Clinical trials: Extremity Amputation
Amputation, Amputation, Traumatic
Effects of Myoelectric Channel Count and Targeting for Upper Limb Prosthetic Control
The goal of this clinical trial is to systematically evaluate whether or not two commonly held fundamental assumptions for pattern recognition control translates to functional performance when tested on individuals aged 18 years…
- Conditions
- Amputation, Amputation, Traumatic, Amputation, Congenital, Prosthesis User
- Trial name
- NCT07011420
- Testing
- Experimental socket with 4 untargeted channels active, Experimental socket with 8 untargeted channels active, Experimental socket with up to 16 untargeted channels active
- Where
- 2 sites in United States
- Volunteers
- 32 people
- Sponsor
- Liberating Technologies, Inc.
Fall Prevention, Balance, Falls
Evaluating Methods to Replicate Stumbles and Slips During Walking
This protocol outlines a study designed to investigate three different methodologies for inducing gait perturbations. Subjects will be divided into two groups: prosthetic users and able-bodied individuals.
- Conditions
- Fall Prevention, Balance, Falls, Amputation of Lower Limb
- Trial name
- NCT07175714
- Testing
- Methodologies to induce gait perturbations
- Where
- 2 sites in Iceland
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- Össur Iceland ehf
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
Prosthesis User, Lower Limb Amputation Below Knee (Injury)
Caesar Foot Take-Home Validation Testing
The rationale for this study is to conduct a take-home clinical trial to evaluate the impact of the bimodal Caesar foot in a real-world environment.
- Trial name
- NCT07075198
- Testing
- Caesar Foot
- Where
- United States
- Volunteers
- 18 people
- Sponsor
- Liberating Technologies, Inc.
Peripheral Artery Disease, Critical Limb Ischemia
Temsirolimus Adventitial Delivery to Improve ANGioplasty and/or Atherectomy Revascularization Outcomes Below the Knee
A multicenter, randomized, double-blind, placebo-controlled trial to evaluate the effect of Temsirolimus Perivascular Injection 0.1 mg/mL on the incidence of ischemia-driven major amputation, clinically driven target lesion…
- Trial name
- TANGO-3 (NCT04433572)
- Testing
- Temsirolimus
- Where
- 2 sites in United States
- Volunteers
- 250 people
- Sponsor
- Mercator MedSystems, Inc.
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
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.
Ischemia, Peripheral Arterial Disease
Cook Micronized Small Intestinal Submucosa (SIS) for Critical Limb Ischemia
This study is intended to collect safety and effectiveness data on the Cook Micronized Small Intestinal Submucosa (SIS)
- Conditions
- Ischemia, Peripheral Arterial Disease, Peripheral Vascular Diseases
- Trial name
- NCT02044666
- Testing
- Micronized Small Intestinal Submucosa (SIS)
- Where
- Canada
- Volunteers
- 10 people
- Sponsor
- Cook Group Incorporated
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
Amputation Stumps, Amputees
Moisture Management Liner Effectiveness Study
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 non-breathable and non- thermally conductive materials that can create a warm…
- Conditions
- Amputation Stumps, Amputees, Amputation, Lower Limb Deformities, Congenital
- Trial name
- NCT04427007
- Testing
- Moisture Management Liner, Control Liner
- Where
- United States
- Volunteers
- 2 people, healthy volunteers welcome
- Sponsor
- Liberating Technologies, Inc.
Amputation Stumps, Pain
2PX (Topical Strontium Chloride Hexahydrate) in Patients With Post-Amputation Stump Pain.
The objective of this study is to investigate the analgesic effect of topical strontium chloride in stump pain, and to prospectively determine other efficacy and safety measures of topical strontium chloride in stump pain.
- Trial name
- NCT00592098
- Testing
- Strontium chloride hexahydrate
- Where
- Norway
- Volunteers
- 22 people
- Sponsor
- SantoSolve AS
Critical Limb Ischemia
Validation of OxyVu for Assessing Level of Amputation With Comparison to Other Modalities
Correlation of(OxyVu) values to to ABI, TBP, and TCOM in patients scheduled for foot level amputation because of critical limb ischemia, infection, or tissue necrosis.
