Clinical trials: Amputation
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
Amputation Stumps
Investigation Into the Functional Performance of a New Thermoplastic Elastomer (TPE) Transtibial Liner
The clinical investigation is designed as an uncontrolled open prospective, multicenter, 2 group, pre-test post-test study. Testing will be conducted in the USA and Canada at 3-6 clinics, depending on enrolment requirements.
- Trial name
- NCT02622919
- Testing
- TPE Liner
- Where
- United States
- Volunteers
- 14 people
- Sponsor
- Össur Iceland ehf
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, 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
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
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
Upper Limb Amputation
Osseointegrated Human-Machine Gateway
Advanced prosthetic devices are currently controlled by electromyography (EMG) signals generated by patient's stump muscles and recorded by surface electrodes attached on the skin.
- Trial name
- OHMG (NCT03178890)
- Testing
- OHMG
- Where
- Sweden
- Volunteers
- 18 people
- Sponsor
- Integrum
Peripheral Arterial Occlusive Disease
Gene Expression and Tolerability Study of NV1FGF in Patients With Peripheral Artery Occlusive Disease Planned to Undergo Major Amputation
The primary objective is to evaluate the transgene expression (synthesis of FGF-1 mRNA) in injected tissue, at injection site, after Intra Muscular (IM) administration of increasing single doses of NV1FGF.
- Trial name
- NCT01157143
- Testing
- XRP0038 (NV1FGF)
- Where
- 2 sites in United States, Switzerland
- Volunteers
- 6 people
- Sponsor
- Sanofi
Amputation of Upper Limb
Observational Study of People with Complete Hand Amputation Using a Multi-grip Myoelectric Prosthesis a Following Using a Standard Myoelectric Prosthesis
Cases of unilateral or bilateral upper limb amputation result in functional and aesthetic disability and a marked deterioration in quality of life.
- Trial name
- PROMISE (NCT06452472)
- Testing
- I-LIMB
- Where
- France
- Volunteers
- 25 people
- Sponsor
- Össur Iceland ehf
Prosthesis User, Amputation
Biomechanical Assessment of Load Applied on Residuum of Individuals With Limb Loss Fitted With a Prosthetic Limb
This study will aim at performing biomechanical analyses of the actual load applied on the end of the stump (residuum) of individuals with transfemoral limb loss fitted with bionics bone-anchored prostheses during activities of…
- Trial name
- NCT05870267
- Testing
- Power Knee with bone anchored suspension, C-Leg, Rheo Knee XC
- Where
- Australia
- Volunteers
- 20 people
- Sponsor
- YourResearchProject Pty Ltd
Fall Prevention, Balance, Falls
Evaluating Stumble Recovery Functions of Prosthetic Knees
The study aims to conduct a formative evaluation, along with verification, validation, and comparative analysis of the stumble recovery function in prosthetic devices by collecting relevant clinical data.
- Conditions
- Fall Prevention, Balance, Falls, Amputation of Lower Limb
- Trial name
- NCT07266454
- Testing
- Prosthetic Knee (e.g Power Knee, Navii, Rheo Knee, ...)
- Where
- 2 sites in Iceland
- Volunteers
- 50 people
- Sponsor
- Össur Iceland ehf
Peripheral Vascular Diseases
Efficacy and Safety of XRP0038/NV1FGF in Critical Limb Ischemia Patients With Skin Lesions
Primary objective is to demonstrate the superiority of riferminogene pecaplasmid (XRP0038/NV1FGF) over placebo in the prevention of major amputation above the ankle of the treated leg or of death from any cause, whichever comes…
- Trial name
- TAMARIS (NCT00566657)
- Testing
- riferminogene pecaplasmid
- Where
- 32 sites in United States, Argentina and 30 more
- Volunteers
- 525 people
- Sponsor
- Sanofi
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
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.
Post-Amputation Pain, Phantom Limb Pain
Electrical Stimulation for the Treatment of Post-Amputation Pain Using the SPRINT System
The purpose of this study is to determine if electrical stimulation (small levels of electricity) can safely and effectively reduce post-amputation pain. This study involves a device called the SPRINT System.
- Conditions
- Post-Amputation Pain, Phantom Limb Pain, Residual Limb Pain
- Trial name
- NCT01996254
- Testing
- SPRINT Peripheral Nerve Stimulation (PNS) System
- Where
- 10 sites in United States
- Volunteers
- 28 people
- Sponsor
- SPR Therapeutics, 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
Amputation
Clinical Investigation (Beta) of a New Developed Prosthetic Knee
The aim of this investigation is to evaluate the efficacy of the investigational device regarding performance improvements and satisfaction in descending activities for moderate to high active prosthesis users within the intended…
- Trial name
- NCT06748729
- Testing
- Navii Knee
- Where
- United States
- Volunteers
- 11 people
- Sponsor
- Össur Iceland ehf
Amputation, Amputation; Traumatic, Leg, Lower
Socket Cooling Effectiveness Take Home 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, Amputation; Traumatic, Leg, Lower, Amputation Stump, Limb; Absence, Congenital, Lower
- Trial name
- NCT04484805
- Testing
- ICE Condition
- Where
- 2 sites in United States
- Volunteers
- 12 people, healthy volunteers welcome
- Sponsor
- Liberating Technologies, Inc.
Prosthesis User
Efficacy of a Vented Liner and Socket System for Individuals With Trans-femoral Amputation
The objective of the investigation is to measure the humidity within a transfemoral amputee's prosthesis during physical activity in a pre-heated room, using both the vented AeroFit system and a non-vented comparator.
- Trial name
- NCT05279885
- Testing
- Vented suspension system, Non-vented suspension system
- Where
- United States
- Volunteers
- 13 people
- Sponsor
- Jóna Valgerður Kristjánsdóttir