Clinical trials: Limb Amputation
Amputations, Diabetes
Clinical Trial of Footwear in Patients With Diabetes
A Seattle VA study indicated lower extremity ulcers preceded 84% of diabetic amputations. Nearly half of the events that ban the causal chain leading to ulcers and amputation were initiated by ill-fitting footwear.
- Conditions
- Amputations, Diabetes, Lower Extremity Ulcers
- Trial name
- NCT00032864
- Sponsor
- US Department of Veterans Affairs
Prosthesis User, Lower Limb Amputation Below Knee (Injury)
Caesar Foot Take-Home Validation Testing
The rationale for this study is to conduct a take-home clinical trial to evaluate the impact of the bimodal Caesar foot in a real-world environment.
- Trial name
- NCT07075198
- Testing
- Caesar Foot
- Where
- United States
- Volunteers
- 18 people
- Sponsor
- Liberating Technologies, Inc.
Post-Amputation Phantom Limb Pain
Cryoanalgesia to Treat Post-Amputation Phantom Limb Pain: A Department of Defense Funded Multicenter Study
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.
- Trial name
- NCT03449667
- Testing
- Cryoneurolysis
- Where
- 6 sites in United States
- Volunteers
- 144 people
- Sponsor
- University of California, San Diego
Transfemoral Amputation, Limb Loss
Effect of a Microprocessor-controlled Prosthetic Knee Joint on K2 Level Ambulators
Microprocessor-controlled knees (MPKs) automatically adjust resistance or damping in the joint to improve swing- and/or stance-phase control as appropriate for the prosthesis user during gait.
- Conditions
- Transfemoral Amputation, Limb Loss, Limb Absence
- Trial name
- MPK-K2 (NCT07103798)
- Testing
- College Park ICON, Conventional NMPK
- Where
- 2 sites in United States
- Volunteers
- 20 people
- Sponsor
- VA Office of Research and Development
Amputation, Prosthesis User
Sonomyographic Upper Limb Prosthetics: A New Paradigm
The vast majority of all trauma-related amputations in the United States involve the upper limbs. Approximately half of those individuals who receive a upper extremity myoelectric prosthesis eventually abandon use of the system…
- Trial name
- NCT05376332
- Testing
- Sonomyographic Prosthesis, Myoelectric direct control prosthesis, Myoelectric pattern recognition prosthesis
- Where
- United States
- Volunteers
- 16 people
- Sponsor
- George Mason University
Amputation
Does Walking Performance Improve When Veterans With Leg Amputations Are Given Visual Feedback?
Previous studies suggest that Veterans with below the knee amputation using passive-elastic or powered prostheses have impaired physical function, which could increase the risk of osteoarthritis, leg/back pain, and…
- Trial name
- NCT03974945
- Testing
- Passive-elastic prosthetic foot, Powered ankle-foot prosthesis
- Where
- United States
- Volunteers
- 12 people, healthy volunteers welcome
- Sponsor
- VA Office of Research and Development
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
Hyperhidrosis
Study to Assess the Efficacy of Botulinum Toxin B (Myobloc) for the Treatment of Prosthesis-associated Sweating
The objective of this study is to determine if Myobloc significantly decreases prosthesis-associated symptomatic sweating in amputees when compared to a saline solution placebo.
- Trial name
- NCT01671800
- Testing
- Botulinum Type B
- Where
- United States
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- Henry M. Jackson Foundation for the Advancement of Military Medicine
Upper Extremity Injury, Upper Extremity Deformities, Congenital
SoftHand Comparison Study
A trial to compare the performance of the SoftHand Pro (SHP) and Ossur i-Limb in people with transradial limb loss over an 8-week period.
- Conditions
- Upper Extremity Injury, Upper Extremity Deformities, Congenital, Amputation, Traumatic, Amputation, Congenital
- Trial name
- NCT05328934
- Testing
- SoftHand Pro, Ossur i-Limb
- Where
- 2 sites in United States
- Volunteers
- 36 people
- Sponsor
- Mayo Clinic
Lower Limb Amputation
Overall Functional Evaluation After Amputation of the Lower Limb; Locomotion, Energy Efficiency and Strategies to Adapt to the Prosthesis
It appears necessary to confront the reality of the contribution of technological progress in the creation of prostheses with the specific features of lower limb amputees.
- Trial name
- PROTEOR (NCT03260530)
- Testing
- Locomotor evaluation, Questionnaires
- Where
- France
- Volunteers
- 26 people
- Sponsor
- Centre Hospitalier Universitaire Dijon
Amputation
Influence Of A Slope Adaptive Foot On Participation Of Veterans With Lower-Limb Amputations
Veterans with below-knee amputations are limited by prosthetic feet that cannot adapt to sloped and uneven terrain. This limitation results in reduced mobility, reduced balance confidence, and a higher risk of falls among some…
- Trial name
- NCT07266077
- Testing
- Fillauer Slope Adaptive Foot, Fillauer Motion Foot SLX
- Where
- United States
- Volunteers
- 30 people
- Sponsor
- VA Office of Research and Development
Amputation
Investigation of Embodiment for Upper Limb Amputees
Today, prosthetic hands are numb. They provide no tactile or proprioceptive sensory information back to the user. The lack of sensory feedback has been shown to reduce the utility of a prosthesis by half.
