Clinical trials: Amputations
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
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
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
Prosthesis User, Amputation
Basic Mobility and Balance Performance of Low Active Transfemoral Prosthesis Users With a Powered Prosthetic Knee
This was a prospective case series design investigation with 6 prosthesis user subjects. Subjects performed the Timed up and go (TUG) test and the two minute walk test (2MWT) along with some activities of daily living (ADL), on…
- Trial name
- NCT04799145
- Testing
- Investigational device, Prescribed device
- Volunteers
- 6 people
- Sponsor
- Össur Iceland ehf
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
Diabetes Mellitus, Critical Limb Ischemia
N-Acetyl-Cysteine (NAC) for Healing of Amputation Stumps in the Setting of Diabetes
In this pilot clinical study the investigators propose to conduct a prospective, randomized, double-blinded, placebo-controlled clinical trial for 30 days for participants with critical limb ischemia (CLI) who undergo a major…
- Conditions
- Diabetes Mellitus, Critical Limb Ischemia, Lower Limb Amputation Knee, Peripheral Arterial Disease
- Trial name
- NCT03253328
- Testing
- Active Arm N-acetyl cysteine (NAC)
- Where
- United States
- Volunteers
- 33 people
- Sponsor
- Washington University School of Medicine
Diabetic Foot, Diabetic Ulcer of Left Foot
Crossing the Divide: Piloting Integrated Care to Reduce Amputations Among Rural Patients With Diabetic Foot Ulcers
This project directly addresses the escalating national rate of major (above-ankle) amputations due to diabetic foot ulcers; it focuses on rural patients, who face 37% higher odds of major amputation compared to their urban…
- Conditions
- Diabetic Foot, Diabetic Ulcer of Left Foot, Diabetic Ulcer of Right Foot, Amputation
- Trial name
- NCT05203471
- Testing
- integrated care model
- Where
- United States
- Volunteers
- 131 people
- Sponsor
- University of Wisconsin, Madison
Prostheses, Upper Limb Amputation Below Elbow
Wireless Prosthetic Control Effectiveness Study
The goal of this proposed project is to evaluate the effectiveness of our novel wireless electrode system, which the investigators refer to as the Asterisk system, on transradial prosthesis users.
- Trial name
- NCT06821412
- Testing
- ASTERISK System, Wired Configuration
- Where
- United States
- Volunteers
- 4 people
- Sponsor
- Liberating Technologies, Inc.
Mastectomy, Upper Limb Amputation Below Elbow
Cryoanalgesia to Prevent Acute and Chronic Pain Following Surgery: A Randomized, Double-Masked, Sham-Controlled Study
The ultimate objective of the proposed line of research is to determine if cryoanalgesia is an effective adjunctive treatment for pain in the period immediately following various painful surgical procedures; and, if this…
- Conditions
- Mastectomy, Upper Limb Amputation Below Elbow, Upper Limb Amputation Above Elbow, Lower Limb Amputation Below Knee
- Trial name
- NCT03578237
- Testing
- Cryoneurolysis (active)
- Where
- United States
- Volunteers
- 99 people
- Sponsor
- University of California, San Diego
Prosthesis User, Amputation
An Investigation on Function and Performance of a New Microprocessor Controlled Prosthetic Knee
This investigation aims to compare the functional performance of a new passive microprocessor-controlled Prosthetic Knee to subjects usual microprocessor-controlled prosthetic knee.
- Trial name
- NCT05523349
- Testing
- NAVii
- Where
- 4 sites in United States, Iceland
- Volunteers
- 14 people
- Sponsor
- Össur Iceland ehf
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.
