Clinical trials: Lower Extremity Amputation
Lower Extremity Surgical Amputation, Post-amputation Phantom Limb Pain
Improving Postamputation Functioning by Decreasing Phantom Pain With Perioperative Continuous Peripheral Nerve Blocks: A Department of Defense Funded Multicenter Study
When a limb is amputated, pain perceived in the part of the body that no longer exists often develops, called "phantom limb" pain.
- Trial name
- NCT03461120
- Testing
- Experimental continuous peripheral nerve blocks, Control continuous peripheral nerve blocks
- Where
- 8 sites in United States
- Volunteers
- 208 people
- Sponsor
- University of California, San Diego
Amputation of Lower Extremity, All Causes
Gait and Energy Expenditure in Children With Lower Limb Amputation (MAPEDE)
In lower limb amputation, prosthetic gait has been shown to be particularly energy-intensive. While energy expenditure has been the focus of many studies in adult amputees, this area of research is less developed for paediatric…
- Trial name
- MAPEDE (NCT07076602)
- Testing
- Gait and energy expenditure
- Where
- 8 sites in France
- Volunteers
- 48 people
- Sponsor
- Rennes University Hospital
Infections, Infected Wound
PO vs IV Antibiotics for the Treatment of Infected Nonunion of Fractures After Fixation
This is a Phase III clinical randomized control trial to investigate differences between patient with an infected nonunion treated by PO vs. IV antibiotics.
- Conditions
- Infections, Infected Wound, Nonunion of Fracture, Injury Leg
- Trial name
- POvIV2 (NCT05699174)
- Testing
- Standard of Care PO (oral) antibiotics, Standard of Care Intravenous (IV) antibiotics
- Where
- 13 sites in United States
- Volunteers
- 250 people
- Sponsor
- Major Extremity Trauma Research Consortium
Lower Extremity Amputation
Improving Prosthetic Provision in Rural Communities: Limb Scanning With Caregiver Assistance
When the prosthetic socket of a Veteran with a lower limb amputation no longer fits or is damaged beyond repair, a new prosthetic socket is warranted.
- Trial name
- NCT05884203
- Testing
- Caregiver socket, Prosthetist socket
- Where
- United States
- Volunteers
- 17 people
- Sponsor
- VA Office of Research and Development
Lower Extremity Amputation
Adjustable Prosthetic Sockets for Individuals With Lower Limb Amputation
Each year, around 1500 Veterans join the 623,000 Americans who live with a lower limb amputation. Many of these Veterans choose the arduous path of rehabilitation to remain ambulatory, a process that includes the prescription of…
- Trial name
- NCT07397169
- Testing
- Adjustable prosthetic socket
- Where
- United States
- Volunteers
- 25 people
- Sponsor
- VA Office of Research and Development
Lower Extremity Amputation, Trans-Tibial Amputation
Kinematics of Ewing Amputees
The agonist-antagonist myoneural interface (AMI) construct, known as the Ewing amputation at the trans-tibial level, has been shown to create a bi-directional neural communication platform as a means of controlling and…
- Conditions
- Lower Extremity Amputation, Trans-Tibial Amputation, Traumatic Lower Extremity Amputation, Agonist-Antagonist Myoneural Interface
- Trial name
- NCT06371209
- Testing
- Modified Amputation, Standard Amputation
- Where
- United States
- Volunteers
- 32 people
- Sponsor
- Brigham and Women's Hospital
Amputation; Lower Extremity, Pain, Persistent Postsurgical
Altius Peripheral Nerve Stimulation in Amputees After TMR/RPNI
This is a single-center, prospective, within-subject study. This study seeks to enroll a total of 32 prospective subjects who will undergo surgical implantation of the FDA-approved Altius® system.
- Trial name
- NCT07571239
- Testing
- Surgical Implantation
- Where
- United States
- Volunteers
- 32 people
- Sponsor
- NYU Langone Health
Stump Neuroma, Residual Limb Pain
Ultrasound-Guided Radiofrequency Ablation Versus Steroid Injection for Stump Neuroma
This prospective clinical study aims to compare the effectiveness of ultrasound-guided radiofrequency ablation and ultrasound-guided corticosteroid injection in individuals with symptomatic stump neuroma following lower extremity…
- Conditions
- Stump Neuroma, Residual Limb Pain, Lower Extremity Amputation
- Trial name
- NCT07431424
- Testing
- Radiofrequency ablation alone, Corticosteroid Injection
- Where
- Turkey (Türkiye)
- Volunteers
- 26 people
- Sponsor
- Gaziler Physical Medicine and Rehabilitation Education and Research Hospital
Symptomatic Neuroma, Phantom Limb Pain After Amputation
Evaluation of RPNI for Symptomatic Neuromas in Lower Limb Amputees
This prospective, observational cohort study evaluates the long-term outcomes of Regenerative Peripheral Nerve Interface (RPNI) surgery in patients with major lower extremity amputations suffering from symptomatic neuromas.
