Clinical trials: Lower Leg Amputations
Amputation, Lower Limb
Quantifying Bone and Skin Movement in the Residual Limb of Individuals With Transtibial Amputation Using Dynamic Stereo X-Ray
Individuals with lower extremity amputation are often challenged by complications that arise from poor prosthetic fit, including movement of the residual limb in the socket, known as pistoning.
- Trial name
- NCT05287646
- Testing
- Suction Suspension First, Elevated Vacuum Suspension First
- Where
- United States
- Volunteers
- 21 people
- Sponsor
- VA Office of Research and Development
Gait, Balance
Gait Stability of People With Lower-limb Amputations
The purpose of this study is to evaluate whether there are quantifiable differences in walking stability, as measured by the acceleration of the trunk or the variation in step length, between people with unilateral below-knee…
- Trial name
- NCT00915109
- Where
- Canada
- Volunteers
- 50 people, healthy volunteers welcome
- Sponsor
- Kim Parker
Critical Limb Ischemia, Peripheral Arterial Disease
ALD-301 for Critical Limb Ischemia, Randomized Trial
This study will treat patients with such severe lower leg ischemia or vascular compromise that they have pain at rest. The goal is to compare treatment of the patient's painful disorder by injecting cells into the calf of the leg…
- Conditions
- Critical Limb Ischemia, Peripheral Arterial Disease, Peripheral Vascular Disease
- Trial name
- CLI-001 (NCT00392509)
- Testing
- ALDH-br bone marrow cells vs. mononuclear bone marrow cells
- Where
- 5 sites in United States
- Volunteers
- 20 people
- Sponsor
- Aldagen
Amputation
Personalized Mobility Interventions Using Smart Sensor Resources for Lower-Limb Prosthesis Users
The goal of this research is to analyze data from smartphone-based and wearable sensors, using advanced machine-learning and data-mining techniques, and to combine this information with performance-based measures…
- Trial name
- NCT03930199
- Testing
- Needs-based intervention (physical, psychological, or both)
- Where
- 3 sites in United States
- Volunteers
- 66 people
- Sponsor
- Shirley Ryan AbilityLab
Lower Limb Amputation Above Knee (Injury)
Decoding Motion Planning Using Cortical Potentials
The team will investigate the user's intention to move by using cortical activity during a sit to stand movement performance in people with a transfemoral amputation and able-bodied individuals.
- Trial name
- NCT04325516
- Testing
- Daily activities
- Where
- Belgium
- Volunteers
- 10 people, healthy volunteers welcome
- Sponsor
- Vrije Universiteit Brussel
Diabetic Foot Ulcer
The Effect of Implementing a Limb Loss Prevention Program on Amputation Rates
The investigators plan to do a retrospective chart review on patients admitted to Parkland Hospital with diabetic foot infections, ulcers, and bone injuries from 2005 (5 years prior to the start of the diabetic limb preservation…
- Trial name
- NCT03978715
- Testing
- No intervention-retrospective study
- Where
- United States
- Volunteers
- 3,000 people
- Sponsor
- University of Texas Southwestern Medical Center
Amputation, Traumatic
Relationship Between Gait Variability and Sensation
Twenty individuals who were referred to receive physiotherapy will be participants of the study. Participants with lower limb loss will evaluate with the following assessment tools: Demographic datas; age, gender, height, body…
- Trial name
- NCT02934074
- Testing
- No intervention
- Volunteers
- 20 people
- Sponsor
- Hacettepe University
Diabetic Foot, Amputation
Pattern and Type of Amputation and Mortality Rate Associated With Diabetic Foot in Jeddah, Saudi Arabia: A Retrospective Cohort Study
This study explored the pattern and type of amputations performed on patients with diabetic foot who were admitted to our institution, as well as the 7-year mortality rate of patients with diabetic foot at the same institution.
- Trial name
- NCT05123157
- Testing
- NO intervention
- Where
- Saudi Arabia
- Volunteers
- 358 people
- Sponsor
- King Abdulaziz University
Diabetes, Foot Ulcer
Preventing Amputations by Tailored Risk-based Intervention to Optimize Therapy
The PATRIOT study will evaluate a risk-based personalized behavioral intervention to improve foot self-care, self-monitoring, and modifiable risks for amputation such as blood glucose, blood pressure and cholesterol in order to…
- Trial name
- PATRIOT (NCT02356757)
- Testing
- Personalized Behavioral Intervention, Current Best Practice
- Where
- United States
- Volunteers
- 406 people
- Sponsor
- VA Office of Research and Development
Amputation
A Prosthetic Foot Test-Drive Strategy for Improving Stability in Veterans With Leg Amputations
Objective/Hypotheses and Specific Aims: The first aim of this proposal is to determine the effects of commercial prosthetic feet of varying stiffness on stability and falls-related outcomes in Veterans with TTA.
- Trial name
- NCT05473065
- Testing
- Multiaxial Prosthetic Foot Emulator, Commercially available prosthetic feet
- Where
- 2 sites in United States
- Volunteers
- 46 people
- Sponsor
- Seattle Institute for Biomedical and Clinical Research
Lower Limb Amputation Below Knee (Injury)
Descriptive Study of Receptive Fields in Lower Limb Amputees
It has been observed that patients subjected to amputations develop so called receptive fields, which time of occurrence and localization over time are yet not examined systematically.
