Clinical trials: Lower Limb Amputation Below Knee
Lower Limb Amputation Below Knee, Diabetes (DM)
Skin Temperature Perception and Prosthetic Thermoregulation
To protect against excessive body temperatures, local thermoregulatory mechanisms include temperature sensory nerves (responsive to warm or cool stimuli) and vasomotors (muscles that constrict or dilate blood vessels).
- Conditions
- Lower Limb Amputation Below Knee, Diabetes (DM), Skin Temperature Change, Vascular Reactivity
- Trial name
- NCT07215442
- Testing
- Warming stimulus starting at 30 C initial temperature, Warming stimulus starting at 32 C initial temperature, Warming stimulus starting at 34 C initial temperature
- Where
- United States
- Volunteers
- 56 people, healthy volunteers welcome
- Sponsor
- VA Puget Sound Health Care System
Transtibial Amputation - Unilateral, Lower Limb Amputation Below Knee
Prosthetic Satisfaction, Body Image, and ICF Outcomes After Amputation
Lower limb amputation affects not only physical mobility but also psychological well-being, body perception, and involvement in daily and social life.
- Conditions
- Transtibial Amputation - Unilateral, Lower Limb Amputation Below Knee, Body Image, Activities of Daily Living
- Trial name
- ICF (NCT07385859)
- Testing
- No intervention (observational study)
- Where
- Turkey (Türkiye)
- Volunteers
- 27 people
- Sponsor
- Ondokuz Mayıs University
Phantom Limb Pain After Amputation, Lower Limb Amputation Above Knee
Clinical Application Observation on the Evaluation of Phantom Limb Pain With the Suralis System
This study tests whether a vibration-based feedback device (Suralis) can reduce phantom limb pain in people with lower-leg amputations over 3 weeks.
- Conditions
- Phantom Limb Pain After Amputation, Lower Limb Amputation Above Knee, Lower Limb Amputation Below Knee, Lower Limb Amputation Knee
- Trial name
- NCT07324109
- Testing
- Vibrotactile sensory feedback
- Where
- Germany
- Volunteers
- 20 people
- Sponsor
- Median
Peripheral Arterial Disease, Peripheral Vascular Disease
The Effect of Ischemic Conditioning on Strength and Ambulation in Subjects with PAD
Lower limb amputation is common in the United States, with approximately 150,000 amputations annually. Most individuals walking with a prosthesis demonstrate asymmetrical loading-i.e., they favor the amputated side by placing…
- Conditions
- Peripheral Arterial Disease, Peripheral Vascular Disease, Amputation, Lower Limb Amputation Knee
- Trial name
- NCT04937179
- Testing
- Ischemic Conditioning High - Active Comparator
- Where
- United States
- Volunteers
- 21 people
- Sponsor
- University of Illinois at Chicago
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 Limb Amputation Below Knee (Injury)
Human-Prosthetic Interaction: Brain & Technology After Lower-Limb Loss
This study evaluates brain neuroplasticity and functional performance in people with unilateral lower limb amputation.
- Trial name
- HumanIT (NCT05818410)
- Testing
- Prosthetic device (Lunaris), No prosthetic device, Prosthetic device (Sach foot)
- Where
- Belgium
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- Vrije Universiteit Brussel
Stroke, Parkinson Disease
C-STAR Movement Database
The purpose of this study is to develop a database that contains movement and rehabilitation-related data collected through the use of wearable sensors and video.
- Conditions
- Stroke, Parkinson Disease, Lower Limb Amputation Above Knee (Injury), Lower Limb Amputation Below Knee (Injury)
- Trial name
- NCT05471375
- Testing
- Database Entry
- Where
- United States
- Volunteers
- 250 people
- Sponsor
- Shirley Ryan AbilityLab
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
Amputation of Lower Limb Below Knee
Evaluation of High-Performance, Customized, Rapidly-Manufacturable Prosthetic Feet That Provide Improved Mobility
The purpose of this research is to design a high-performance, customized, and rapidly- manufacturable passive prosthetic foot for use in the United States.
- Trial name
- NCT05265403
- Testing
- Commercially-available energy storage and return prosthetic foot, MIT-Lower Leg Trajectory Error (LLTE) customized prosthetic feet
- Where
- United States
- Volunteers
- 40 people
- Sponsor
- Massachusetts Institute of Technology
Amputation, Lower Limb
Virtual Reality in the Rehabilitation in Patients With Lower Limb Amputation.
The goal of this clinical trial is to test the impact of virtual reality on rehabilitation for the patients after a major amputation.
