Clinical trials: Limb Amputation
Post-Amputation Pain, Phantom Limb Pain
Electrical Nerve Block for Amputation Pain
The purpose of the clinical trial is to learn whether electrical nerve block via the Altius System is a safe and effective treatment for patients with post-amputation pain.
- Conditions
- Post-Amputation Pain, Phantom Limb Pain, Residual Limb Pain, Stump Pain
- Trial name
- NCT02221934
- Testing
- Altius
- Where
- 22 sites in United States
- Volunteers
- 607 people
- Sponsor
- Neuros Medical, Inc.
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
Transfemoral Amputation, Artificial Limbs
Assist-Knee: Energy-Harvesting Knee Prosthesis
The purpose of this research is to validate the Assist-Knee design and function by collecting pilot data during the stand-to-sit-to-stand transition in transfemoral prosthesis users when using the Assist-Knee to harvest energy…
- Trial name
- NCT04023045
- Testing
- Assist-Knee, Habitual Prosthesis
- Where
- United States
- Volunteers
- 3 people
- Sponsor
- Orthocare Innovations, LLC
Amputation
Pro APP Prosthetic Outcome Registry
A national, multi-center registry of patients using lower-limb prosthesis, their profiles and devices, and their long-term follow-up and clinical outcomes.
- Trial name
- NCT06210620
- Where
- United States
- Volunteers
- 2,000 people
- Sponsor
- Össur Iceland ehf
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
Amputation, Upper Limb
Study of Efficacy of the MyoTrain System in a Population of Individuals With Trans-radial Limb Loss
The investigators propose to evaluate the efficacy of MyoTrain in a prospective clinical study involving 16 individuals with trans-radial upper-limb loss over a period of 206 days.
- Trial name
- NCT05888428
- Testing
- MyoTrain, Motor Imagery
- Where
- United States
- Volunteers
- 16 people
- Sponsor
- Infinite Biomedical Technologies
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
Peripheral Vascular Disease
Efficacy/Safety of Ecraprost in Lipid Emulsion for Treatment of Critical Leg Ischemia Due to Peripheral Arterial Disease
Ecraprost in lipid emulsion is being developed for the treatment of Critical leg ischemia (CLI), which is the most severe form of peripheral arterial disease (PAD); This trial is designed to assess the efficacy and safety of the…
- Trial name
- NCT00059657
- Testing
- Ecraprost in lipid emulsion
- Where
- 22 sites in United States, United Kingdom
- Volunteers
- 280 people
- Sponsor
- Tanabe Pharma Corporation
Amputation, Upper Limb
Regulatory Clearance of the Glide Control Strategy for Upper Limb Prostheses
The investigators will test the following hypothesis: Use of Glide results in improved functional performance, satisfaction, and usage metrics as compared to use of a standard Direct Control (DC) prosthesis.
- Trial name
- NCT06539936
- Testing
- Glide, Direct Control
- Where
- United States
- Volunteers
- 7 people
- Sponsor
- Infinite Biomedical Technologies
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.
Critical Limb Ischemia, Peripheral Arterial Disease
Pilot Safety Study of Injectable SIS for Critical Limb Ischemia
This study is intended to collect safety and effectiveness data on the Cook Injectable Small Intestinal Submucosa (SIS)
- Conditions
- Critical Limb Ischemia, Peripheral Arterial Disease, Peripheral Vascular Disease
- Trial name
- CLIC (NCT02145845)
- Testing
- Injectable SIS
- Where
- Czechia
- Volunteers
- 13 people
- Sponsor
- Cook Group Incorporated
Diabetes Mellitus, Type 2
Sodium-glucose Co-transporter 2 (SGLT2) Inhibitor Risk of Below-Knee Lower Extremity Amputation: A Retrospective Cohort Study Using a Large Claims Database in the United States
The purpose of the study is to estimate the incidence of below-knee lower extremity amputation in type 2 diabetes mellitus (T2DM) participants newly exposed to sodium-glucose co-transporter 2 inhibitors (SGLT2i)/ non-SGLT2i…
- Trial name
- NCT02857764
- Volunteers
- 127,690 people
- Sponsor
- Janssen Research & Development, LLC
Peripheral Vascular Disease
Safety/Feasibility Study of HBOC-201 in Amputation at/Below Knee From Critical Lower Limb Ischemia
The purpose of this study is to assess the safety and feasibility of HBOC-201 in increasing adequate wound healing in patients with severe peripheral vascular disease who are undergoing lower limb amputation.
- Trial name
- NCT00300040
- Testing
- Hemoglobin glutamer 250 - bovine, 6% Hydroxyethylstarch
- Where
- 5 sites in South Africa, United Kingdom
- Volunteers
- 16 people
- Sponsor
- Biopure Corporation
Peripheral Arterial Disease Below the Knee, Peripheral Arterial Disease, Rutherford 4 and 5 with Possibility to Improve Vascularization
Below-the-Knee Interventions for Limb Salvage: Use of Multifunctional Angioplasty Balloon Catheters
Below-the-Knee Interventions for Limb Salvage: Use of Multifunctional Angioplasty Balloon Catheters ("BTK Multicath Registry") A non-randomized clinical registry This study is designed to obtain preliminary data on clinically…
- Trial name
- NCT06906055
- Testing
- Multicath, Standard of Care (SOC)
- Where
- 2 sites in United States
- Volunteers
- 24 people
- Sponsor
- Summa Therapeutics, LLC
Amputation
e-OPRA Implant System for Lower Limb Amputees
The e-OPRA Implant System, is a further development of the OPRA (Osseointegrated Prostheses for the Rehabilitation of Amputees) Implant System, approved under HDE (Humanitarian Device Exemption) H080004.
- Trial name
- NCT03720171
- Testing
- e-OPRA Implant System
- Where
- United States
- Volunteers
- 2 people
- Sponsor
- Integrum
Lower Limb Amputation
Evaluation of a Novel Transfemoral Prosthetic Socket System
The purpose of the study is to evaluate residual limb circulation and skin health associated with the use of a novel prosthetic transfemoral socket system.
- Trial name
- NCT01846845
- Testing
- Conventional Prosthetic Transfemoral Socket System, Novel Prosthetic transfemoral socket system
- Where
- 2 sites in United States
- Volunteers
- 8 people, healthy volunteers welcome
- Sponsor
- Ohio Willow Wood
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, Amputation, Traumatic
Evaluation of Dexterous Terminal Device
Liberating Technologies, Inc. (LTI) has developed Pointdexter, a dexterous prosthetic fingertip that is integrated into a commercial prosthetic hand and allows for an additional fine grasp.
- Conditions
- Amputation, Amputation, Traumatic, Amputation; Traumatic, Hand, Limb; Absence, Congenital, Upper
- Trial name
- NCT05840601
- Testing
- Pointdexter, Comparator
- Sponsor
- Liberating Technologies, Inc.
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.
Amputation
Comparative Study Evaluating the Mobility of Transtibial Amputee Patients Using the PRO-FLEX PIVOT® Foot Versus a Class III Energy Storing and Returning (ESAR) Prosthetic Foot.
The PRO-FLEX PIVOT® is ESAR prosthetic foot with an innovative technology built around three pillars: 1. The PIVOT technology: three axes of rotation (upper support, main pivot and lower support) at the ankle, which allow both a…
- Trial name
- DEFI (NCT06627361)
- Testing
- PRO-FLEX PIVOT Foot evaluation, Class III ESAR Foot evaluation
- Where
- France
- Volunteers
- 30 people
- Sponsor
- Össur Iceland ehf