Clinical trials: Leg Amputation
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
Trans-tibial Limb Loss
Physiologic Range of Step-by-step Variations in Lower Limb Prosthesis Forces During Walking
In human gait there is a certain amount of variation between steps; some considered physiological and owed to variations in environment or posture, and some severe enough to be indicative of gait instabilities that may lead to…
- Trial name
- NCT02234505
- Testing
- Prosthetic alignment perturbation
- Where
- United States
- Volunteers
- 12 people, healthy volunteers welcome
- Sponsor
- University of Pittsburgh
Clinical Practice Guidelines, Lower Limb Amputation Above Knee (Injury)
TeleEducation for Implementing a Clinical Practice Guideline For Amputees
The publication of a Clinical Practice Guideline (CPG) is often not enough for its correct use in the field of health care. There are barriers to the implementation of the CPG recommendations, including those related to the lack…
- Conditions
- Clinical Practice Guidelines, Lower Limb Amputation Above Knee (Injury), Lower Limb Amputation Below Knee (Injury), Lower Limb Amputation Knee
- Trial name
- TEFICA (NCT05601349)
- Testing
- Telehealth-based strategy
- Where
- Colombia
- Volunteers
- 7 people
- Sponsor
- Grupo Rehabilitacion en Salud
Postoperative Pain
Preoperative (Pre-amputation) Cryoanalgesia to Improve Post-amputation Phantom Limb Pain
Investigators will evaluate preamputation cryoanalgesia on pain, mobility, opioid use and general physical and emotional disability using a pilot randomized trial design, to explore the amount and variability of improvement on…
- Trial name
- NCT06284109
- Testing
- Cryoanalgesia
- Where
- United States
- Sponsor
- The Cleveland Clinic
Amputation Stump, Peripheral Vascular Disease With Complications
Comparison Between Postoperative Tubular Dressing and a Vacuum Removable Rigid Dressing After Transtibial Amputation
Comparison of wound healing, edema level, knee range of motion, rate of revision post falls, device application time, time to prosthetic fit, and cost between postoperative soft dressing and a vacuum removable rigid dressing…
- Conditions
- Amputation Stump, Peripheral Vascular Disease With Complications, Edema Leg, Wound Healing Delayed
- Trial name
- EMPAR (NCT03948087)
- Testing
- Vacuum Removable Rigid Dressing (VRRD)
- Volunteers
- 100 people
- Sponsor
- Covenant Health, Canada
Amputation, Wound; Foot
Comparing Wound Complication Following TMA With Aid of Electrospun Fiber Matrix
Transmetatarsal amputation (TMA) patient populations commonly have poor healing outcomes and a large number of complications. There has been little study on the benefits of augmenting a TMA with a synthetic graft substitute.
- Conditions
- Amputation, Wound; Foot, Wound Complication
- Trial name
- NCT06063694
- Testing
- Synthetic electrospun fiber matrix
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- Scripps Health
Amputation, Diabetes Complications
Use of Subtle Vibration to Improve Walking Ability by Lower Limb Amputees
The purpose of this study is to determine if subthreshold vibration, when applied to the residual limb of a lower limb amputee through their prosthetic socket, can sufficiently enhance peripheral sensation to result in an…
- Trial name
- NCT00985881
- Testing
- Custom prosthetic socket with mechanical vibrators (stochastic resonance), Conventional prosthetic socket (current clinical practice)
- Where
- United States
- Volunteers
- 17 people
- Sponsor
- VA Office of Research and Development
Amputation of Lower Limb
Personalized Prosthetic Foot Prescription and Rehabilitation for Veterans With Lower Limb Loss
The goal of clinical trial is to assess an integrated, patient-centered strategy combining user preference-based prosthetic foot prescription and subsequent targeted physical therapy to maximize satisfaction and mobility outcomes…
- Trial name
- OPORP (NCT06844305)
- Testing
- Prosthetic foot, Physical therapy
- Where
- United States
- Volunteers
- 50 people
- Sponsor
- Northwestern University
Phantom Limb Pain, Neuropathic Pain
Intrathecal Dexmedetomidine and Acute Neuropathic Pain After Lower Limb Amputation
This randomized controlled trial evaluated the effect of adding intrathecal dexmedetomidine (10 µg) to hyperbaric bupivacaine (11 mg) for spinal anesthesia in patients undergoing lower limb amputation.
- Conditions
- Phantom Limb Pain, Neuropathic Pain, Lower Limb Amputation
- Trial name
- DEX-RCT (NCT07565662)
- Testing
- Hyperbaric Bupivacaine plus Saline, Hyperbaric Bupivacaine plus Dexmedetomidine
- Where
- Mexico
- Volunteers
- 30 people
- Sponsor
- Universidad Juárez Autónoma de Tabasco
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
Fall Prevention, Balance, Falls
Evaluating Methods to Replicate Stumbles and Slips During Walking
This protocol outlines a study designed to investigate three different methodologies for inducing gait perturbations. Subjects will be divided into two groups: prosthetic users and able-bodied individuals.
- Conditions
- Fall Prevention, Balance, Falls, Amputation of Lower Limb
- Trial name
- NCT07175714
- Testing
- Methodologies to induce gait perturbations
- Where
- 2 sites in Iceland
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- Össur Iceland ehf
Amputation
Prosthetic Limbs After Leg Amputation: Alternative Method of Socket Design
People who have had a leg amputated often choose to use a prosthetic (artificial) leg. This study will evaluate a new method of making prosthetic legs for people who have had an amputation below the knee.
- Trial name
- NCT00061217
- Testing
- Unrectified prosthetic socket, Rectified prosthetic socket
- Where
- United States
- Volunteers
- 59 people
- Sponsor
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
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 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
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.
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
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