Clinical trials: Amputation
Phantom Limb Pain
Mixed Reality Based System to Manage Phantom Pain Phantom Pain for Patients With Lower Limb Amputation
The primary goals of this pilot research project are a) to design and develop the a mixed reality based system for managing phantom pain and b) to evaluate the feasibility and preliminary functional outcomes of this system in a…
- Trial name
- MrMAPP (NCT04529083)
- Testing
- Mr. MAPP
- Where
- United States
- Volunteers
- 11 people
- Sponsor
- Dallas VA Medical Center
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.
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
Neuropathic Pain, Amputation
The SNAP Trial: SPRINT® Peripheral Nerve Stimulation for the Treatment of Neuropathic Post-Amputation Pain
The purpose of this study is to determine if pain can be relieved by delivering small amounts of electricity (called "electrical stimulation") to the nerves in an individual's amputated leg.This study will involve the use of a…
- Trial name
- SNAP (NCT03783689)
- Testing
- SPRINT Peripheral Nerve Stimulation (PNS) System
- Where
- 14 sites in United States
- Volunteers
- 38 people
- Sponsor
- SPR Therapeutics, Inc.
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
Amputation, Amputation; Traumatic, Leg, Lower
Clinical Outcomes With Passive MPKs vs. Powered Prosthetic Knees
The goal of this proposed project is to gather community-based data from the K4-level Transfemoral Amputee (TFA) population to aid in evidence-based prescription of powered prosthetic knees (i.e., choosing the right device to…
- Conditions
- Amputation, Amputation; Traumatic, Leg, Lower, Limb; Absence, Congenital, Lower, Prosthesis User
- Trial name
- NCT05267639
- Testing
- Power Knee
- Where
- 2 sites in United States
- Volunteers
- 13 people, healthy volunteers welcome
- Sponsor
- Liberating Technologies, Inc.
Transtibial Amputation
Metabolic Cost Savings for Transtibial Amputees Wearing the Controlled Energy Storage and Return (CESR) Foot
To determine if below-knee amputees will walk with better efficiency wearing a CESR foot which stores energy at heel strike and releases energy releases energy during push-off.
- Trial name
- NCT00494143
- Testing
- CESR Prosthetic Foot, typical prosthetic foot, standardized prosthetic foot
- Where
- United States
- Volunteers
- 7 people, healthy volunteers welcome
- Sponsor
- US Department of Veterans Affairs
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
Unilateral Traumatic Amputation, Amputation, Traumatic
Determining the Potential Benefit of Powered Prostheses
The goal of this research is to determine the effectiveness of a powered prosthesis compared to an unpowered prosthesis during short bouts of walking, extended periods of walking (to fatigue), and performance in the community.
- Trial name
- NCT02828982
- Testing
- Powered ankle prosthesis, Dynamic Response Foot
- Where
- United States
- Volunteers
- 12 people
- Sponsor
- Deanna H Gates
Peripheral Vascular Diseases, Hyperglycaemia (Diabetic)
Peripheral Nerve Blocks for Above-the-knee Amputations
Surgery performed with nerve blocks and sedation may be safer and provide better pain control compared to general anesthesia and opioid therapy in high-risk patient populations such as elderly and troubled with peripheral…
- Conditions
- Peripheral Vascular Diseases, Hyperglycaemia (Diabetic), Hypertension, Coronary Artery Disease
- Trial name
- NCT03404180
- Testing
- Peripheral nerve block, Intravenous Sedatives, Lateral femoral cutaneous nerve blocks
- Where
- United States
- Volunteers
- 30 people
- Sponsor
- University of Florida
Amputation
Junior LP Foot - Clinical Investigation Protocol
The purpose of the following study is of exploratory nature to provide design input for a prosthetic foot under development for children with lower limb loss, amputation or deficiency.
- Trial name
- NCT06156839
- Testing
- Prosthetic Foot
- Volunteers
- 13 people
- Sponsor
- Össur Iceland ehf
Amputation
Intent Recognition for Prosthesis Control
This work will focus on new algorithms for powered prostheses and testing these in human subject tests. Individuals with above knee amputation will walk with a robotic prosthesis and ambulate over terrain that simulates community…
- Trial name
- NCT05537792
- Testing
- Robotic Knee/Ankle Prosthesis
- Where
- United States
- Volunteers
- 10 people
- Sponsor
- Georgia Institute of Technology
Trauma
Investigating Outcomes of Lower Limb Trauma
This is an observational study, which aims to firstly develop a sensor-based objective mobility assessment. This will then be used to profile and compare the outcomes of patients who undergo amputation with those who have limb…
- Trial name
- NCT01691950
- Where
- United Kingdom
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Imperial College London
Post-Amputation Phantom Limb Pain
Cryoanalgesia to Treat Post-Amputation Phantom Limb Pain: A Department of Defense Funded Multicenter Study
When a limb is severed, pain perceived in the part of the body that no longer exists often develops and is called "phantom limb" pain.
- Trial name
- NCT03449667
- Testing
- Cryoneurolysis
- Where
- 6 sites in United States
- Volunteers
- 144 people
- Sponsor
- University of California, San Diego
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
Amputation, Limb Loss
Self-management to Improve Function Following Amputation
Lower extremity amputations are a significant cause of morbidity, mortality, loss of function and reduced quality of life. Self-management (defined as the process by which an individual adopts an active role in managing the…
- Trial name
- VETPALS (NCT02163811)
- Testing
- VETPALS, Individual Education Support Program
- Where
- 5 sites in United States
- Volunteers
- 182 people
- Sponsor
- VA Office of Research and Development
Lower Extremity Amputation
Pivot-Flex Foot: Optimal Coupling Ratio Between Transverse and Sagittal-plane Motions Using a Torsionally Adaptive Prosthesis for Individuals With Lower Limb Amputation
When prescribing a prosthetic foot, clinicians face a dizzying array of choices as more than 200 different prosthetic feet are available.
- Trial name
- NCT03532100
- Testing
- Torsionally adaptive prosthesis with 0:1 coupling ratio, Torsionally adaptive prosthesis with 1:6 coupling ratio, Torsionally adaptive prosthesis with 1:4 coupling ratio
- Where
- United States
- Volunteers
- 14 people
- Sponsor
- VA Office of Research and Development
Diabetes, Foot Ulcers
Evaluation of Negative Pressure Wound Therapy in the Treatment of DFUs Incl. Post Amputation Wounds.
Primary objective To assess wound healing and granulation tissue formation when using the NPWT system Secondary objectives To investigate the pain level at dressing removal To visually check exudate removal To investigate the…
- Trial name
- NCT01011387
- Testing
- NPWT System
- Where
- 2 sites in United Kingdom
- Volunteers
- 16 people
- Sponsor
- Molnlycke Health Care AB
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
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