Clinical trials: Limb Amputation
Lower Limb Loss
Musculoskeletal Measurements in Transfemoral Amputees
The aim of this study was to identify posture asymmetries in transfemoral amputees utilizing clinical evaluation measures. The purposes of this investigation were: 1) to measure the limb length indirectly to determine the…
- Trial name
- NCT00909922
- Where
- United States
- Volunteers
- 80 people, healthy volunteers welcome
- Sponsor
- Miami VA Healthcare System
Wounded Warrior, Limb Shortening
AMP30: Autologous Fat Grafting, Amputation Sites Pain: Randomized
We propose a prospective, randomized clinical study to assess the efficacy of minimally invasive autologous fat transfer addressing pain and poor prosthetic fit at amputation sites.
- Conditions
- Wounded Warrior, Limb Shortening, Amputation
- Trial name
- AMP30 (NCT02076022)
- Testing
- Enhanced Fat Grafting, Standard fat graft
- Where
- United States
- Volunteers
- 10 people
- Sponsor
- J. Peter Rubin, MD
Traumatic Amputation of Lower Extremity
Intraosseous Transcutaneous Amputation Prosthesis
Direct Skeletal Fixation of Prosthetic Limbs Following Trans-Femoral Amputation - Study of an Intraosseous Transcutaneous Amputation Prosthesis (ITAPTM).
- Trial name
- (ITAP) (NCT02491424)
- Testing
- Direct skeletal fixation of ITAP to lower limb amputees.
- Where
- 2 sites in United Kingdom
- Volunteers
- 20 people
- Sponsor
- Stryker Orthopaedics
Amputation, Prosthesis User
Optimizing Prosthetic Prescription to Mitigate the Effects of Perspiration
The specific aim of this research is to compare three clinically available liners, each intended to address problems of residual limb perspiration, with the as-prescribed liner of lower limb prosthesis user and determine their…
- Trial name
- NCT07024342
- Testing
- Liner perforated with very small diameter holes, Liner perforated with somewhat larger diameter holes, Liner-liner
- Where
- United States
- Volunteers
- 180 people
- Sponsor
- VA Puget Sound Health Care System
Lower Limb Amputation Below Knee (Injury)
R21: An Easy-to-use, iNtelligent, Affordable LinEr (ENABLE) System for Socket Fit Assessment
Lower limb amputees (LLA) rely on their prosthetic legs to remain active and lead an independent life. For most LLAs, a well-fitted prosthetic socket is the only option to interface with their prosthetic leg, however, it is a…
- Trial name
- ENABLE (NCT05425810)
- Testing
- Apply ENABLE sensing pad, Insert small pads at pressure tolerant locations
- Where
- United States
- Volunteers
- 3 people
- Sponsor
- North Carolina State University
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
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
Lower Extremity Amputation
Impact of a Lower Extremity Amputation Pathway Protocol in Dysvascular Patients
The LEAP protocol is a prospective cohort study of dysvascular patients designed to determine whether implementation of a multi-disciplinary lower extremity amputation protocol in the peri-operative period can shorten…
- Trial name
- NCT03592316
- Testing
- Lower Extremity Amputation Pathway
- Where
- United States
- Volunteers
- 11 people
- Sponsor
- University of California, San Francisco
Transtibial Amputation
Evaluation of a Modified Running-specific Prosthetic Foot
The goal of this study is to evaluate endurance, walking performance, mobility, and perceived exertion of transtibial prosthesis users (i.e., study participants) walking with a conventional energy storing prosthetic foot (ESF)…
- Trial name
- NCT02440711
- Testing
- Energy storing foot (ESF), Modified running specific foot (mRSF)
- Where
- United States
- Volunteers
- 36 people
- Sponsor
- University of Washington
Upper Limb Amputation Below Elbow
Evaluation of a Multi-electrode Prosthesis Control System for Real-world Tasks Performance in Individuals With Upper Limb Transradial Amputation
This study tests how well the Phantom X prosthesis control system works. The system helps control a prosthetic hand using muscle signals from the arm. You'll wear a non-invasive version for one day in the clinic.
- Trial name
- EMPOWER (NCT07071584)
- Testing
- Cutaneous Prosthesis Control System
- Where
- 2 sites in United States
- Sponsor
- Phantom Neuro Inc.