Amputation
Measures of Gait Efficiency of Three Multi-Axial, Vertical Shock and Energy Storing-Return Prosthetic Feet During Simple & Complex Mobility Activities
Many service members suffering major limb amputation(s) during active duty seek to return to active duty. The purpose of this study is to determine if biomechanic and/or bioenergtic differences exist between popular…
- Trial name
- NCT01404559
- Testing
- Ossur Variflex prosthetic foot, Ossur Ceterus prosthetic foot, Endolite Elite Blade prosthetic foot
- Where
- United States
- Volunteers
- 28 people, healthy volunteers welcome
- Sponsor
- University of South Florida
Transfemoral Amputation, Unilateral Traumatic Amputation of Leg at or Above Knee
Functional Outcomes in Dysvascular Transfemoral Amputees
In older adults, poor circulation in the lower extremities leads to serious health complications including limb loss. In addition, individuals with dysvascular disease also suffer from other co-morbidities like diabetes, coronary…
- Trial name
- CLEG (NCT01537211)
- Testing
- C leg compared to subject's mechanical leg (Otto Bock)
- Where
- United States
- Volunteers
- 10 people
- Sponsor
- Shirley Ryan AbilityLab
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
Pain Management
A Non-invasive Intervention (BreEStim) for Management of Phantom Limb Pain (PLP) After Limb Amputation (Experiment 1)
The purpose of this study is to compare the effectiveness of innovative intervention of breathing controlled electrical stimulation (BreEStim) and conventional electrical stimulation (EStim) in management of neuropathic phantom…
- Trial name
- NCT04750525
- Testing
- BreEStim, EStim
- Where
- United States
- Volunteers
- 15 people
- Sponsor
- The University of Texas Health Science Center, Houston
Prosthesis User, Amputation
Clinical Investigation (Beta) of Power Knee Mainstream - Dynamic
Prospective two group cross over investigation, comparing the investigational device (Power Knee, a powered microprocessor controlled prosthetic knee) and subjects prescribed microprocessor prosthetic knee (MPK).
- Trial name
- NCT04787627
- Testing
- Power Knee
- Where
- 2 sites in United States
- Volunteers
- 17 people
- Sponsor
- Össur Iceland ehf
Amputation; Traumatic, Arm, Upper
Teleoperation Experimental Comparison With Able-bodied Subjects
To compare the use of the semi-autonomous control algorithm (condition 1) with the standard of care myoelectric system used with the TASKA prosthetic hand (condition 2).
- Trial name
- NCT05048394
- Testing
- Semi-autonomous myoelectric control algorithm, Standard-of-care myoelectric control algorithm
- Where
- United States
- Volunteers
- 11 people, healthy volunteers welcome
- Sponsor
- Point Designs
Amputation, Diabetes Mellitus, Type 2
Physical Activity Behavior Change for Older Adults After Dysvascular Amputation
This pilot study will use mobile-health technology to deliver an intervention designed for lasting physical activity behavior change.
- Conditions
- Amputation, Diabetes Mellitus, Type 2, Peripheral Artery Disease
- Trial name
- PABC (NCT02738086)
- Testing
- Physical Activity Behavior Change (PABC)
- Where
- United States
- Volunteers
- 31 people
- Sponsor
- VA Office of Research and Development
Postoperative Pain, Acute
Pulsed Shortwave Therapy for Postoperative Analgesia
Pulsed shortwave (radiofrequency) therapy is a possible method of pain control involving the application of electromagnetic energy (also termed pulsed electromagnetic fields).
- Trial name
- NCT05796583
- Testing
- Active Pulsed Shortwave Treatment
- Where
- United States
- Volunteers
- 70 people
- Sponsor
- University of California, San Diego
Traumatic Amputation of Arm
Interface Kinematics of Transhumeral Prosthetic Sockets Using XROMM
The purpose of this pilot study was to conduct a head-to-head comparison of two designs for transhumeral level upper limb prosthetic sockets: a traditional socket design and a socket design hypothesized to provide greater…
- Trial name
- NCT01546675
- Testing
- Skeletal Stabilization
- Where
- 2 sites in United States
- Volunteers
- 2 people
- Sponsor
- US Department of Veterans Affairs