- Trial name
- LOA (NCT00767923)
- Where
- United States
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- HyperMed
Amputation, Prosthesis User
Effects of Microprocessor-controlled Prosthetic Knees on Fall-related Health Outcomes in Limited Community Ambulators
The goal of this study is to find out if using microprocessor-controlled prosthetic knees (MPKs), prosthetic knees with a built-in computer, improves health outcomes related to falls in adults who use above-knee prostheses.
- Conditions
- Amputation, Prosthesis User, Amputation; Traumatic, Leg: Thigh, Between Hip and Knee, Limb; Absence, Congenital, Lower
- Trial name
- NCT06937242
- Testing
- Ottobock C-Leg 4 Microprocessor Knee, Ottobock Kenevo
- Where
- United States
- Volunteers
- 100 people
- Sponsor
- Hanger Institute for Clinical Research and Education, LLC
Upper Limb Amputation, Transradial Amputation
Cross-Over Study Evaluating the TASKA GEN2 Myoelectric Hand Prosthesis
This prospective multicentre randomized cross-over post-market clinical follow-up study compares the TASKA GEN2 multi-grip myoelectric hand prosthesis with marketed comparator prostheses in adults with upper-limb amputation.
- Conditions
- Upper Limb Amputation, Transradial Amputation, Transhumeral Amputation
- Trial name
- NCT07876115
- Testing
- TASKA GEN2 Multi-Grip Myoelectric Hand Prosthesis, Michelangelo or I-Limb Ultra multi-grip myoelectric prosthesis
- Where
- France
- Volunteers
- 20 people
- Sponsor
- TASKA Prosthetics
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
Transtibial Amputation, Artificial Limbs
Energy-Harvesting Mesofluidic Impulse Prosthesis: e-MIP
The purpose of this research is to validate the e-MIP design and function by testing the ability of e-MIP to harvest energy and return a sufficient amount of energy to assist the user during gait.
- Trial name
- NCT04157608
- Testing
- Habitual Prosthesis, Energy-Harvesting Mesofluidic Impulse Prosthesis
- Where
- United States
- Sponsor
- Orthocare Innovations, LLC
Prosthesis User, Congenital Amputation of Upper Limb
Pattern Recognition Prosthetic Control
Many different factors can degrade the performance of an upper limb prosthesis users control with electromyographic (EMG)-based pattern recognition control.
- Conditions
- Prosthesis User, Congenital Amputation of Upper Limb, Amputation; Traumatic, Limb
- Trial name
- Adaptation (NCT04272489)
- Testing
- EMG-Pattern Recognition Controller
- Where
- United States
- Volunteers
- 9 people
- Sponsor
- Coapt, LLC
Lower Limb Amputation
Evaluation of Limb Health Associated With a Prosthetic Vacuum Socket System
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
- NCT01839123
- Testing
- Prosthetic Suction or Pin Socket, Prosthetic LimbLogic Vacuum Socket
- Where
- 2 sites in United States
- Volunteers
- 10 people, healthy volunteers welcome
- Sponsor
- Ohio Willow Wood
Upper Limb Amputation Below Elbow (Injury)
Assessment of Gesture Accuracy of a Prosthesis Control System
The study is evaluating the performance of prosthesis control system, referred to as Phantom X, in able bodied individuals and individuals with upper limb amputation at the forearm level.
- Trial name
- ASCENT (NCT06446037)
- Testing
- Non-invasive EMG band instrumentation
- Where
- United States
- Volunteers
- 11 people, healthy volunteers welcome
- Sponsor
- Phantom Neuro Inc.
Amputation
EmPOWERing Active Seniors With Energy
A pilot study comparing the emPOWER Ankle System to standard carbon fiber prosthetic feet, in active seniors.
- Trial name
- EASE (NCT02958553)
- Testing
- emPOWER Ankle, Subject's own passive prosthesis
- Where
- United States
- Volunteers
- 8 people
- Sponsor
- Otto Bock Healthcare Products GmbH