Clinical trials: Extremity Amputation
Foot Ulcer, Diabetic
NEOX® CORD 1K vs Standard of Care in Non-healing Diabetic Foot Ulcers
In this randomized, multi-center, cross-over study, the efficacy and safety of NEOX® CORD 1K will be evaluated in patients suffering from non-healing diabetic foot ulcers.
- Trial name
- CONDUCT I (NCT02166294)
- Testing
- NEOX® CORD 1K, Standard of Care (Pressure Bandage)
- Where
- 3 sites in United States
- Volunteers
- 18 people
- Sponsor
- Amniox Medical, 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
Lower Limb Amputation Below Knee (Injury), Lower Limb Amputation Above Knee (Injury)
Feasibility Study to Evaluate a New Energy Storage and Return Prosthetic Foot
A prospective, interventional, multicenter pilot study to characterize differences in performance and patient reported outcomes between the Taleo, Proflex XC, and the new Revo prosthetic foot.
- Conditions
- Lower Limb Amputation Below Knee (Injury), Lower Limb Amputation Above Knee (Injury), Lower Limb Amputation Knee
- Trial name
- NCT04239222
- Testing
- Revo-M, Taleo, Proflex XC
- Where
- 4 sites in United States
- Volunteers
- 27 people
- Sponsor
- Otto Bock Healthcare Products GmbH
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
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.
Amputation
Clinical Evaluation of Direct Manufactured Prosthetic Sockets
The purpose of this study is to evaluate a new prosthetic socket construction technique in order to improve the quality of care to lower extremity amputees.
- Trial name
- NCT01155024
- Testing
- Traditional fabricated prosthetic socket, Direct manufactured (DM) prosthetic socket
- Where
- United States
- Volunteers
- 10 people
- Sponsor
- Ohio Willow Wood
Diabetic Foot, Arterial Occlusive Disease
Urokinase Therapy in Patients With Diabetic Foot Syndrome
The purpose of this study is to determine whether the additional therapy with low dose urokinase is more effective than only a conventional standard therapy concerning ulcer-healing, rate of major amputation and survival.
- Conditions
- Diabetic Foot, Arterial Occlusive Disease, Ischemia
- Trial name
- NCT00823225
- Testing
- standard therapy, Urokinase
- Where
- 6 sites in Germany
- Volunteers
- 5 people
- Sponsor
- medac GmbH
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
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
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 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
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
Diabetes Mellitus, Type 2
This Study Combines Data From 3 Other Studies Testing Empagliflozin in Patients With Diabetes or With Chronic Heart Failure. The Study Looks at the Numbers of Patients Who Had Lower Limb Amputations
The primary objective of this exploratory meta-analysis is to evaluate the frequencies, incidence rates, and hazard ratios of lower-limb amputation (LLA) events (primary outcome) and of adverse events related to amputation…
- Trial name
- NCT04937816
- Testing
- Empagliflozin
- Where
- Germany
- Volunteers
- 16,746 people
- Sponsor
- Boehringer Ingelheim
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.
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
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
Amputation
A Unique Body-Powered Terminal Device With Enhanced Grasping Capabilities for Individuals With Upper Limb Loss
We have developed a novel terminal device for a prosthetic arm that eliminates the functional tradeoffs seen in body-powered voluntary open devices.
- Trial name
- NCT07254247
- Testing
- Novel Prosthetic Hook, Control Hook (Light Spring), Control Hook (Heavy Spring)
- Where
- United States
- Volunteers
- 8 people, healthy volunteers welcome
- Sponsor
- Little Room Innovations, LLC
Amputation, Limb Deficiencies
Assessing the DSR Ankle
This research is being done to conduct a preliminary investigation into a new prosthetic microprocessor controlled (MPC) ankle, called the Damping, Stiffness, and Repositioning (DSR) ankle.
- Trial name
- NCT05955378
- Testing
- DSR Ankle, Predicate Ankle
- Where
- United States
- Volunteers
- 5 people
- Sponsor
- Synchro Motion LLC
Complete or Incomplete Paraplegia/quadriplegia, Spinal Cord Injury
Research on Wireless Brain Implant System for General Control of External Devices
The clinical trial aims to evaluate the safety and efficacy of the minimally invasive, wireless brain-machine interface system (WRS) in enabling general brain control of external devices, such as a cursor and other assistive…
- Conditions
- Complete or Incomplete Paraplegia/quadriplegia, Spinal Cord Injury, Brainstem Stroke, Amyotrophic Lateral Sclerosis
- Trial name
- RISE (NCT06829212)
- Testing
- WRS
- Where
- China
- Volunteers
- 4 people
- Sponsor
- Shanghai StairMed Technology Co., Ltd.
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