- Conditions
- Amputation, Lower Limb, Rehabilitation, Activities of Daily Living
- Trial name
- NCT05773560
- Testing
- virtual reality rehabilitation
- Where
- Germany
- Volunteers
- 20 people
- Sponsor
- University Hospital Erlangen
Lower Limb Amputation Below Knee (Injury), Diurnal Residual Limb Fluid Volume Fluctuation
An Automatically Adjusting Prosthetic Socket for People With Transtibial Amputation
People with leg amputations often experience daily changes in the size (volume) of their residual limb. These daily changes can cause a prosthesis to fit poorly. They can also cause limb problems like pain or skin breakdown.
- Trial name
- NCT05124652
- Testing
- Auto Adjusting Prosthesis
- Where
- United States
- Volunteers
- 100 people, healthy volunteers welcome
- Sponsor
- University of Washington
Wound Healing, Lower Extremity Amputation
Pilot Study to Assess the Use of Spy Elite for Assessment of Amputation Healing
The purpose of the study is to evaluate the use of the SPY Elite System to assess real-time tissue perfusion of lower extremity amputation sites and to develop parameters to predict healing of amputations at the time of surgery.
- Conditions
- Wound Healing, Lower Extremity Amputation, Above Knee Amputation, Below Knee Amputation
- Trial name
- NCT02440295
- Testing
- Lower Extremity Amputation, SPY Elite Imaging System, Indocyaine Green
- Where
- United States
- Volunteers
- 18 people
- Sponsor
- Corewell Health West
Behavior, Amputation
Self-Management for Amputee Rehabilitation Using Technology.
Lower Limb Amputations (LLAs) are a substantial burden on the Canadian health services with nearly 50,000 cases reported between 2006 and 2011.
- Conditions
- Behavior, Amputation, Lower Limb Amputation Above Knee (Injury), Lower Limb Amputation Below Knee (Injury)
- Trial name
- SMART (NCT04953364)
- Testing
- SMART, Control
- Where
- Canada
- Volunteers
- 82 people, healthy volunteers welcome
- Sponsor
- University of British Columbia
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
Lower Limb Amputation Below Knee (Injury)
Influence of Socket Volume on Prosthesis Performance
The purpose of this study is to investigate how residual limb fluid volume, gait, prosthesis use, perceived comfort, and satisfaction with the prosthesis are affected by size of the prosthetic socket.
- Trial name
- CAD (NCT02124915)
- Where
- United States
- Volunteers
- 9 people
- Sponsor
- University of Washington
Amputation; Postoperative, Sequelae
Hyperbaric Oxygen and Outcome After Below Knee Amputations
This study is being conducted to assess the utility of hyperbaric oxygen as an adjunctive treatment to reduce postoperative complications.
- Trial name
- NCT04717557
- Testing
- Hyperbaric Oxygen
- Where
- United States
- Volunteers
- 4 people
- Sponsor
- Duke University
Lower Limb Amputation Below Knee (Injury)
Effects of Prosthesis Training on Pain, Prosthesis Satisfaction and Ambulatory Status of Lower Limb Amputees
The objective of the study is to assess the effects of prosthesis training with and without phantom exercises on pain, prosthesis satisfaction and ambulatory status of lower limb amputees treated with prosthesis training, phantom…
- Trial name
- NCT06013631
- Testing
- Prosthesis Training, Phantom Exercises
- Where
- Pakistan
- Volunteers
- 50 people
- Sponsor
- University of Lahore
Lower Limb Amputation Below Knee (Injury), Lower Limb Amputation Above Knee (Injury)
Women's-Specific Footwear With Prosthetic Feet
The purpose of this study is to address footwear challenges unique to women prosthesis users. Comparing the effectiveness of different footwear and prosthesis combinations will help guide clinical decision making regarding the…
- Trial name
- WSF (NCT03673371)
- Testing
- Questionnaire
- Where
- United States
- Volunteers
- 100 people
- Sponsor
- Minneapolis Veterans Affairs Medical Center
Phantom Limb Pain, Phantom Pain
VR to Evaluate Phantom Limb Pain
The objective of this study is to develop a virtual rehabilitation system that can be used to effectively treat Phantom Limb Pain (PLP) within the research setting and for at-home use by individuals with upper and lower extremity…
- Conditions
- Phantom Limb Pain, Phantom Pain, Phantom Sensation, Phantom Limb Syndrome With Pain
- Trial name
- NCT05915065
- Testing
- Coapt Phantom Limb Pain Management System
- Where
- United States
- Volunteers
- 48 people
- Sponsor
- Shirley Ryan AbilityLab
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