Clinical trials: Lower Leg Amputations
Amputation; Traumatic, Leg, Lower
Transtibial Osseointegration
Purpose: Aim 1: Quantify soft tissue complications and infections of service members with transtibial amputations treated with OPRA OI and compare them to transfemoral OI service members.
- Trial name
- TOSS (NCT06636136)
- Testing
- OPRA
- Where
- 2 sites in United States
- Volunteers
- 30 people
- Sponsor
- Walter Reed National Military Medical Center
Amputation, Amputation; Traumatic, Leg, Lower
Clinical Outcomes With Passive MPKs vs. Powered Prosthetic Knees
The goal of this proposed project is to gather community-based data from the K4-level Transfemoral Amputee (TFA) population to aid in evidence-based prescription of powered prosthetic knees (i.e., choosing the right device to…
- Conditions
- Amputation, Amputation; Traumatic, Leg, Lower, Limb; Absence, Congenital, Lower, Prosthesis User
- Trial name
- NCT05267639
- Testing
- Power Knee
- Where
- 2 sites in United States
- Volunteers
- 13 people, healthy volunteers welcome
- Sponsor
- Liberating Technologies, Inc.
Infections, Infected Wound
PO vs IV Antibiotics for the Treatment of Infected Nonunion of Fractures After Fixation
This is a Phase III clinical randomized control trial to investigate differences between patient with an infected nonunion treated by PO vs. IV antibiotics.
- Conditions
- Infections, Infected Wound, Nonunion of Fracture, Injury Leg
- Trial name
- POvIV2 (NCT05699174)
- Testing
- Standard of Care PO (oral) antibiotics, Standard of Care Intravenous (IV) antibiotics
- Where
- 13 sites in United States
- Volunteers
- 250 people
- Sponsor
- Major Extremity Trauma Research Consortium
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
Amputation, Prosthesis User
Effects of Microprocessor-controlled Prosthetic Knees on Fall-related Health Outcomes in Limited Community Ambulators
The goal of this study is to find out if using microprocessor-controlled prosthetic knees (MPKs), prosthetic knees with a built-in computer, improves health outcomes related to falls in adults who use above-knee prostheses.
- Conditions
- Amputation, Prosthesis User, Amputation; Traumatic, Leg: Thigh, Between Hip and Knee, Limb; Absence, Congenital, Lower
- Trial name
- NCT06937242
- Testing
- Ottobock C-Leg 4 Microprocessor Knee, Ottobock Kenevo
- Where
- United States
- Volunteers
- 100 people
- Sponsor
- Hanger Institute for Clinical Research and Education, LLC
Anesthesia, Amputation; Traumatic, Leg, Lower
Anaesthetic Technique for Minor Lower Limb Amputation Surgery (ATLLAS)
Major lower limb amputation is recognised as a significant cause of morbidity and mortality. In the United Kingdom, 30-day in-hospital mortality is up to 8.7%.
- Trial name
- ATLLAS (NCT07244627)
- Where
- United Kingdom
- Volunteers
- 300 people
- Sponsor
- University Hospitals of North Midlands NHS Trust
Amputation, Amputation; Traumatic, Leg, Lower
A Comparative Assessment of Transfemoral Prosthetic Sockets
The objective of the proposed work is to enhance understanding of the potential benefits of adjustable sockets and inform clinical decision making.
- Trial name
- NCT04038580
- Testing
- Laminated Socket, Quatro, Infinite Socket
- Where
- 2 sites in United States
- Volunteers
- 29 people
- Sponsor
- University of Michigan
Amputation, Amputation; Traumatic, Leg, Lower
Clinical Outcomes With Non-Powered vs. Powered Prosthetic Knees by K2-level Amputees
The goal of this proposed project is to gather community-based data from the K2-level Transfemoral Amputee (TFA) population to aid in evidence-based prescription of powered prosthetic knees (i.e., choosing the right device to…
- Conditions
- Amputation, Amputation; Traumatic, Leg, Lower, Limb; Absence, Congenital, Lower, Prosthesis User
- Trial name
- NCT06194838
- Testing
- Ossur Power Knee, Reboocon Intuy Knee
- Where
- United States
- Volunteers
- 26 people
- Sponsor
- Liberating Technologies, Inc.
