Clinical trials: Limb Amputation
Phantom Limb Pain, Postoperative Pain
Postoperative Peripheral Nerve Stimulation for Management of Post-amputation Pain
Limb loss is frequently associated with postamputation pain that can be challenging to treat and often involves opioids. Advances in the field of neuromodulation has led to development of an intentionally reversible percutaneous…
- Conditions
- Phantom Limb Pain, Postoperative Pain, Neuroma, Acute Pain
- Trial name
- NCT03484429
- Testing
- Peripheral nerve stimulation, Standard Medical Therapy
- Where
- United States
- Volunteers
- 16 people
- Sponsor
- Hunter Holmes Mcguire Veteran Affairs Medical Center
Traumatic Amputation of Lower Extremity, Phantom Limb Pain
Spinal Cord Stimulation for Restoration of Function in Lower-Limb Amputees, 90-Day
The goals of this study are to provide sensory information to amputees and reduce phantom limb pain via electrical stimulation of the lumbar spinal cord and spinal nerves.
- Trial name
- SCS-90 (NCT04547582)
- Testing
- Spinal cord stimulator
- Where
- United States
- Volunteers
- 4 people
- Sponsor
- Lee Fisher, PhD
Lower Extremity Amputation
Pivot-Flex Foot: Optimal Coupling Ratio Between Transverse and Sagittal-plane Motions Using a Torsionally Adaptive Prosthesis for Individuals With Lower Limb Amputation
When prescribing a prosthetic foot, clinicians face a dizzying array of choices as more than 200 different prosthetic feet are available.
- Trial name
- NCT03532100
- Testing
- Torsionally adaptive prosthesis with 0:1 coupling ratio, Torsionally adaptive prosthesis with 1:6 coupling ratio, Torsionally adaptive prosthesis with 1:4 coupling ratio
- Where
- United States
- Volunteers
- 14 people
- Sponsor
- VA Office of Research and Development
Pain Management
A Non-invasive Intervention (BreEStim) for Management of Phantom Limb Pain (PLP) After Limb Amputation (Experiment 2)
The purpose of this study is to compare the effectiveness of innovative intervention of breathing controlled electrical stimulation (BreEStim) and conventional electrical stimulation (EStim) in management of neuropathic phantom…
- Trial name
- NCT04750538
- Testing
- BreEStim 120, BreEStim 240
- Where
- United States
- Volunteers
- 17 people
- Sponsor
- The University of Texas Health Science Center, Houston
Amputation, Surgical, Amputation, Traumatic
Cryoanalgesia to Treat Phantom Limb Pain Following Above-Knee Amputation
When a limb is severed, pain perceived in the part of the body that no longer exists often develops and is called "phantom limb" pain.
- Conditions
- Amputation, Surgical, Amputation, Traumatic, Phantom Limb Pain, Phantom Pain Following Amputation of Lower Limb
- Trial name
- NCT06071715
- Testing
- ACTIVE cryoneurolysis
- Where
- United States
- Volunteers
- 12 people
- Sponsor
- University of California, San Diego
Lower Extremity Amputation
Adherence and Perspiration While Wearing Lower Limb Prostheses
Individuals with lower limb amputation often complain about uncomfortable residual limb skin temperatures and the accumulation of sweat inside their prostheses.
- Trial name
- NCT03900845
- Testing
- Dynamic Air Exchange - Rising Edge Design (DAE-RED), Perforated elastomeric liner, As-prescribed prosthesis
- Where
- United States
- Volunteers
- 20 people
- Sponsor
- Seattle Institute for Biomedical and Clinical Research
Transtibial Amputation
Evaluation of a Modified Running-specific Prosthetic Foot
The goal of this study is to evaluate endurance, walking performance, mobility, and perceived exertion of transtibial prosthesis users (i.e., study participants) walking with a conventional energy storing prosthetic foot (ESF)…
- Trial name
- NCT02440711
- Testing
- Energy storing foot (ESF), Modified running specific foot (mRSF)
- Where
- United States
- Volunteers
- 36 people
- Sponsor
- University of Washington
Diabetes Mellitus, Leg Injuries
Prosthetic Components and Stability in Amputee Gait
The biomechanics of changing direction while walking has been largely neglected despite its relevancy to functional mobility. In addition, an increased risk of injury can be associated with turning due to a decrease in stability.
