Clinical trials: Lower Limb Amputation Below Knee (Injury)
Amputation, Amputation; Traumatic, Leg, Lower
Socket Cooling Effectiveness Take Home 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, Amputation; Traumatic, Leg, Lower, Amputation Stump, Limb; Absence, Congenital, Lower
- Trial name
- NCT04484805
- Testing
- ICE Condition
- Where
- 2 sites in United States
- Volunteers
- 12 people, healthy volunteers welcome
- Sponsor
- Liberating Technologies, Inc.
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
Lower Limb Amputation Below Knee (Injury)
R21: An Easy-to-use, iNtelligent, Affordable LinEr (ENABLE) System for Socket Fit Assessment
Lower limb amputees (LLA) rely on their prosthetic legs to remain active and lead an independent life. For most LLAs, a well-fitted prosthetic socket is the only option to interface with their prosthetic leg, however, it is a…
- Trial name
- ENABLE (NCT05425810)
- Testing
- Apply ENABLE sensing pad, Insert small pads at pressure tolerant locations
- Where
- United States
- Volunteers
- 3 people
- Sponsor
- North Carolina State University
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 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
Lower Limb Amputation Below Knee (Injury)
Restoration of Normative Postural Control
The objective of this proposal is to investigate the effects of training to use direct electromyographic (dEMG) control of a powered prosthetic ankle on transtibial amputees'. The aimed questions to answer: 1.
- Trial name
- NCT06452186
- Testing
- direct EMG controlled prosthetic ankle, PT guided prosthetic training
- Where
- United States
- Volunteers
- 50 people
- Sponsor
- North Carolina State University
Lower Limb Amputation Knee, Lower Limb Amputation Below Knee (Injury)
Validity and Reliability of The 3-Meter Backward Walk Test in Individuals With Lower Limb Amputation
Clinicians are routinely required to make decisions about fall risk among lower limb prosthesis users. For these decisions, clinicians should use valid, reliable, quantitative, and multidimensional measures of balance test for…
- Trial name
- NCT05095584
- Testing
- 3 meter backward walk test
- Where
- Turkey (Türkiye)
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Tezel Yıldırım Şahan
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.
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
Lower Limb Amputation Above Knee (Injury), Lower Limb Amputation Below Knee (Injury)
Virtual Reality Treatment for Phantom Limb Pain
Patients with limb amputations experience the sensation of the missing extremity, which is sometimes coupled with a persistent and debilitating pain in the missing limb, a condition known as phantom limb pain (PLP).
- Conditions
- Lower Limb Amputation Above Knee (Injury), Lower Limb Amputation Below Knee (Injury), Phantom Limb Pain
- Trial name
- NCT03338842
- Testing
- Distractor and Lower limb VR
- Where
- United States
- Volunteers
- 14 people, healthy volunteers welcome
- Sponsor
- University of Pennsylvania
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
Diabetic Foot Disease, Diabetic Foot Infection
Intraosseous Versus Intravenous Vancomycin in Below-Knee Amputation for Ischemic Diabetic Foot
This randomized clinical trial compared two routes of vancomycin administration in patients undergoing below-knee amputation for ischemic diabetic foot infection.
- Conditions
- Diabetic Foot Disease, Diabetic Foot Infection, Diabetic Amputation Foot Wound
- Trial name
- NCT07338773
- Testing
- Intraosseous Vancomycin, Intravenous Vancomycin
- Where
- Turkey (Türkiye)
- Volunteers
- 40 people
- Sponsor
- Başakşehir Çam & Sakura City Hospital
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
Amputation, Lower Limb Amputation Below Knee (Injury)
Prosthetic Performance Enhancement Trial
The purpose of this research is to determine the feasibility of an uneven terrain walking program for lower limb prosthesis users.
- Conditions
- Amputation, Lower Limb Amputation Below Knee (Injury), Lower Limb Amputation Above Knee (Injury), Lower Limb Amputation at Ankle (Injury)
- Trial name
- PROSPER (NCT06419920)
- Testing
- Flat terrain locomotor training, Uneven terrain locomotor training
- Where
- United States
- Volunteers
- 35 people
- Sponsor
- University of Nevada, Las Vegas
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
Lower Limb Amputation Below Knee (Injury)
Comprehensive Evaluation of the Passive Talaris Demonstrator
The passive Talaris Demonstrator (TD) is developed in continuation of previous prototypes. The main goal of the experiment is to evaluate the effectiveness of TD during daily activities.
- Trial name
- NCT05127993
- Testing
- Passive Talaris Demonstrator
- Where
- Belgium
- Volunteers
- 8 people, healthy volunteers welcome
- Sponsor
- Vrije Universiteit Brussel
Lower Limb Amputation Below Knee (Injury)
Auto Control of Volume Management for Limb Loss
The aim of this research is to create a prosthetic system that will automatically adjust the fit of the socket and create a well-fitting prosthesis for people with leg amputations who experience volume fluctuations when using…
- Trial name
- NCT03550118
- Testing
- Adjustable socket
- Where
- United States
- Volunteers
- 104 people
- Sponsor
- University of Washington
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
Lower Limb Amputation Below Knee (Injury)
Wear and Tear Evaluation of New Nike Sport Sole for Runnnig Prosthesis
Running Specific Feet are based on the original Flex-Foot design using the energy storage and release function as the main design feature. Running specific prosthetic feet are intended for running and jogging.
- Trial name
- NCT04787640
- Testing
- Nike Sport Sole
- Volunteers
- 3 people
- Sponsor
- Össur Iceland ehf
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