Clinical trials: Amputation
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
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
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
Amputation
Optimizing Prosthetic and Bicycle Fit for Veterans With Transtibial Amputations
Bicycling is a promising form of low-impact exercise that could prevent/treat Type 2 diabetes. However, Veterans with transtibial amputations (TTAs) may not effectively utilize bicycling for rehabilitation and exercise due to…
- Trial name
- BestBikeFit (NCT03828331)
- Testing
- Prosthetic/Bicycle Configuration
- Where
- United States
- Volunteers
- 12 people, healthy volunteers welcome
- Sponsor
- VA Office of Research and Development
Lower Limb Amputation Above Knee (Injury)
Comparative Effectiveness Between Microprocessor Knees and Non-Microprocessor Knees
This study will assess if the functional performance and musculoskeletal outcome of transfemoral amputees are improved after receiving a Microprocessor Knee (MPK) compared to a Non-Microprocessor Knees (NMPK).
- Trial name
- MPK-AOPA (NCT02240186)
- Testing
- Microprocessor Knee (MPK), Non-Microprocessor Knee (NMPK)
- Where
- United States
- Volunteers
- 50 people
- Sponsor
- Mayo Clinic
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
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
Amputation, Phantom Limb
Naval Medical Center San Diego (NMCSD) - Ambulatory Continuous Peripheral Nerve Blocks for Treatment of Post-Amputation Phantom Limb and Stump Pain
The purpose of this research study is to determine if putting local anesthetic-or numbing medication-through one or two tiny tube(s) placed next to the nerves that go to an amputated limb will decrease phantom limb and/or stump…
- Conditions
- Amputation, Phantom Limb, Stump Pain
- Trial name
- NCT00768248
- Testing
- perineural ropivacaine
- Where
- United States
- Volunteers
- 2 people
- Sponsor
- University of California, San Diego
Amputation Wound, Traumatic Amputation of Toe
Longitudinal Study of Weight Change Following Lower Limb Amputation
The purpose of this study is to assess weight change in a population of Veterans with amputations. Little is known about the how weight changes following an amputation.
- Conditions
- Amputation Wound, Traumatic Amputation of Toe, Dysvascular Amputation of Lower Limb
- Trial name
- NCT00932399
- Where
- United States
- Volunteers
- 4,549 people, healthy volunteers welcome
- Sponsor
- VA Office of Research and Development
Amputation, Amputation; Traumatic, Hand
Dexterous Partial Hand Prosthesis Outcomes
Liberating Technologies, Inc. (LTI) has developed a dexterous prosthetic fingertip that will be fit onto an i-Digits™ partial hand prosthesis and allow for an additional fine grasp.
- Conditions
- Amputation, Amputation; Traumatic, Hand, Limb; Absence, Congenital, Upper, Prosthesis User
- Trial name
- NCT05038566
- Testing
- Pointdexter
- Where
- 2 sites in United States
- Volunteers
- 4 people, healthy volunteers welcome
- Sponsor
- Liberating Technologies, Inc.
Critical Limb Ischemia, Peripheral Arterial Disease
Safety and Efficacy Study of Autologous Concentrated Bone Marrow Aspirate (cBMA) for Critical Limb Ischemia (CLI)
This trial will evaluate the safety and efficacy of concentrated bone marrow aspirate (cBMA) to prevent or delay major amputation and/or death in subjects with critical limb ischemia (CLI) due to severe peripheral arterial…
- Conditions
- Critical Limb Ischemia, Peripheral Arterial Disease, Peripheral Vascular Disease
- Trial name
- MOBILE (NCT01049919)
- Testing
- Bone marrow concentration device
- Where
- 25 sites in United States
- Volunteers
- 153 people
- Sponsor
- Zimmer Biomet
Amputation; Traumatic, Hand
Validation of User Needs of the Point Digit With Partial Hand Amputees
The objective of the device feasibility study will be to validate the user needs of the Point Digit system. This study will be a single group intervention model where one group of 5 partial hand amputees will be asked to perform…
- Trial name
- NCT04763278
- Testing
- Point Digit
- Where
- 2 sites in United States
- Volunteers
- 7 people
- Sponsor
- Point Designs
Prosthesis User, Amputation
An Investigation of Functional Improvements in the RHEO KNEE Compared to Hydraulic Microprocessor Controlled Knees (MPKs)
The aim of this study was to evaluate the mobility, perceived safety and functioning of unilateral transfemoral (TF) amputees using the Rheo Knee XC compared to their existing prosthetic knee (RHEO KNEE II, III or Genium, X2 or…
- Trial name
- NCT04023578
- Testing
- RHEO KNEE XC
- Where
- 4 sites in United States
- Volunteers
- 15 people
- Sponsor
- Össur Iceland ehf
Phantom Limb Pain, Residual Limb Pain
Pulsed Electromagnetic Fields for Post-Amputation Pain
Pulsed electromagnetic field therapy is a possible method of pain control involving the application of electromagnetic energy (also termed nonthermal, pulsed, shortwave radiofrequency therapy).
- Trial name
- NCT05392803
- Where
- United States
- Volunteers
- 14 people
- Sponsor
- University of California, San Diego
Amputation
Immediate Fit Using Innovative Technology Transtibial & Transfemoral Prosthesis
iFIT Prosthetics, LLC® created and commercialized a modular, immediate fit, fully adjustable, prosthetic system suitable for mass production using high strength injection molded polymer materials.
- Trial name
- NCT02886936
- Testing
- iFIT Transtibial Prosthesis, iFIT Transfemoral Prosthesis
- Where
- United States
- Volunteers
- 71 people
- Sponsor
- University of Pennsylvania
Traumatic Amputation of Arm
Home Study of an Advanced Upper Limb Prosthesis
The overall study objective is to examine the feasibility, acceptance, and benefits of home use of an advanced upper limb prosthetic device as well as the logistical support requirements utilized during 3 months of home usage.
- Trial name
- NCT01551420
- Testing
- Advanced upper limb prosthetic device IMU controlled, Advanced upper limb prosthetic EMG-PR controlled
- Where
- 4 sites in United States
- Volunteers
- 52 people
- Sponsor
- VA Office of Research and Development
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 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.
Transtibial Amputation
Effects of Shrinker Use on Healing and Volume
We expect subjects in the interventional groups, who wear shrinkers, to heal more quickly than control subjects who wear no shrinkers.
- Trial name
- NCT00693628
- Testing
- compression shrinker
- Where
- United States
- Volunteers
- 4 people
- Sponsor
- University of Oklahoma
Amputation of Lower Limb
Assessment of Safety and Performances of a 3D Printed Prosthetic Foot: A Pilot Study
A dynamic energy storage and return foot prosthesis is a type of prosthesis designed to mimic and restore the functionality and natural movement of the limb that has been amputated.
- Trial name
- NCT06938087
- Testing
- 3D printed prosthesis foot, Current prosthesis foot
- Where
- Italy
- Volunteers
- 3 people
- Sponsor
- Istituto Nazionale Assicurazione contro gli Infortuni sul Lavoro