- Conditions
- Diabetes Mellitus, Leg Injuries, Traumatic Amputation
- Trial name
- NCT00167778
- Testing
- Transverse plane rotation adaptor pylon, Rigid pylon
- Where
- United States
- Volunteers
- 12 people, healthy volunteers welcome
- Sponsor
- US Department of Veterans Affairs
Amputation, Amputation; Postoperative, Sequelae
Evaluation of Closed Incision Negative Pressure Dressing (PREVENA) to Prevent Lower Extremity Amputation Wound Complications
This study is a prospective, multi-center, two-arm, unblinded, and randomized controlled trial with a goal of evaluating the impact of a closed incision negative pressure dressing (PREVENA) on incidence of post-operative wound…
- Conditions
- Amputation, Amputation; Postoperative, Sequelae, Wound Dehiscence, Seroma
- Trial name
- PREVENA-AMP (NCT03773575)
- Testing
- PREVENA™ PEEL & PLACE™ Dressing Kit
- Where
- 3 sites in United States, Italy
- Volunteers
- 272 people
- Sponsor
- Thomas Jefferson University
Pain Management
A Non-invasive Intervention (BreEStim) for Management of Phantom Limb Pain (PLP) After Limb Amputation (Experiment 3)
The purpose of this study is to compare the effectiveness of innovative intervention of breathing controlled electrical stimulation (BreEStim) and conventional electrical stimulation (EStim) in management of neuropathic phantom…
- Trial name
- NCT04751526
- Testing
- BreEStim 240, EStim 240
- Where
- United States
- Volunteers
- 18 people
- Sponsor
- The University of Texas Health Science Center, Houston
Amputation of Lower Limb
Assessment of Safety and Performances of a 3D Printed Prosthetic Foot: A Pilot Study
A dynamic energy storage and return foot prosthesis is a type of prosthesis designed to mimic and restore the functionality and natural movement of the limb that has been amputated.
- Trial name
- NCT06938087
- Testing
- 3D printed prosthesis foot, Current prosthesis foot
- Where
- Italy
- Volunteers
- 3 people
- Sponsor
- Istituto Nazionale Assicurazione contro gli Infortuni sul Lavoro
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
Development of Adaptive Vacuum Suspension to Improve Prosthetic Fit and Residual Limb Health
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
- DoD (NCT03927404)
- Testing
- Active vacuum test prosthesis
- Where
- United States
- Volunteers
- 60 people
- Sponsor
- Indiana University
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.
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.
Peripheral Artery Disease, Vascular Disease
Use of Autologous Concentrated Bone Marrow Aspirate in Preventing Wound Complications in Below Knee Amputation (BKA)
Patients scheduled for major extremity lower amputation to receive bone marrow cells (cBMA) injected IM in the leg proximal to the amputation in the index limb to prevent ischemic wound complications after surgery.
- Conditions
- Peripheral Artery Disease, Vascular Disease, Critical Limb Ischemia
- Trial name
- MarrowCHAMP (NCT02863926)
- Testing
- Injection of cBMA aspirate into the index leg
- Where
- United States
- Volunteers
- 6 people
- Sponsor
- Michael Murphy
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.
Traumatic Amputation of Lower Extremity
Functional Electrical Stimulation Use in Trans-tibial Amputations
The purpose of this study is to demonstrate the efficacy of functional electrical stimulation (FES) for trans-tibial amputees. The investigators aim to demonstrate that providing three months of FES intervention will increase…
- Trial name
- NCT02931396
- Testing
- FES
- Where
- United States
- Volunteers
- 20 people
- Sponsor
- Alicia Koontz
Upper Limb Amputation
Functional Performance of Voluntary Opening and Closing Body Powered Prostheses
This study will compare the functional performance of voluntary opening (VO) and voluntary closing (VC) body powered prostheses.
- Trial name
- NCT02136238
- Testing
- Hosmer 5XA voluntary opening hook, TRS Grip 3 voluntary closing hook
- Where
- United States
- Volunteers
- 18 people, healthy volunteers welcome
- Sponsor
- University of South Florida
Pain Management
A Non-invasive Intervention (BreEStim) for Management of Phantom Limb Pain (PLP) After Limb Amputation (Experiment 1)
The purpose of this study is to compare the effectiveness of innovative intervention of breathing controlled electrical stimulation (BreEStim) and conventional electrical stimulation (EStim) in management of neuropathic phantom…
- Trial name
- NCT04750525
- Testing
- BreEStim, EStim
- Where
- United States
- Volunteers
- 15 people
- Sponsor
- The University of Texas Health Science Center, Houston