anesthesia regimens without liposomal bupivicaine. The investigators hypothesize that liposomal bupivicaine used during major amputation decreases opioid use, hospital stay, and in-hospital costs.