Clinical trials: Lower Extremity Amputation
Ambulation With the "Take Home" or Passive Prosthesis, Ambulation With the Motorized Prosthesis in the "Off" Configuration
Investigation of Motorized Lower-limb Prostheses
The goal of this clinical trial is to learn if a motorized prosthesis can improve mobility in individuals with amputation. The main question it aims to answer is: Does motorized prosthesis improve ambulation speed, balance…
- Conditions
- Ambulation With the "Take Home" or Passive Prosthesis, Ambulation With the Motorized Prosthesis in the "Off" Configuration, Ambulation With the Motorized Prosthesis in the "Transparent" Condition, Ambulation With the Motorized Prosthesis in the "Powered" Condition
- Trial name
- NCT07584707
- Testing
- Passive prosthesis, Motorized prosthesis
- Where
- United States
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- Northern Arizona University
Amputation
EmPOWERing Active Seniors With Energy
A pilot study comparing the emPOWER Ankle System to standard carbon fiber prosthetic feet, in active seniors.
- Trial name
- EASE (NCT02958553)
- Testing
- emPOWER Ankle, Subject's own passive prosthesis
- Where
- United States
- Volunteers
- 8 people
- Sponsor
- Otto Bock Healthcare Products GmbH
Prostheses and Implants
Advanced Prosthetic Devices for Lower Limb Amputees
Lower limb amputation is an emerging global health concern. Currently, there are over 1.6 million amputees in the U.S. and around 6000 new amputations are recorded per annum in the UK.
- Trial name
- NCT04197011
- Testing
- prosthetic device
- Where
- United Kingdom
- Volunteers
- 19 people, healthy volunteers welcome
- Sponsor
- Nottingham Trent University
Lower Limb Amputation
Comparative Effectiveness of Socket Casting Methods: Improving Form and Fit
The overall objective is to compare hand casting to standing hydrostatic pressure casting using a water cylinder in persons with lower limb amputation.
- Trial name
- NCT04141748
- Testing
- Symphonie Aqua SystemTM, Hand Casting
- Where
- 3 sites in United States, Italy
- Volunteers
- 80 people
- Sponsor
- Northwestern University
Lower Limb Amputation at Ankle (Injury)
Comparing New Prothesis PROPRIO-FOOT® Versus Usual Prothesis Tasks Tibial Amputees
Evaluate a new porosthetic device in lower limb amputees.
- Trial name
- PROPRIO-FOOT (NCT02501408)
- Testing
- propriofoot prosthesis
- Where
- France
- Volunteers
- 50 people
- Sponsor
- University Hospital, Angers
Phantom Limb Pain
Study to Assess the Efficacy of Direct Observation and Mental Visualization of Foot Movements to Treat Bilateral Lower Limb Phantom Limb Pain
Because bilateral lower extremity amputees do not have an intact limb for use with the mirror, we are now proposing to conduct a pilot trial of two treatments for phantom limb pain (PLP) - direct observation of another person's…
- Trial name
- NCT00639431
- Testing
- direct observation, mental visualization
- Where
- United States
- Volunteers
- 42 people, healthy volunteers welcome
- Sponsor
- Walter Reed Army Medical Center
Foot Ulcer, Diabetic
Treatment Study of Negative Pressure Wound Therapy for Diabetic Foot Wounds
On behalf of a consortium of 19 health insurance companies the Institute for Research in Operative Medicine as part of the University of Witten / Herdecke gGmbH is planning and conducting a clinical study evaluating the efficacy…
- Trial name
- DiaFu (NCT01480362)
- Testing
- Negative Pressure Wound Therapy, Standard Wound Therapy
- Where
- 42 sites in Germany
- Volunteers
- 360 people
- Sponsor
- University of Witten/Herdecke
Lower Limb Amputation
A Pilot RCT to Investigate the Use of a Home-based Nintendo Wii Program for Rehabilitation in Older Adults With Lower Limb Amputation
This is a pilot randomized controlled trial to assess the feasibility of a home-based Nintendo Wii Fit program (Wii.n.Walk) to improve walking capacity in older adults with a lower limb amputation.
- Trial name
- NCT01715662
- Testing
- Wii.n.Walk, Wii Big Brain
- Where
- 3 sites in Canada
- Volunteers
- 28 people, healthy volunteers welcome
- Sponsor
- University of British Columbia
Diabetic Foot, Pressure Ulcer
A Real-World Registry of Chronic Wounds and Ulcers
WOUNDJOURNEY is a longitudinal, real-world, observational registry designed to capture the full clinical course and patient journey associated with chronic wounds and ulcers.
