Clinical trials: Lower-Limb Amputation
Amputation, Traumatic Amputation
Study on the Functionality, Safety and Reliability of a Robotic Prosthesis for the Lower Limb At the Transfemoral Level
The goal of this multicenter interventional pilot is to verify the functionality of a prosthesis for trans-femoral amputees. The main question it aims to answer are: Is to verify the technical functionality, safety and…
- Conditions
- Amputation, Traumatic Amputation, Leg Injury, Lower Limb Injury
- Trial name
- MOTU-ATP (NCT06284005)
- Testing
- WRL ATP
- Where
- Italy
- Volunteers
- 4 people
- Sponsor
- Fondazione Don Carlo Gnocchi ETS
Amputation, Ultrasonography
Core Muscle Function and Postural Control in Lower Extremity Amputees
The primary aim of this study is to determine the effect of amputation on core muscle groups by comparing core muscle thickness in individuals with lower extremity amputation to both their intact side and a healthy control group…
- Conditions
- Amputation, Ultrasonography, Postural Control, Balance
- Trial name
- usg (NCT07875075)
- Where
- Turkey (Türkiye)
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- Hacettepe 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
Perineural, Methylene Blue
Perineural Methylene Blue Infusion in Lower Limb Amputation Surgery
This prospective randomized controlled study will be conducted to evaluate the analgesic effect of continuous perineural infusion of methylene blue with bupivacaine on acute postoperative pain and to evaluate its preventive role…
- Conditions
- Perineural, Methylene Blue, Lower Limb Amputation
- Trial name
- NCT05830630
- Testing
- Bupivacaine methylene blue, bupivacaine saline
- Where
- Egypt
- Volunteers
- 72 people, healthy volunteers welcome
- Sponsor
- Tanta University
Diabetic Foot Infection, Diabetic Foot
Multi-center Study to Assess Safety, Tolerability and Efficacy of Topical Pravibismane in Moderate DFI Patients
This is a randomized, open label, controlled, multi-center study to assess safety, tolerability, and efficacy of adjunctive treatment with topically applied pravibismane (MBN-101) in patients with moderate diabetic foot…
- Trial name
- NCT05174806
- Testing
- Topical Pravibismane, Standard of Care
- Where
- 7 sites in United States
- Volunteers
- 47 people
- Sponsor
- Microbion Corporation
Low Back Pain
Personalisation of Prosthetic Care for Lower- Limb Amputees
The global rise in lower-limb amputations is mainly due to diabetes and vascular complications. Amputations cause serious physical and psycho-social disabilities which impair locomotion and compromise patients quality of life.
- Trial name
- NCT06243549
- Where
- 2 sites in United Kingdom
- Volunteers
- 30 people
- Sponsor
- University of Bath
Lower Limb Amputation, Prosthesis Users
Dual-Task Balance Training in Traumatic Lower-Limb Prosthesis Users
This randomized controlled trial will evaluate the effectiveness of dual-task balance training on balance, mobility, and mental health among traumatic lower-limb prosthesis users in the Gaza Strip.
- Conditions
- Lower Limb Amputation, Prosthesis Users, Balance Impairment, Mobility Limitations
- Trial name
- DTBT-LLA (NCT07706452)
- Testing
- Dual-Task Balance Training, Standard Rehabilitation
- Where
- Palestinian Territories
- Volunteers
- 63 people
- Sponsor
- Al-Azhar University - Gaza
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
Amputation
Comparative Study Evaluating the Mobility of Transtibial Amputee Patients Using the PRO-FLEX PIVOT® Foot Versus a Class III Energy Storing and Returning (ESAR) Prosthetic Foot.
