Clinical trials: Lower Extremity Amputation
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, Prosthesis User
Lower Limb Prostheses for Individuals Who Carry Infants, Toddlers, and Other Loads
The aim of this research is to identify the prosthetic foot that results in improved walking performance when individuals with lower limb amputation carry infants, toddlers, or other loads.
- Trial name
- NCT07159490
- Testing
- Standard-of-care prosthetic foot, Standard-of-care prosthetic foot with heel-stiffening wedge, Standard-of-care prosthetic foot of one category greater stiffness
- Where
- United States
- Volunteers
- 13 people
- Sponsor
- VA Puget Sound Health Care System
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), Lower Limb Amputation Above Knee (Injury)
Feasibility Study to Evaluate a New Energy Storage and Return Prosthetic Foot
A prospective, interventional, multicenter pilot study to characterize differences in performance and patient reported outcomes between the Taleo, Proflex XC, and the new Revo prosthetic foot.
- Conditions
- Lower Limb Amputation Below Knee (Injury), Lower Limb Amputation Above Knee (Injury), Lower Limb Amputation Knee
- Trial name
- NCT04239222
- Testing
- Revo-M, Taleo, Proflex XC
- Where
- 4 sites in United States
- Volunteers
- 27 people
- Sponsor
- Otto Bock Healthcare Products GmbH
Amputation Stump, Amputation
Moisture Management Liner At-Home Evaluation
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 unbreathable and non-thermally conductive materials that can create a warm…
- Conditions
- Amputation Stump, Amputation, Amputees, Lower Limb Deformity
- Trial name
- NCT05124873
- Testing
- Moisture Management Liner
- Where
- United States
- Volunteers
- 1 people
- 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
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
Amputation, Diabetes
Vacuum Suspension: Effects on Tissue Oxygenation, Activity and Fit
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.
- Conditions
- Amputation, Diabetes, Leg Injuries, Traumatic Amputations
- Trial name
- NCT00117793
- Testing
- Total Surface Bearing Suction Socket, Vacuum assisted socket system
- Where
- United States
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- US Department of Veterans Affairs
Amputation, Amputation; Traumatic, Leg, Lower
A Comparative Assessment of Transfemoral Prosthetic Sockets
The objective of the proposed work is to enhance understanding of the potential benefits of adjustable sockets and inform clinical decision making.
- Trial name
- NCT04038580
- Testing
- Laminated Socket, Quatro, Infinite Socket
- Where
- 2 sites in United States
- Volunteers
- 29 people
- Sponsor
- University of Michigan
Amputation, Prosthesis User
Shared Decision Making Aid for Prosthetic Design
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.
- Trial name
- D-MAP (NCT04536025)
- Testing
- Qualitative focus group interviews, Qualitative semi-structured interviews
- Where
- United States
- Volunteers
- 66 people
- Sponsor
- University of Colorado, Denver
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
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.
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
Diabetes Mellitus, Leg Injuries
Prosthetic Components and Stability in Amputee Gait
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.
- Conditions
- Diabetes Mellitus, Leg Injuries, Traumatic Amputation
- Trial name
- NCT00167778
- Testing
- Transverse plane rotation adaptor pylon, Rigid pylon
- Where
- United States
- Volunteers
- 12 people, healthy volunteers welcome
- Sponsor
- US Department of Veterans Affairs
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
Amputation, Amputation; Traumatic, Leg, Lower
Socket Cooling Effectiveness Take Home 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, Amputation; Traumatic, Leg, Lower, Amputation Stump, Limb; Absence, Congenital, Lower
- Trial name
- NCT04484805
- Testing
- ICE Condition
- Where
- 2 sites in United States
- Volunteers
- 12 people, healthy volunteers welcome
- Sponsor
- Liberating Technologies, Inc.
Amputation, Diabetes Mellitus
Dysvascular Amputation Self-Management of Health
The purpose of this study is to determine if walking biobehavioral intervention improves physical activity after dysvascular lower limb amputation.
- Conditions
- Amputation, Diabetes Mellitus, Peripheral Artery Disease
- Trial name
- DASH (NCT04083456)
- Testing
- Walking Biobehavioral Intervention, Attention Control
- Where
- United States
- Volunteers
- 35 people
- Sponsor
- University of Colorado, Denver
Amputation, Surgical, Amputation, Traumatic
Cryoanalgesia to Treat Phantom Limb Pain Following Above-Knee Amputation
When a limb is severed, pain perceived in the part of the body that no longer exists often develops and is called "phantom limb" pain.
- Conditions
- Amputation, Surgical, Amputation, Traumatic, Phantom Limb Pain, Phantom Pain Following Amputation of Lower Limb
- Trial name
- NCT06071715
- Testing
- ACTIVE cryoneurolysis
- Where
- United States
- Volunteers
- 12 people
- Sponsor
- University of California, San Diego
Lower Extremity Amputation
Community Walking Trials: Comparing Prosthetic Feet
The purpose of the study is to obtain performance measurements and participant feedback about use of an investigational prosthetic foot compared to the participant's usual prosthetic foot.
- Trial name
- NCT03703232
- Testing
- Investigational prosthetic foot
- Where
- United States
- Volunteers
- 31 people
- Sponsor
- University of Washington
Amputation; Postoperative, Sequelae
Hyperbaric Oxygen and Outcome After Below Knee Amputations
This study is being conducted to assess the utility of hyperbaric oxygen as an adjunctive treatment to reduce postoperative complications.
- Trial name
- NCT04717557
- Testing
- Hyperbaric Oxygen
- Where
- United States
- Volunteers
- 4 people
- Sponsor
- Duke University