- Conditions
- Diabetic Foot, Pressure Ulcer, Surgical Wound Dehiscence, Vasculitis
- Trial name
- WOUNDJOURNEY (NCT02280733)
- Testing
- Usual care
- Where
- United States
- Volunteers
- 300,000 people
- Sponsor
- U.S. Wound Registry
Peripheral Artery Disease
Efficacy and Safety of Rivaroxaban in Reducing the Risk of Major Thrombotic Vascular Events in Subjects With Symptomatic Peripheral Artery Disease Undergoing Peripheral Revascularization Procedures of the Lower Extremities
The purpose of study was to test whether rivaroxaban added to standard of care treatment, when compared to placebo, had the potential to reduce the incidence of the clinical events related to the clots and complications of the…
- Trial name
- VOYAGER PAD (NCT02504216)
- Testing
- Rivaroxaban (Xarelto, BAY59-7939)
- Where
- 532 sites in United States, Argentina and 32 more
- Volunteers
- 6,564 people
- Sponsor
- Bayer
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
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
Amputation, Prosthesis User
Shared Decision Making Aid for Prosthetic Design
This study is designed to learn more about decision making for prosthetic design, with the goal of producing a decision making aid for prosthetic design decisions.
- Trial name
- D-MAP (NCT04536025)
- Testing
- Qualitative focus group interviews, Qualitative semi-structured interviews
- Where
- United States
- Volunteers
- 66 people
- Sponsor
- University of Colorado, Denver
Amputation; Traumatic, Leg, Lower
Whole-body Vibration Without Visual Feedback on Postural Steadiness in Unilateral Trans-femoral Traumatic Amputees
This study will investigate the effects of Whole-body vibration without visual feedback on postural steadiness in unilateral trans-femoral traumatic amputees.
- Trial name
- NCT06284733
- Testing
- Whole-body vibration plus conservative care, conservative care
- Where
- Egypt
- Volunteers
- 115 people
- Sponsor
- MTI University
Diabetic Foot Ulcers, Equinus Deformity
Determination of the Pathophysicologic Collagen Changes in the Diabetic Achilles Tendon
This is a pilot study examining tendon collagen, collagen cross-linking, and markers of tendon extracellular matrix metabolism in the Achilles tendon of diabetic patients with ulcerations and amputations of the lower extremity.
- Trial name
- NCT01382628
- Where
- United States
- Volunteers
- 10 people
- Sponsor
- Georgetown University
Acquired Absence of Lower Limb, Scar Condition and Fibrosis of the Skin
LASER Pilot Project
Veterans who use prosthetic limbs commonly suffer from skin problems such as scars that create discomfort and pain to the point that wearing the prosthesis is no longer tolerable.
- Trial name
- LASER (NCT05966636)
- Testing
- Fractional CO2 Laser Ablative Resurfacing
- Where
- 2 sites in United States
- Volunteers
- 10 people, healthy volunteers welcome
- Sponsor
- VA Office of Research and Development
Phantom Limb Pain
Massage Therapy for Phantom Limb Pain: Feasibility and Pilot Study
Massage therapy is a treatment self-reported by those with phantom limb pain (PLP) as moderately to extremely effective, but no research to date has been specifically designed to examine such efficacy or effectiveness in this…
- Trial name
- NCT03372668
- Testing
- massage therapy combined with components of mirror therapy
- Volunteers
- 3 people
- Sponsor
- Indiana University
Diabetic Foot Ulcer, Diabetes
Hyperbaric Oxygen Therapy in Diabetics With Chronic Foot Ulcers and Improvement of Quality of Life
This study evaluated the effect of hyperbaric oxygen therapy (HBOT) on wound healing, inflammation index, glycemic control, amputation rate, survival rate of tissue, bacterial wound cultures, and quality of life (QOL) in diabetic…
- Trial name
- NCT02328508
- Testing
- Hyperbaric oxygen therapy
- Volunteers
- 38 people
- Sponsor
- Chen-Yu Chen
Amputation, Diabetic Foot
The Association of Cardiac Valve Calcification and 1-year Mortality After Lower-extremity Amputation in Diabetic Patients
The goal of this observational study is to learn about the association between cardiac valve calcification and the 1-year mortality after lower-extremity amputation in diabetic patients.
- Conditions
- Amputation, Diabetic Foot, Valve Disease, Aortic, Valve Heart Disease
- Trial name
- NCT06079008
- Testing
- calcified cardiac valve
- Volunteers
- 96 people
- Sponsor
- Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
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