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
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.
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, 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; 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
Amputation, Amputation, Traumatic
No Power Bionic Lower Extremity Prosthesis
Typically people need separate prosthetic feet for running and walking. To bridge the gap, this study will test the Compliant Adaptive Energy Storage and Return (CAESAR) foot.
- Conditions
- Amputation, Amputation, Traumatic, Amputation; Traumatic, Leg, Lower
- Trial name
- NCT04070105
- Testing
- Compliant Adaptive Energy Storage and Return Foot, AllPro
- Where
- United States
- Volunteers
- 6 people
- Sponsor
- University of Michigan
Amputation, Amputation; Traumatic, Leg, Lower
Evaluation of Functionality of Amputees According to the Medicare Functional K Classification System
The aim of our study is; To evaluate the functionality of lower extremity unilateral amputees, to ensure that the results of the Medicare Functional K Classification System, which provides subjective data for the evaluator…
- Trial name
- NCT06293443
- Testing
- Lower extremity unilateral amputee
- Where
- Turkey (Türkiye)
- Volunteers
- 24 people
- Sponsor
- Medipol University
Amputation, Amputation; Traumatic, Leg, Lower
Interventional Study on the Evaluation of Functionality, Safety of a Robotic Prosthesis for Transtibial Amputations
The goal of this multicenter interventional pilot is to verify the functionality of a prosthesis for trans-tibial amputees. The main question it aims to answer are: Is to verify the technical functionality, safety and reliability…
- Trial name
- NCT06161961
- Testing
- WRL TTP
- Where
- Italy
- Volunteers
- 7 people
- Sponsor
- Fondazione Don Carlo Gnocchi ETS
Amputation, Dysmelia
Physical Activity and Sports for People With Special Needs
Purpose of this study was to assess the balance level of highly qualified amputee football players in relation to their sports level, training experience, position on the pitch, as well as the type of amputation/dysfunction and…
- Conditions
- Amputation, Dysmelia, Leg; Deformity, Congenital
- Trial name
- NCT05778799
- Testing
- Balance test
- Where
- Poland
- Volunteers
- 66 people, healthy volunteers welcome
- Sponsor
- Józef Piłsudski University of Physical Education
Leg Lower Amputation, Traumatic Amputation
The Injury and Its Consequences in the Sports Lower Limb Amputee
This study was motivated by the lack of data in the literature on the injury of the major lower limb amputee playing sports and its socio-professional impact. It aims to study sports-related injuries in lower limb amputees.
- Trial name
- PREV'AMP SPORT (NCT05059886)
- Testing
- completion of a questionnaire on the practice of sports and possible injuries
- Where
- France
- Volunteers
- 45 people
- Sponsor
- Centre Hospitalier Universitaire de Nīmes
Lower Leg Amputations
Prosthetic Use, Mobility and Daily Functioning
The goal of the project is to explore which elements of rehabilitation that influence mobility in new and experienced unilateral lower-limb amputees.
- Trial name
- ProMob (NCT04904003)
- Testing
- Rehabilitation Intervention
- Where
- 2 sites in Norway
- Volunteers
- 60 people
- Sponsor
- Oslo Metropolitan University
Amputation; Traumatic, Leg, Lower
Design, Prototyping, and Testing of a Robotic Prosthetic Leg
The purpose of this graduate student research study is to test that a specifically designed and novel robotic prosthetic leg (RPL) is feasible, safe and improves symmetry, efficiency, and metabolic function during sit-to-stand…
- Trial name
- NCT04616378
- Testing
- Phase 2 Prescribed Prosthesis, Phase 2 Robotic Prosthetic Leg, Phase 3 No Prosthesis
- Where
- United States
- Volunteers
- 2 people, healthy volunteers welcome
- Sponsor
- Loma Linda University