- Trial name
- NISRL (NCT04578327)
- Testing
- Prosthetic hand, Peripheral Nerve Interface
- Where
- United States
- Volunteers
- healthy volunteers welcome
- Sponsor
- VA Office of Research and Development
Upper Limb Amputation at the Wrist
A Bidirectional MyoKinetic Implanted Interface for Natural Control of Artificial Limbs
This is a European project that it will develop an innovative robotic hand prosthesis, whose movements can be controlled in a natural and intuitive way.
- Trial name
- MYKY (NCT06176482)
- Testing
- Magnetic markers implantation
- Where
- Italy
- Volunteers
- 5 people, healthy volunteers welcome
- Sponsor
- Azienda Ospedaliero, Universitaria Pisana
Amputation, Lower Limb
Quantifying Bone and Skin Movement in the Residual Limb of Individuals With Transtibial Amputation Using Dynamic Stereo X-Ray
Individuals with lower extremity amputation are often challenged by complications that arise from poor prosthetic fit, including movement of the residual limb in the socket, known as pistoning.
- Trial name
- NCT05287646
- Testing
- Suction Suspension First, Elevated Vacuum Suspension First
- Where
- United States
- Volunteers
- 21 people
- Sponsor
- VA Office of Research and Development
Peripheral Artery Disease, Critical Limb Ischemia
Temsirolimus Adventitial Delivery to Improve ANGioplasty and/or Atherectomy Revascularization Outcomes Below the Knee
A multicenter, randomized, double-blind, placebo-controlled trial to evaluate the effect of Temsirolimus Perivascular Injection 0.1 mg/mL on the incidence of ischemia-driven major amputation, clinically driven target lesion…
- Trial name
- TANGO-3 (NCT04433572)
- Testing
- Temsirolimus
- Where
- 2 sites in United States
- Volunteers
- 250 people
- Sponsor
- Mercator MedSystems, Inc.
Gait, Balance
Gait Stability of People With Lower-limb Amputations
The purpose of this study is to evaluate whether there are quantifiable differences in walking stability, as measured by the acceleration of the trunk or the variation in step length, between people with unilateral below-knee…
- Trial name
- NCT00915109
- Where
- Canada
- Volunteers
- 50 people, healthy volunteers welcome
- Sponsor
- Kim Parker
Critical Limb Ischemia, Peripheral Arterial Disease
ALD-301 for Critical Limb Ischemia, Randomized Trial
This study will treat patients with such severe lower leg ischemia or vascular compromise that they have pain at rest. The goal is to compare treatment of the patient's painful disorder by injecting cells into the calf of the leg…
- Conditions
- Critical Limb Ischemia, Peripheral Arterial Disease, Peripheral Vascular Disease
- Trial name
- CLI-001 (NCT00392509)
- Testing
- ALDH-br bone marrow cells vs. mononuclear bone marrow cells
- Where
- 5 sites in United States
- Volunteers
- 20 people
- Sponsor
- Aldagen
Amputation
Personalized Mobility Interventions Using Smart Sensor Resources for Lower-Limb Prosthesis Users
The goal of this research is to analyze data from smartphone-based and wearable sensors, using advanced machine-learning and data-mining techniques, and to combine this information with performance-based measures…
- Trial name
- NCT03930199
- Testing
- Needs-based intervention (physical, psychological, or both)
- Where
- 3 sites in United States
- Volunteers
- 66 people
- Sponsor
- Shirley Ryan AbilityLab
Amputation
Dynamic Management of Excess Residual Limb Pressure With New Smart Socket Technology/Intelligent Prosthetic Socket With Variable Volume and Elevated Vacuum Systems
This study centers around the imaging of internal structures of residual limb by means of modern radiographic imaging techniques (Dynamic Radiography-DRSA).
- Trial name
- SMARTsocket- (NCT01108536)
- Testing
- adaptive prosthetic socket
- Where
- 3 sites in United States, Cyprus
- Volunteers
- 60 people
- Sponsor
- University of Wisconsin, Milwaukee
Lower Limb Amputation Above Knee (Injury)
Decoding Motion Planning Using Cortical Potentials
The team will investigate the user's intention to move by using cortical activity during a sit to stand movement performance in people with a transfemoral amputation and able-bodied individuals.
- Trial name
- NCT04325516
- Testing
- Daily activities
- Where
- Belgium
- Volunteers
- 10 people, healthy volunteers welcome
- Sponsor
- Vrije Universiteit Brussel