Clinical trials: Limb Amputation
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
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
Amputation, Amputation of Lower Limb
Cryo NerVe Block Extremity AmputatioN RegIStry for Post Operative and pHantom Limb Pain
The goal of this Registry is to see how the device is used when freezing nerves during an amputation procedure.
- Conditions
- Amputation, Amputation of Lower Limb, Amputation of Upper Limb, Amputation, Limb Loss
- Trial name
- VANISH (NCT06908538)
- Testing
- cryoablation
- Where
- 6 sites in United States
- Volunteers
- 2,000 people
- Sponsor
- AtriCure, Inc.
Amputation of Lower Limb, Prosthesis
LIMBER UniLeg: Rapid, On-demand, and Scaled-up Manufacturing of Customized Transtibial Prosthetic Legs for Amputees
The LIMBER UniLeg, a 3D printed single-piece transtibial prosthetic limb, is sufficiently equivalent to traditional passive prosthetic limbs (no motors or sensors), while reducing the cost and time of manufacturing and enabling…
- Conditions
- Amputation of Lower Limb, Prosthesis, Non-inferiority Trial of Prothesis
- Trial name
- NCT06648798
- Testing
- Limber Limb
- Where
- 2 sites in United States
- Volunteers
- 30 people
- Sponsor
- LIMBER Prosthetics & Orthotics Inc
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.
Lower Limb Amputation Above Knee, Lower Limb Amputation Below Knee
Study on a Prosthetic Foot With Adjustable Heel Height
Most prosthetic feet have a fixed heel height, which requires users to always wear shoes with the same heel height. A fixed heel height is a significant constraint, whereas the ability to choose one's clothing freely is an…
- Trial name
- ADJUST (NCT07214493)
- Testing
- Taleo Adjust, The usual participant's foot
- Where
- 5 sites in France
- Volunteers
- 30 people
- Sponsor
- Otto Bock France SNC
Upper Limb Amputation Below Elbow (Injury), Wrist Disarticulation
Evaluation of the Phantom X Implantable EMG Sensor System for Myoelectric Prosthesis Control
The CYBORG Study is a first-in-human clinical investigation evaluating the safety and performance of the Phantom X System, an implantable electromyography (EMG) sensor array designed to provide control of upper-limb prostheses.
- Conditions
- Upper Limb Amputation Below Elbow (Injury), Wrist Disarticulation, Transradial Amputation
- Trial name
- CYBORG (NCT07325708)
- Testing
- Phantom X multielectrode EMG sensor array implant for upper limb prosthesis control
- Where
- 2 sites in Australia
- Volunteers
- 10 people
- Sponsor
- Phantom Neuro Inc.
Lower Limb Amputation Above Knee (Injury)
New Microprocessor-Controlled Prosthetic Knee Evaluation
The target of this clinical investigation is to compare the achievement of personal functional goals using a new MPK and current MPK.
- Trial name
- NCT06017024
- Testing
- microprocessor-controlled knee (MPK) assessment
- Where
- 5 sites in France
- Volunteers
- 18 people
- Sponsor
- Proteor Group
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.
Amputation of Upper Limb
A Multicenter, Multinational, Cohort Long-term Post-market Clinical Follow-up (PMCF) of the Safety and Efficacy of the Osseoanchored Prostheses for the Rehabilitation of Amputees (OPRA) Implant System When Used for Transhumeral Implantation in Amputee Patients
This non-interventional clinical investigation is initiated for the purpose of long-term Post-Market Clinical Follow-up (PMCF) and the follow-up time of patients is expected to span from 6 months to >20 years in function.
- Trial name
- ReTHro (NCT06753110)
- Testing
- OPRA transhumeral
- Where
- 6 sites in Australia, Austria and 3 more
- Volunteers
- 70 people
- Sponsor
- Integrum
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
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
Amputation, Amputation; Traumatic, Leg, Lower
Clinical Outcomes With Non-Powered vs. Powered Prosthetic Knees by K2-level Amputees
The goal of this proposed project is to gather community-based data from the K2-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
- NCT06194838
- Testing
- Ossur Power Knee, Reboocon Intuy Knee
- Where
- United States
- Volunteers
- 26 people
- Sponsor
- Liberating Technologies, Inc.
Amputation
Detecting Change in Muscle Parameters, Pain, and Function With NMES for TTA
The proposal aims to investigate a non-invasive, cost-effective method for rebuilding muscle mass in individuals with transtibial limb loss.
- Trial name
- NCT06830876
- Testing
- Chattanooga Continuum Device
- Where
- United States
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- Sara Peterson-Snyder
Peripheral Arterial Disease, Peripheral Vascular Disease
Safety Study of MultiGeneAngio in Patients With Chronic Critical Limb Ischemia
The purpose of this study is to evaluate the safety and activity of two doses of MultiGeneAngio, a cell therapy product produced from the patient's own cells, as potential treatment for patients with chronic critical limb…
- Conditions
- Peripheral Arterial Disease, Peripheral Vascular Disease, Critical Limb Ischemia
- Trial name
- NCT00956332
- Testing
- MultiGeneAngio
- Where
- 7 sites in Israel
- Volunteers
- 28 people
- Sponsor
- MultiGene Vascular Systems Ltd.
Amputation; Traumatic, Arm, Upper, Amputation; Traumatic, Arm: Forearm
Study of the Social and Professional Reintegration Improvements Using a Set of Solutions for Upper Limb Amputation
ORTHOPUS develops assistive technologies to address the lack of availability of medical devices in low and middle income countries.
- Conditions
- Amputation; Traumatic, Arm, Upper, Amputation; Traumatic, Arm: Forearm, Amputation; Traumatic, Hand, at Wrist Level, Wounds and Injuries
- Trial name
- NCT04803253
- Testing
- ORTHOPUS prosthetic accessory: 0109 - Universal Wrist, ORTHOPUS prosthetic terminal device: 0112 - Hook, ORTHOPUS prosthetic terminal device: 0105 - Cosmetic Articulated Hand
- Where
- 3 sites in Nepal
- Volunteers
- 14 people
- Sponsor
- Orthopus
Amputation
Evaluation of a Pro-Active Dynamic Accommodating Socket
The primary objective of this study is to assess the effectiveness of the pro-active dynamic socket (PADS) on increasing socket comfort and fit for transfemoral and transtibial amputees during ambulation and rest, addressing…
- Trial name
- PADS (NCT01546311)
- Testing
- Pro Active Dynamic Accommodating Socket
- Where
- 2 sites in United States
- Volunteers
- 5 people
- Sponsor
- Infoscitex Corporation
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
Lower Limb Amputation Above Knee (Injury)
Assessment of the Prosthetic System Impact on Mental Workload in Above-knee Lower Limb Amputees.
New generation of lower limb prosthesis provide improved functionalities. They are usually studied in the scope of biomechanics, sometimes PROMs like quality of life.
- Trial name
- INCREMENT (NCT06635655)
- Where
- France
- Volunteers
- 9 people
- Sponsor
- Proteor Group
Lower Limb Amputation Above Knee (Injury)
Above-knee Socket Evaluation : Sub-ischial vs Ischial Containment
Socket is key to provide comfort and function to lower limb amputees. A new socket, the sub-ischial socket, will be compared to "traditional" ischial containment sockets, based on comfort self-evaluation, and locomotor capacities.
- Trial name
- P20-EMBSUBI (NCT04791163)
- Testing
- Socket evaluation
- Where
- 9 sites in France
- Volunteers
- 25 people
- Sponsor
- Proteor Group