The PRO-FLEX PIVOT® is ESAR prosthetic foot with an innovative technology built around three pillars: 1. The PIVOT technology: three axes of rotation (upper support, main pivot and lower support) at the ankle, which allow both a…
- Trial name
- DEFI (NCT06627361)
- Testing
- PRO-FLEX PIVOT Foot evaluation, Class III ESAR Foot evaluation
- Where
- France
- Volunteers
- 30 people
- Sponsor
- Össur Iceland ehf
Amputation; Traumatic, Leg, Lower
Tap Dance for Adults With Lower Limb Amputation
The goal of this study is to determine whether it is possible for people with lower limb amputation (LLA) to perform adapted tap dance, whether an adapted tap dance program would be enjoyable, and whether it may improve balance…
- Trial name
- NCT06334146
- Testing
- Tap dance program
- Where
- United States
- Volunteers
- 3 people
- Sponsor
- University of Nevada, Las Vegas
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
Traumatic Amputation of Lower Extremity
Functional Electrical Stimulation Use in Trans-tibial Amputations
The purpose of this study is to demonstrate the efficacy of functional electrical stimulation (FES) for trans-tibial amputees. The investigators aim to demonstrate that providing three months of FES intervention will increase…
- Trial name
- NCT02931396
- Testing
- FES
- Where
- United States
- Volunteers
- 20 people
- Sponsor
- Alicia Koontz
Foot Ulcers, Osteomyelitis
Investigation of the Use of Hyperspectral Imaging in Foot Surgery Patients
To investigate novel advanced imaging techniques (hyperspectral imaging) that could enable clinicians to determine the degree and effectiveness of blood flow to tissues during surgery.
- Conditions
- Foot Ulcers, Osteomyelitis, Amputation
- Trial name
- HSI (NCT03787862)
- Where
- 2 sites in United States
- Sponsor
- University of Texas Southwestern Medical Center
Diabetes Mellitus, Amputation Stumps
Phototherapy in DM Amputation Ulcers.
Diabetes mellitus is a major public health problem and it is estimated that 300 million individuals will be affected by the year 2030.
- Conditions
- Diabetes Mellitus, Amputation Stumps, Diabetic Foot
- Trial name
- NCT02883751
- Testing
- LED, Control group
- Where
- Brazil
- Sponsor
- University of Nove de Julho
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
Prosthesis, Lower Limb Amputation Knee
Clinical and Functional Assessment of Patients With Transfemoral Amputation Treated With Osteointegrated Implant
Limb amputation is a traumatic event that significantly reduces the ability to perform daily activities, impairs mobility, and lowers quality of life.
- Conditions
- Prosthesis, Lower Limb Amputation Knee, Amputation; Traumatic, Leg, Lower
- Trial name
- OSTEO-OUTCOME (NCT06737770)
- Testing
- osseointegrated surgery for transfemoral amputation
- Where
- Italy
- Volunteers
- 15 people
- Sponsor
- Istituto Ortopedico Rizzoli
Diabetes Mellitus
Assessing Diabetic Foot Ulcer Microcirculation With High-frequency Contrast Enhanced Ultrasound
The objective of this observational study is to investigate and validate the utility of high-frame-rate ultrasound imaging technology for dynamic observation of the blood perfusion process at the site of ulcer wounds in…
- Trial name
- NCT06309082
- Testing
- Amputation, Debridement
- Where
- China
- Volunteers
- 100 people
- Sponsor
- First Affiliated Hospital of Wenzhou Medical University
Amputation
A Client-Based Outcome System for Individuals With Lower Limb Amputation
Standardized outcome measures can be used to document patient health outcomes and improve treatment of those requiring prosthetic and orthotic (O\&P) services.
- Trial name
- NCT01750372
- Where
- 2 sites in United States
- Volunteers
- 1,572 people
- Sponsor
- University of Washington
Diabetic Foot, Gangrene; Limb
MetaMet: Bone Cutter Versus Bone Saw for Ray Amputation
Toe amputation is a commonly performed operation for infection and/or ischaemia (tissue death due to lack of blood flow). However, a large number of patients having this surgery ultimately require further amputation due to poor…
- Conditions
- Diabetic Foot, Gangrene; Limb, Wound Infection, Wound Healing Delayed
- Trial name
- MetaMet (NCT05804565)
- Testing
- Bone Saw, Bone Cutter
- Where
- Ireland
- Volunteers
- 40 people
- Sponsor
- University College Hospital Galway
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