Clinical trials: Lower Extremity Amputation
Lower Limb Amputation Below Knee (Injury)
Comprehensive Evaluation of the Passive Talaris Demonstrator
The passive Talaris Demonstrator (TD) is developed in continuation of previous prototypes. The main goal of the experiment is to evaluate the effectiveness of TD during daily activities.
- Trial name
- NCT05127993
- Testing
- Passive Talaris Demonstrator
- Where
- Belgium
- Volunteers
- 8 people, healthy volunteers welcome
- Sponsor
- Vrije Universiteit Brussel
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
Lower Limb Amputation
Transtibial Amputee Balance Training: A Randomised Controlled Trial
Lower limb amputees have reduced joint mobility and strength which negatively influence an individual's ability to maintain balance.
- Trial name
- NCT02572011
- Testing
- Home-based Games Console Balance Training
- Where
- 2 sites in United Kingdom
- Volunteers
- 2 people, healthy volunteers welcome
- Sponsor
- Nottingham Trent University
Behavior, Amputation
Self-Management for Amputee Rehabilitation Using Technology.
Lower Limb Amputations (LLAs) are a substantial burden on the Canadian health services with nearly 50,000 cases reported between 2006 and 2011.
- Conditions
- Behavior, Amputation, Lower Limb Amputation Above Knee (Injury), Lower Limb Amputation Below Knee (Injury)
- Trial name
- SMART (NCT04953364)
- Testing
- SMART, Control
- Where
- Canada
- Volunteers
- 82 people, healthy volunteers welcome
- Sponsor
- University of British Columbia
Amputation, Traumatic, Traumatic Amputation of Lower Extremity
What is the Optimal Stiffness and Height of a Running-specific Prosthesis?
The proposed study aims to characterize the effects of running-specific leg prosthetic stiffness and height during on performance during running and sprinting to optimize running-specific prosthesis prescription.
- Conditions
- Amputation, Traumatic, Traumatic Amputation of Lower Extremity, Wounds and Injuries
- Trial name
- NCT02318979
- Testing
- Otto Bock prosthesis, Ossur prosthesis, Freedom Innovations prosthesis
- Where
- United States
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- VA Eastern Colorado Health Care System
Lower-Limb Amputation
Motorized Prostheses for Lower-limb Amputees
The investigators will assess biomechanical and functional mobility outcomes in individuals with unilateral, above-knee amputations using different knee/ankle configurations of a lightweight powered prosthesis and different…
- Trial name
- NCT07486063
- Testing
- Powered and passive lower limb prosthesis and control
- Where
- United States
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- University of Utah
Lower Limb Amputation
Evaluation of Limb Health Associated With a Prosthetic Vacuum Socket System
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
- NCT01839123
- Testing
- Prosthetic Suction or Pin Socket, Prosthetic LimbLogic Vacuum Socket
- Where
- 2 sites in United States
- Volunteers
- 10 people, healthy volunteers welcome
- Sponsor
- Ohio Willow Wood
Lower Limb Amputation
A Pilot RCT to Investigate the Use of a Home-based Nintendo Wii Program for Rehabilitation in Older Adults With Lower Limb Amputation
This is a pilot randomized controlled trial to assess the feasibility of a home-based Nintendo Wii Fit program (Wii.n.Walk) to improve walking capacity in older adults with a lower limb amputation.
- Trial name
- NCT01715662
- Testing
- Wii.n.Walk, Wii Big Brain
- Where
- 3 sites in Canada
- Volunteers
- 28 people, healthy volunteers welcome
- Sponsor
- University of British Columbia
Diabetic Foot Infection, Osteomyelitis
A Clinical Trial Testing the Efficacy of PDT in Preventing Amputation in Diabetic Patients
The feet of diabetic patients continue to be an important problem in medicine. In general, patients with diabetic foot have some sort of amputation, especially in underserved populations.
- Conditions
- Diabetic Foot Infection, Osteomyelitis, Photo Antimicrobial Chemotherapy
- Trial name
- NCT03380403
- Testing
- PDT, Ciprofloxacin
- Volunteers
- 34 people, healthy volunteers welcome
- Sponsor
- Faculdade de Medicina do ABC
People With Lower Limb Amputation That Are Ambulatory
Assessment of Socket Shapes Made by Central Fabrication Facilities
Quality and accuracy of prosthetic sockets manufactured by central fabrication facilities may be lacking. Poor quality manufacturing can be detrimental to socket fit in amputees and may require more work by prosthetists to…
- Trial name
- NCT01245504
- Testing
- Assessed for socket fit
- Where
- United States
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- University of Washington
Arthroplasty Complications, Amputation
Clinical Trial Comparing Negative Pressure Wound Therapy and Standard Dry Dressings
Negative pressure dressings are currently widely used in wound management. Their use is gradually being extended to surgical scars.