Transfemoral Amputation, Limb Loss
A Biomechanical Evaluation of the Ossur Power Knee in Persons With Transfemoral Amputation
Microprocessor-controlled knees (MPKs) do not typically utilize motors to power joint rotation, but they automatically adjust resistance or damping in the joint to improve swing- and/or stance-phase control as appropriate for the…
- Conditions
- Transfemoral Amputation, Limb Loss, Limb Absence
- Trial name
- OPKTFA (NCT06218238)
- Testing
- Powered prosthetic knee joint, Conventional microprocessor-controlled prosthetic knee joint
- Where
- United States
- Volunteers
- 20 people
- Sponsor
- VA Office of Research and Development
Amputation, Artificial Limbs
Functional Performance Evaluation of NU-FlexSIV Socket
The overall objective of this study is to provide a more comfortable and functional prosthetic socket for persons with transfemoral amputation that will ultimately improve their quality of life.
- Trial name
- NCT02678247
- Testing
- Northwestern University Flexible Sub-Ischial Vacuum Socket, Ischial Containment Socket
- Where
- 3 sites in United States
- Volunteers
- 30 people
- Sponsor
- Northwestern University
Traumatic Amputation of Lower Extremity, Cartilage Degeneration
The Assessment of Talar Cartilage in Patients With Unilateral Traumatic Transtibial Amputation
Increased risk of osteoarthritis (OA) has been previously demonstrated in patients with lower limb amputation. Although there are many studies on knee joint of intact limb of amputees in the literature, the number of studies on…
- Trial name
- NCT04486534
- Testing
- Musculoskeletal ultrasound
- Where
- Turkey (Türkiye)
- Volunteers
- 72 people, healthy volunteers welcome
- Sponsor
- Gaziler Physical Medicine and Rehabilitation Education and Research Hospital
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
Assessment of a Hybrid Pump for Vacuum Suspension of Prosthetic Sockets for Persons With Lower Limb Loss to Characterize the Effects of Added Movement on Socket-reaction Torques
Prostheses can be suspended from the amputated limb using a variety of techniques, such as straps and suction. Suspending the prosthesis by creating a vacuum between the prosthetic socket and limb using a pump has benefits over…
- Trial name
- HIPPI (NCT04230512)
- Testing
- Pump prototype
- Where
- United States
- Volunteers
- 12 people
- Sponsor
- VA Office of Research and Development
Ischemia, Blood Circulation Disorder
Early Discovery of Ischemia After Replantation Surgery of the Extremities
Investigators will test if changes in CO2 is detected postoperatively in ischemic tissue in a replanted extremity of a traumatically amputated upper or lower extremity.
- Conditions
- Ischemia, Blood Circulation Disorder, Carbon Dioxide, Biosensing Techniques
- Trial name
- EDIR (NCT05297266)
- Testing
- IscAlert
- Where
- Norway
- Volunteers
- 60 people
- Sponsor
- Oslo University Hospital
Amputation, Transtibial Amputation - Unilateral
Influence of Prosthetic Foot Stiffness on Transtibial Osseointegrated Bone-Anchored Limb Outcomes
A clinical trial utilizing cross-over study design in which individuals with transtibial amputation using either a bone-anchored limb or standard socket prosthesis will perform activities of daily living with varying prosthetic…
- Conditions
- Amputation, Transtibial Amputation - Unilateral, Bone Anchored Devices, Osseointegration
- Trial name
- TBAL (NCT07263945)
- Testing
- As-prescribed prosthetic foot stiffness, A prosthetic foot that is two prosthetic foot stiffness categories stiffer than the stiffness of the as-prescribed prosthetic foot, A prosthetic foot that is two prosthetic foot stiffness categories softer than the stiffness of the as-prescribed prosthetic foot
- Where
- United States
- Volunteers
- 60 people
- Sponsor
- University of Colorado, Denver
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
Lower Limb Amputation
Exploratory Functional Assessment After Lower Limb Amputation: Locomotion, Balance, Energy Performance and Strategies for Adapting to Orthopaedic Devices
The general aim of this exploratory study is therefore to investigate and quantify the functional capacities of patients with lower limb amputations (transtibial and transfemoral), with no change in their management, and to…
- Trial name
- AMILOCO (NCT07094074)
- Testing
- Walk tests, Functional testing, Balance analysis
- Where
- France
- Volunteers
- 100 people
- Sponsor
- Centre Hospitalier Universitaire Dijon
Phantom Limb Pain, Stump Neuralgia
Cryolesion in Treatment of Phantom Limb Pain
Assessment of pain intensity on the NRS. Assessment of the quality of life by SF-36 and AIS. Diagnostic/prognostic nerve block with 5 ml of 2% lidocaine under real-time ultrasound control with confirmation of the correct position…
- Conditions
- Phantom Limb Pain, Stump Neuralgia, Pain, Phantom
- Trial name
- NCT03415360
- Testing
- cryoablation
- Where
- Poland
- Volunteers
- 50 people
- Sponsor
- Military Institute od Medicine National Research Institute