- Conditions
- Symptomatic Neuroma, Phantom Limb Pain After Amputation, Residual Limb Pain, Neuropathic Pain
- Trial name
- RPNI-AMPUTEE (NCT07420192)
- Testing
- Regenerative Peripheral Nerve Interface (RPNI) Surgery
- Where
- Turkey (Türkiye)
- Volunteers
- 20 people
- Sponsor
- Saglik Bilimleri Universitesi
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
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
Intrathecal, Dexmedetomidine
Intrathecal Dexmedetomidine-Fentanyl Combination Versus Fentanyl Alone as Adjuvant to Bupivacaine in Spinal Anesthesia for Above Knee Amputation in Sarcomas of Lower Extremity
The current work evaluated whether the combination of intrathecal dexmedetomidine and fentanyl provides superior postoperative analgesia to fentanyl alone when administered with hyperbaric bupivacaine.
- Conditions
- Intrathecal, Dexmedetomidine, Fentanyl, Bupivacaine
- Trial name
- NCT07276867
- Testing
- Fentanyl + Dexmedetomidine, Fentanyl
- Where
- Egypt
- Volunteers
- 58 people
- Sponsor
- National Cancer Institute, Egypt
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
Traumatic Amputation of Lower Extremity
Improving Mobility and Function Following Transfemoral Amputation: A Novel Approach to Reverse Volumetric Muscle Loss
The purpose of this study is to investigate the relationship between thigh strength and walking ability and assess if using a blood pressure cuff on the leg improves strength and walking performance.
- Trial name
- NCT05929508
- Testing
- Ischemic Preconditioning
- Where
- United States
- Volunteers
- 30 people
- Sponsor
- University of Illinois at Chicago
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.
Diabetes Mellitus, Claudication, Intermittent
Additional Hyperbaric Oxygen After Lower Extremity Amputation
This study evaluates the effect of additional hyperbaric oxygen therapy after lower extremity amputation. The patients will be randomized after amputation to either a treatment group receiving hyperbaric oxygen therapy, or…
- Conditions
- Diabetes Mellitus, Claudication, Intermittent, Critical Limb Ischemia, Osteomyelitis
- Trial name
- AHOLEA (NCT03594344)
- Testing
- Hyperbaric oxygen therapy
- Where
- 2 sites in Norway
- Volunteers
- 120 people
- Sponsor
- Oslo University Hospital
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
Lower Extremity Amputation
Instrumental Analysis of Walking in People With Osseointegrated Prostheses for Lower Extremity Amputation: Comparative Evaluation With Traditional Socket Prostheses
The currently accepted standard for rehabilitation and mobility following amputation is a socket-mounted prosthesis. Osseointegration is an alternative method that has gradually gained greater acceptance in the last 30 years.
- Trial name
- AStrO-OI (NCT04934839)
- Testing
- Test of standing balance (Equitest System). Test of walking in tied and split conditions on a force-sensorized split-belt treadmill.
- Where
- 2 sites in Italy
- Volunteers
- 8 people
- Sponsor
- Istituto Auxologico Italiano
Diabetes Mellitus, Type 2, Urosepsis
Safety of Sodium-glucose Cotransporter 2 (SGLT2) Inhibitors Among Patients With Type 2 Diabetes
The purpose of this study is to compare the risk of serious adverse events associated with the use of sodium-glucose cotransporter 2 (SGLT2) inhibitors in comparison with the use of dipeptidyl peptidase-4 (DPP-4) inhibitors among…
- Conditions
- Diabetes Mellitus, Type 2, Urosepsis, Diabetic Ketoacidosis, Lower Extremity Amputation
- Trial name
- NCT04017221
- Testing
- Sodium-glucose cotransporter 2 (SGLT2) inhibitors, Dipeptidyl peptidase-4 (DPP-4) inhibitors, Other treatment combinations
- Where
- Canada
- Volunteers
- 1,249,636 people
- Sponsor
- Canadian Network for Observational Drug Effect Studies, CNODES
Lower Extremity Amputation
Community Walking Trials: Comparing Prosthetic Feet
The purpose of the study is to obtain performance measurements and participant feedback about use of an investigational prosthetic foot compared to the participant's usual prosthetic foot.
- Trial name
- NCT03703232
- Testing
- Investigational prosthetic foot
- Where
- United States
- Volunteers
- 31 people
- Sponsor
- University of Washington