- Conditions
- Arthroplasty Complications, Amputation, Prosthesis-Related Infections
- Trial name
- BERLYTZ (NCT04520841)
- Testing
- Prevena TM, Dry dressing
- Where
- Switzerland
- Volunteers
- 200 people, healthy volunteers welcome
- Sponsor
- University of Lausanne Hospitals
Diabetic Foot, Lower Limb Wound
Diabetic Foot Care and Limb Preservation Pathway: Developmental Evaluation Study
University Health Network (UHN), working together with local primary care practitioners, patients, and community healthcare services is developing a Diabetic Foot Care and Limb Preservation Care pathway.
- Conditions
- Diabetic Foot, Lower Limb Wound, Diabetes, Amputation
- Trial name
- NCT05446337
- Testing
- Open-Ended Semi-Structured Interview
- Volunteers
- 70 people, healthy volunteers welcome
- Sponsor
- University Health Network, Toronto
Ambulation With the "Take Home" or Passive Prosthesis, Ambulation With the Motorized Prosthesis in the "Off" Configuration
Investigation of Motorized Lower-limb Prostheses
The goal of this clinical trial is to learn if a motorized prosthesis can improve mobility in individuals with amputation. The main question it aims to answer is: Does motorized prosthesis improve ambulation speed, balance…
- Conditions
- Ambulation With the "Take Home" or Passive Prosthesis, Ambulation With the Motorized Prosthesis in the "Off" Configuration, Ambulation With the Motorized Prosthesis in the "Transparent" Condition, Ambulation With the Motorized Prosthesis in the "Powered" Condition
- Trial name
- NCT07584707
- Testing
- Passive prosthesis, Motorized prosthesis
- Where
- United States
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- Northern Arizona University
Lower Limb Amputation
Uses of Phantom Sensations Induced by Global and Local Modifications of the Prosthetic Socket as Somatosensory Feedback During Walking in Lower Limb Amputees
Following lower-limb amputation, the loss of somatosensory information from the missing limb renders walking less automatic, more cognitively demanding, and often asymmetric, which can lead to secondary pathologies.
- Trial name
- PhantomWalk (NCT07191795)
- Testing
- Gait analysis, Mapping of referred sensations., Evaluation of the effects of socket modifications on phantom sensations and walking
- Where
- France
- Volunteers
- 248 people, healthy volunteers welcome
- Sponsor
- Union de Gestion des Etablissements des Caisses d'Assurance Maladie - Nord Est
Lower Limb Amputation Below Knee, Diabetes (DM)
Skin Temperature Perception and Prosthetic Thermoregulation
To protect against excessive body temperatures, local thermoregulatory mechanisms include temperature sensory nerves (responsive to warm or cool stimuli) and vasomotors (muscles that constrict or dilate blood vessels).
- Conditions
- Lower Limb Amputation Below Knee, Diabetes (DM), Skin Temperature Change, Vascular Reactivity
- Trial name
- NCT07215442
- Testing
- Warming stimulus starting at 30 C initial temperature, Warming stimulus starting at 32 C initial temperature, Warming stimulus starting at 34 C initial temperature
- Where
- United States
- Volunteers
- 56 people, healthy volunteers welcome
- Sponsor
- VA Puget Sound Health Care System
Acquired Absence of Lower Limb, Scar Condition and Fibrosis of the Skin
LASER Pilot Project
Veterans who use prosthetic limbs commonly suffer from skin problems such as scars that create discomfort and pain to the point that wearing the prosthesis is no longer tolerable.
- Trial name
- LASER (NCT05966636)
- Testing
- Fractional CO2 Laser Ablative Resurfacing
- Where
- 2 sites in United States
- Volunteers
- 10 people, healthy volunteers welcome
- Sponsor
- VA Office of Research and Development
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.
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
Lower Limb Amputation Below Knee (Injury)
Human-Prosthetic Interaction: Brain & Technology After Lower-Limb Loss
This study evaluates brain neuroplasticity and functional performance in people with unilateral lower limb amputation.
- Trial name
- HumanIT (NCT05818410)
- Testing
- Prosthetic device (Lunaris), No prosthetic device, Prosthetic device (Sach foot)
- Where
- Belgium
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- Vrije Universiteit Brussel
Lower Limb Amputation Above Knee (Injury)
Analyzing Stump-socket Interface Pressure to Improve Gait in Above-knee Amputee
This study aims at evaluating the relation between quality of the interface between the stump and the prosthesis, and the quality of gait in above-knee amputees.
- Trial name
- NCT01848964
- Testing
- Clinical and instrumented measurements
- Where
- France
- Volunteers
- 80 people, healthy volunteers welcome
- Sponsor
- University Hospital, Grenoble