Clinical trials: Amputations
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
Upper Limb Amputation
Functional Performance of Voluntary Opening and Closing Body Powered Prostheses
This study will compare the functional performance of voluntary opening (VO) and voluntary closing (VC) body powered prostheses.
- Trial name
- NCT02136238
- Testing
- Hosmer 5XA voluntary opening hook, TRS Grip 3 voluntary closing hook
- Where
- United States
- Volunteers
- 18 people, healthy volunteers welcome
- Sponsor
- University of South Florida
Amputation; Traumatic, Hand
To Assess the Utility of the Point Partial in a Clinical Take-home Study of Partial Hand Amputees
This study will allow us to assess whether the Point Partial confers functional and psychological benefit to persons with partial finger amputations in an unconstrained environment.
- Trial name
- NCT05012683
- Testing
- Point Partial
- Where
- 7 sites in United States
- Volunteers
- 11 people
- Sponsor
- Point Designs
Phantom Limb Pain
Treating Phantom Limb Pain Using Continuous Peripheral Nerve Blocks: A Department of Defense Funded Multicenter Study
When a limb is traumatically severed, pain perceived in the part of the body that no longer exists often develops. This is called "phantom limb" pain, and is different from "stump" pain, which is pain within the part of the limb…
- Trial name
- DoD-PLP-Tx (NCT01824082)
- Testing
- Perineural infusion [continuous peripheral nerve block(s)]
- Where
- 4 sites in United States
- Volunteers
- 144 people
- Sponsor
- University of California, San Diego
Amputation Stumps, Diabetes Mellitus
Evidence Based Amputee Rehabilitation (EBAR) Program
The purpose of this study is to determine if an evidence based exercise intervention improves the functional mobility of diabetic amputees (single lower leg amputation) who have already completed standard rehabilitation and…
- Trial name
- EBAR (NCT00126126)
- Testing
- EBAR Program
- Where
- United States
- Volunteers
- 20 people
- Sponsor
- US Department of Veterans Affairs
Lower Limb Amputation Above Knee (Injury)
C-Leg 3 and C-Leg 4 Study in Transfemoral Amputees
The aim of this post-market study is to confirm that the microprocessor controlled prosthetic knee components (C-Leg 3 and C-Leg 4) in comparison to mechanical knee joints can bring additional benefit to the users primarily on…
- Trial name
- NCT02765035
- Testing
- C-Leg 4, C-Leg 3
- Where
- 2 sites in Austria, Belgium
- Volunteers
- 18 people
- Sponsor
- Otto Bock Healthcare Products GmbH
Upper Limb Amputation
Brasthesis Prosthetic Harness for Women Veterans With Upper Limb Amputations
This project tests Brasthesis, a new product for women Veterans with upper limb loss. Brasthesis incorporates the harnessing straps that hold the prosthesis to the body into a heavy-duty sports bra.
- Trial name
- Brasthesis (NCT05179395)
- Testing
- Brasthesis
- Where
- United States
- Volunteers
- 5 people
- Sponsor
- VA Office of Research and Development
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
Traumatic Amputation
Strength, Pain and Function in Operation Iraqi Freedom/Operation Enduring Freedom Amputees: A Nurse-Managed Program
The purpose of this randomized control study is to determine if administering neuromuscular electrical stimulation (NMES) to the thigh muscles of a below the knee amputee is more effective than the current standard of care in…
- Trial name
- NCT00942890
- Testing
- NMES (EMPI 300PV stimulator) plus standard of care, TMARP standard of care
- Where
- 3 sites in United States
- Volunteers
- 44 people
- Sponsor
- University of Tennessee
Phantom Limb Pain, Amputation, Traumatic
Optimizing Rehabilitation for Phantom Limb Pain Using Mirror Therapy and Transcranial Direct Current Stimulation (tDCS)
This is a two-site study that explores the effects of mirror therapy and transcranial Direct Current Stimulation (tDCS, Soterix ©) in a randomized factorial controlled trial in which patients will be assigned to one of four…
- Trial name
- NCT02487966
- Testing
- transcranial Direct Current Stimulation (tDCS): active (Soterix ©), Mirror Therapy: active
- Where
- 2 sites in United States, Brazil