- Trial name
- NCT03348605
- Testing
- Phantom Stimulator, Cort X Sensorics, Spaichingen, Germany
- Where
- Switzerland
- Volunteers
- 35 people
- Sponsor
- Rehaklinik Bellikon
Amputation
Enhancing Motor Function in Individuals with Lower Limb Amputation
The overall goal of this research project is to investigate the effectiveness and the science of peer-based prosthetic skill training in individuals with leg amputation.
- Trial name
- NCT06638723
- Testing
- Balance and fall recovery training
- Where
- United States
- Volunteers
- 20 people
- Sponsor
- University of Nevada, Las Vegas
Amputation of Lower Limb Above Knee
Evaluation of Transfemoral Amputees When Transitioning From a Mechanical to a Microprocessor Prosthetic Knee
The central hypothesis of this proposal is that real-life benefits of microprocessor knees (MPK) are largely underappreciated because of the lack of sensitive and ecologically valid methods for evaluating motor performance.
- Trial name
- NCT03829202
- Testing
- Own mechanical knee, RheoKnee microprocessor prosthetic knee
- Volunteers
- 7 people
- Sponsor
- Methodist Rehabilitation Center
Amputation of Lower Extremity, All Causes
Gait and Energy Expenditure in Children With Lower Limb Amputation (MAPEDE)
In lower limb amputation, prosthetic gait has been shown to be particularly energy-intensive. While energy expenditure has been the focus of many studies in adult amputees, this area of research is less developed for paediatric…
- Trial name
- MAPEDE (NCT07076602)
- Testing
- Gait and energy expenditure
- Where
- 8 sites in France
- Volunteers
- 48 people
- Sponsor
- Rennes University Hospital
Critical Limb Ischemia, Critical Lower Limb Ischemia
PROMISE II: Percutaneous Deep Vein Arterialization for the Treatment of Late-Stage Chronic Limb-Threatening Ischemia
The LimFlow System is intended for endovascular, minimally invasive procedures in patients who have a clinical diagnosis of chronic limb-threatening ischemia and who have been determined to have no surgical or endovascular…
- Conditions
- Critical Limb Ischemia, Critical Lower Limb Ischemia, Peripheral Artery Disease, Peripheral Arterial Disease
- Trial name
- PROMISE (NCT03970538)
- Testing
- LimFlow System
- Where
- 21 sites in United States, Puerto Rico
- Volunteers
- 105 people
- Sponsor
- LimFlow, Inc.
Transtibial Amputation, Lower Limb Amputation Below Knee
Clinical Evaluation of the Access Socket Flexible Socket for Transtibial Prosthesis
Transtibial amputation significantly impacts patient autonomy and quality of life, primarily due to the limitations of conventional rigid sockets, which restrict comfort and joint range of motion.
- Trial name
- AS-TT (NCT07592325)
- Testing
- Access Socket (AS), Rigid Socket (RS)
- Where
- 5 sites in France
- Volunteers
- 25 people
- Sponsor
- Union de Gestion des Etablissements des Caisses d'Assurance Maladie - Nord Est
Lower Limb Amputation Above Knee (Injury), Lower Limb Amputation Knee
Reverse Innovation in Western Health Care: the ReMotion Prosthetic Knee.
Ambulatory mobility and function are important aspects in the quality of life of people with lower limb amputations and prostheses.
- Trial name
- NCT04700085
- Testing
- ReMotion Knee
- Where
- Netherlands
- Volunteers
- 9 people
- Sponsor
- Sint Maartenskliniek
Amputation of Lower Limb Above Knee, Amputee
Bio Leg: Advancing Mobility (BAM)
Following transfemoral amputation, regaining functional mobility, particularly the ability to navigate curbs, ramps, long distances, and the ability to stand is challenging and often unattainable.
- Conditions
- Amputation of Lower Limb Above Knee, Amputee, Amputation
- Trial name
- BAM (NCT07613502)
- Testing
- Bio Leg
- Where
- United States
- Volunteers
- 12 people
- Sponsor
- University of Florida
Amputation; Traumatic, Leg, Lower, Between Knee and Ankle
Comparison Between Three Types of Prosthetic Feet
One Solid Ankle Cushion Heel (SACH) and two Dynamic Elastic Response (DER) prosthetic feet will be tried six times in random order by the patient.
- Trial name
- ProSto (NCT03046394)
- Testing
- C-SACH, B-DER, A-DER
- Where
- Slovenia
- Volunteers
- 1 people
- Sponsor
- University Rehabilitation Institute, Republic of Slovenia
Amputation
Targeted Muscle Reinnervation Study (TMR)
The purpose of this study is to examine the effect of targeted muscle reinnervation on the outcomes of amputees at a level 1 trauma center.
- Trial name
- TMR (NCT05408520)
- Testing
- Targeted Muscle Reinnervation
- Where
- United States
- Volunteers
- healthy volunteers welcome
- Sponsor
- University of Arizona