Clinical trials: Leg Amputation
Lower Limb Amputation Above Knee (Injury)
C-Leg 3 and C-Leg 4 Study in Transfemoral Amputees
The aim of this post-market study is to confirm that the microprocessor controlled prosthetic knee components (C-Leg 3 and C-Leg 4) in comparison to mechanical knee joints can bring additional benefit to the users primarily on…
- Trial name
- NCT02765035
- Testing
- C-Leg 4, C-Leg 3
- Where
- 2 sites in Austria, Belgium
- Volunteers
- 18 people
- Sponsor
- Otto Bock Healthcare Products GmbH
Surgical Wound, Diabetes
EO2 Oxygen Delivery To Study Success Rate of Surgically Closed Wounds
The investigators will test the efficacy of the novel oxygen diffusion dressing allows delivery tissue oxygenation via TransCu O2® Oxygen Delivery System for use in caring for patients with surgically closed wounds.
- Conditions
- Surgical Wound, Diabetes, Amputation Wound, Incision Wound
- Trial name
- NCT03960463
- Testing
- Transcu O2®
- Where
- United States
- Volunteers
- 33 people
- Sponsor
- Baylor College of Medicine
Peripheral Artery Disease
Efficacy and Safety of Rivaroxaban in Reducing the Risk of Major Thrombotic Vascular Events in Subjects With Symptomatic Peripheral Artery Disease Undergoing Peripheral Revascularization Procedures of the Lower Extremities
The purpose of study was to test whether rivaroxaban added to standard of care treatment, when compared to placebo, had the potential to reduce the incidence of the clinical events related to the clots and complications of the…
- Trial name
- VOYAGER PAD (NCT02504216)
- Testing
- Rivaroxaban (Xarelto, BAY59-7939)
- Where
- 532 sites in United States, Argentina and 32 more
- Volunteers
- 6,564 people
- Sponsor
- Bayer
Other and Unspecified Complications of Amputation Stump
Comparative Outcomes Assessment of the C-Leg With a New Knee Prosthesis
The purpose of this study is to determine if transfemoral amputees of varied etiology will demonstrate increased function, safety and quality of life following accommodation with a new knee prosthesis as compared to their former…
- Trial name
- NCT01473992
- Testing
- Otto Bock C-Leg, Otto Bock Genium
- Where
- United States
- Volunteers
- 25 people, healthy volunteers welcome
- Sponsor
- Jason Highsmith
Critical Limb Ischemia, Peripheral Arterial Disease
Safety and Efficacy Study of Autologous Concentrated Bone Marrow Aspirate (cBMA) for Critical Limb Ischemia (CLI)
This trial will evaluate the safety and efficacy of concentrated bone marrow aspirate (cBMA) to prevent or delay major amputation and/or death in subjects with critical limb ischemia (CLI) due to severe peripheral arterial…
- Conditions
- Critical Limb Ischemia, Peripheral Arterial Disease, Peripheral Vascular Disease
- Trial name
- MOBILE (NCT01049919)
- Testing
- Bone marrow concentration device
- Where
- 25 sites in United States
- Volunteers
- 153 people
- Sponsor
- Zimmer Biomet
Lower Limb Amputation Below Knee (Injury)
Auto Control of Volume Management for Limb Loss
The aim of this research is to create a prosthetic system that will automatically adjust the fit of the socket and create a well-fitting prosthesis for people with leg amputations who experience volume fluctuations when using…
- Trial name
- NCT03550118
- Testing
- Adjustable socket
- Where
- United States
- Volunteers
- 104 people
- Sponsor
- University of Washington
Trauma Injury
ICG Fluorescence Imaging in Lower Extremity Amputation Patients
This is a non-randomized prospective study of 30 patients scheduled to undergo lower extremity amputation (below the knee, through the knee or above the knee) evaluating bone perfusion and viability using indocyanine green (ICG)…
- Trial name
- NCT04250558
- Testing
- Lower Extremity Amputation
- Where
- United States
- Volunteers
- 17 people
- Sponsor
- Dartmouth-Hitchcock Medical Center
Lower Extremity Amputation
Weight Loss Intervention for Individuals With Lower Extremity Amputation
The purpose of this study is to pilot test a program to help overweight and obese individuals with a lower extremity amputation (LEA) lose weight and become more physically active.
- Trial name
- MOVE-LEAP (NCT02085785)
- Testing
- Coached group, Self-directed control group, Screened only
- Where
- United States
- Volunteers
- 15 people
- Sponsor
- VA Office of Research and Development
Lower Limb Amputation Below Knee (Injury)
Wear and Tear Evaluation of New Nike Sport Sole for Runnnig Prosthesis
Running Specific Feet are based on the original Flex-Foot design using the energy storage and release function as the main design feature. Running specific prosthetic feet are intended for running and jogging.
- Trial name
- NCT04787640
- Testing
- Nike Sport Sole
- Volunteers
- 3 people
- Sponsor
- Össur Iceland ehf
Lower Limb Amputation
Development of Adaptive Vacuum Suspension to Improve Prosthetic Fit and Residual Limb Health
The purpose of the study is to evaluate residual limb circulation and skin health associated with the use of a prosthetic vacuum socket. A conventional non-vacuum prosthetic socket will be compared to a vacuum prosthetic socket.