- Volunteers
- 132 people
- Sponsor
- Spaulding Rehabilitation Hospital
Traumatic Amputation of Lower Extremity
Functional Electrical Stimulation Use in Trans-tibial Amputations
The purpose of this study is to demonstrate the efficacy of functional electrical stimulation (FES) for trans-tibial amputees. The investigators aim to demonstrate that providing three months of FES intervention will increase…
- Trial name
- NCT02931396
- Testing
- FES
- Where
- United States
- Volunteers
- 20 people
- Sponsor
- Alicia Koontz
Peripheral Artery Disease
Efficacy and Safety of Rivaroxaban in Reducing the Risk of Major Thrombotic Vascular Events in Subjects With Symptomatic Peripheral Artery Disease Undergoing Peripheral Revascularization Procedures of the Lower Extremities
The purpose of study was to test whether rivaroxaban added to standard of care treatment, when compared to placebo, had the potential to reduce the incidence of the clinical events related to the clots and complications of the…
- Trial name
- VOYAGER PAD (NCT02504216)
- Testing
- Rivaroxaban (Xarelto, BAY59-7939)
- Where
- 532 sites in United States, Argentina and 32 more
- Volunteers
- 6,564 people
- Sponsor
- Bayer
Amputation Stumps
A Comparative Analysis Between College Park Sidekick Feet and Conventional Stubby Prosthesis
The purpose of this study is to compare the College Park Sidekicks to conventional stubby prosthetics to investigate their effects on bilateral above-knee-amputee gait velocity, exertion, and balance.
- Trial name
- NCT02921295
- Testing
- Sidekick Stubbies
- Where
- United States
- Volunteers
- 1 people, healthy volunteers welcome
- Sponsor
- Angela DeCandia
Amputation
Biomechanical Evaluation of a Novel, Compliant Low Profile Prosthetic Foot
The investigators have developed a novel layered low-profile prosthetic foot that is able to provide enhanced compliance without sacrificing strength for individuals with transtibial amputation who have long residual limbs.
- Trial name
- NCT06468059
- Testing
- Layered Low Profile Foot, Prescribed Ankle
- Where
- United States
- Volunteers
- 6 people
- Sponsor
- Little Room Innovations, LLC
Lower Limb Amputation Below Knee (Injury)
Wear and Tear Evaluation of New Nike Sport Sole for Runnnig Prosthesis
Running Specific Feet are based on the original Flex-Foot design using the energy storage and release function as the main design feature. Running specific prosthetic feet are intended for running and jogging.
- Trial name
- NCT04787640
- Testing
- Nike Sport Sole
- Volunteers
- 3 people
- Sponsor
- Össur Iceland ehf
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
Hemorrhage, Vascular Injury
A Transparent Elasticized Adhesive Occlusive Compression Bandage for Use as an Arterial Tourniquet
This cross-over study of twenty five (anticipated) healthy human subjects will utilize two active control devices, and two different widths of the investigational device.
- Trial name
- NCT02592655
- Testing
- Pneumatic Tourniquet, One Windlass Tourniquet, Two Windlass Tourniquets
- Where
- United States
- Volunteers
- 19 people, healthy volunteers welcome
- Sponsor
- Marcus Migura
Traumatic Amputation of Lower Extremity, Phantom Limb Pain
Spinal Cord Stimulation for Restoration of Function in Lower-Limb Amputees, 90-Day
The goals of this study are to provide sensory information to amputees and reduce phantom limb pain via electrical stimulation of the lumbar spinal cord and spinal nerves.
- Trial name
- SCS-90 (NCT04547582)
- Testing
- Spinal cord stimulator
- Where
- United States
- Volunteers
- 4 people
- Sponsor
- Lee Fisher, PhD
Amputation, Transfemoral Amputation
Investigation on a New Power Knee Firmware Update on Gait and Daily Life Activities for Transfemoral Amputees
The goal of this interventional study is to investigate a new firmware in development for Power Knee on gait and daily life activities in unilateral transfemoral amputees.
- Trial name
- NCT06620861
- Testing
- Power Knee Firmware Update, Power Knee Current Marketed Firmware
- Where
- United States
- Volunteers
- 6 people
- Sponsor
- Össur Iceland ehf
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