- Trial name
- DoD (NCT03927404)
- Testing
- Active vacuum test prosthesis
- Where
- United States
- Volunteers
- 60 people
- Sponsor
- Indiana University
Traumatic Amputation of Lower Extremity
Effects of Wearing a Powered Ankle-Foot Prosthesis on Amputee Walking
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.
- Trial name
- NCT00869947
- Testing
- Powered ankle-foot prosthesis, No device
- Where
- United States
- Volunteers
- 16 people, healthy volunteers welcome
- Sponsor
- US Department of Veterans Affairs
Amputation
Clinical Evaluation of Direct Manufactured Prosthetic Sockets
The purpose of this study is to evaluate a new prosthetic socket construction technique in order to improve the quality of care to lower extremity amputees.
- Trial name
- NCT01155024
- Testing
- Traditional fabricated prosthetic socket, Direct manufactured (DM) prosthetic socket
- Where
- United States
- Volunteers
- 10 people
- Sponsor
- Ohio Willow Wood
Amputation Stumps, Amputees
Moisture Management Liner Effectiveness Study
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…
- Conditions
- Amputation Stumps, Amputees, Amputation, Lower Limb Deformities, Congenital
- Trial name
- NCT04427007
- Testing
- Moisture Management Liner, Control Liner
- Where
- United States
- Volunteers
- 2 people, healthy volunteers welcome
- Sponsor
- Liberating Technologies, Inc.
Diabetes Mellitus, Type 2
This Study Combines Data From 3 Other Studies Testing Empagliflozin in Patients With Diabetes or With Chronic Heart Failure. The Study Looks at the Numbers of Patients Who Had Lower Limb Amputations
The primary objective of this exploratory meta-analysis is to evaluate the frequencies, incidence rates, and hazard ratios of lower-limb amputation (LLA) events (primary outcome) and of adverse events related to amputation…
- Trial name
- NCT04937816
- Testing
- Empagliflozin
- Where
- Germany
- Volunteers
- 16,746 people
- Sponsor
- Boehringer Ingelheim
Phantom Limb Pain
Mixed Reality Based System to Manage Phantom Pain Phantom Pain for Patients With Lower Limb Amputation
The primary goals of this pilot research project are a) to design and develop the a mixed reality based system for managing phantom pain and b) to evaluate the feasibility and preliminary functional outcomes of this system in a…
- Trial name
- MrMAPP (NCT04529083)
- Testing
- Mr. MAPP
- Where
- United States
- Volunteers
- 11 people
- Sponsor
- Dallas VA Medical Center
Amputation
Does Walking Performance Improve When Veterans With Leg Amputations Are Given Visual Feedback?
Previous studies suggest that Veterans with below the knee amputation using passive-elastic or powered prostheses have impaired physical function, which could increase the risk of osteoarthritis, leg/back pain, and…
- Trial name
- NCT03974945
- Testing
- Passive-elastic prosthetic foot, Powered ankle-foot prosthesis
- Where
- United States
- Volunteers
- 12 people, healthy volunteers welcome
- Sponsor
- VA Office of Research and Development
Amputation, Amputation; Traumatic, Leg, Lower
Clinical Outcomes With Passive MPKs vs. Powered Prosthetic Knees
The goal of this proposed project is to gather community-based data from the K4-level Transfemoral Amputee (TFA) population to aid in evidence-based prescription of powered prosthetic knees (i.e., choosing the right device to…
- Conditions
- Amputation, Amputation; Traumatic, Leg, Lower, Limb; Absence, Congenital, Lower, Prosthesis User
- Trial name
- NCT05267639
- Testing
- Power Knee
- Where
- 2 sites in United States
- Volunteers
- 13 people, healthy volunteers welcome
- Sponsor
- Liberating Technologies, Inc.
Lower Limb Amputation Above Knee (Injury)
Comparative Effectiveness Between Microprocessor Knees and Non-Microprocessor Knees
This study will assess if the functional performance and musculoskeletal outcome of transfemoral amputees are improved after receiving a Microprocessor Knee (MPK) compared to a Non-Microprocessor Knees (NMPK).
- Trial name
- MPK-AOPA (NCT02240186)
- Testing
- Microprocessor Knee (MPK), Non-Microprocessor Knee (NMPK)
- Where
- United States
- Volunteers
- 50 people
- Sponsor
- Mayo Clinic
Peripheral Vascular Diseases, Hyperglycaemia (Diabetic)
Peripheral Nerve Blocks for Above-the-knee Amputations
Surgery performed with nerve blocks and sedation may be safer and provide better pain control compared to general anesthesia and opioid therapy in high-risk patient populations such as elderly and troubled with peripheral…
- Conditions
- Peripheral Vascular Diseases, Hyperglycaemia (Diabetic), Hypertension, Coronary Artery Disease
- Trial name
- NCT03404180
- Testing
- Peripheral nerve block, Intravenous Sedatives, Lateral femoral cutaneous nerve blocks
- Where
- United States
- Volunteers
- 30 people
- Sponsor
- University of Florida
Trauma
Investigating Outcomes of Lower Limb Trauma
This is an observational study, which aims to firstly develop a sensor-based objective mobility assessment. This will then be used to profile and compare the outcomes of patients who undergo amputation with those who have limb…
- Trial name
- NCT01691950
- Where
- United Kingdom
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Imperial College London