Clinical trials: Lower Extremity Amputation
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
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
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.
Critical Limb Ischemia, Peripheral Arterial Disease
ALD-301 for Critical Limb Ischemia, Randomized Trial
This study will treat patients with such severe lower leg ischemia or vascular compromise that they have pain at rest. The goal is to compare treatment of the patient's painful disorder by injecting cells into the calf of the leg…
- Conditions
- Critical Limb Ischemia, Peripheral Arterial Disease, Peripheral Vascular Disease
- Trial name
- CLI-001 (NCT00392509)
- Testing
- ALDH-br bone marrow cells vs. mononuclear bone marrow cells
- Where
- 5 sites in United States
- Volunteers
- 20 people
- Sponsor
- Aldagen
Critical Limb Ischemia, Critical Lower Limb Ischemia
PROMISE II: Percutaneous Deep Vein Arterialization for the Treatment of Late-Stage Chronic Limb-Threatening Ischemia
The LimFlow System is intended for endovascular, minimally invasive procedures in patients who have a clinical diagnosis of chronic limb-threatening ischemia and who have been determined to have no surgical or endovascular…
- Conditions
- Critical Limb Ischemia, Critical Lower Limb Ischemia, Peripheral Artery Disease, Peripheral Arterial Disease
- Trial name
- PROMISE (NCT03970538)
- Testing
- LimFlow System
- Where
- 21 sites in United States, Puerto Rico
- Volunteers
- 105 people
- Sponsor
- LimFlow, Inc.
Amputation Stumps, Amputees
Moisture Management Liner Effectiveness 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 Stumps, Amputees, Amputation, Lower Limb Deformities, Congenital
- Trial name
- NCT04427007
- Testing
- Moisture Management Liner, Control Liner
- Where
- United States
- Volunteers
- 2 people, healthy volunteers welcome
- Sponsor
- Liberating Technologies, Inc.
Amputation Stumps, Pain
2PX (Topical Strontium Chloride Hexahydrate) in Patients With Post-Amputation Stump Pain.
The objective of this study is to investigate the analgesic effect of topical strontium chloride in stump pain, and to prospectively determine other efficacy and safety measures of topical strontium chloride in stump pain.
- Trial name
- NCT00592098
- Testing
- Strontium chloride hexahydrate
- Where
- Norway
- Volunteers
- 22 people
- Sponsor
- SantoSolve AS
Diabetic Foot
Trial of Vacuum Assisted Closure® Therapy in Amputation Wounds of the Diabetic Foot
The purpose of this study is to compare the effectiveness of Vacuum Assisted Closure® (V.A.C.®) Therapy to moist wound therapy of amputation wounds of the diabetic foot.
- Trial name
- NCT00224796
- Testing
- V.A.C. ® System
- Volunteers
- 146 people
- Sponsor
- KCI USA, Inc
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
Lower Limb Amputation
Evaluation of Limb Health Associated With a Prosthetic Vacuum Socket System
The purpose of the study is to evaluate residual limb circulation and skin health associated with the use of a prosthetic vacuum socket. A conventional non-vacuum prosthetic socket will be compared to a vacuum prosthetic socket.
- Trial name
- NCT01839123
- Testing
- Prosthetic Suction or Pin Socket, Prosthetic LimbLogic Vacuum Socket
- Where
- 2 sites in United States
- Volunteers
- 10 people, healthy volunteers welcome
- Sponsor
- Ohio Willow Wood
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
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.
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
Amputation of Lower Limb, Prosthesis
LIMBER UniLeg: Rapid, On-demand, and Scaled-up Manufacturing of Customized Transtibial Prosthetic Legs for Amputees
The LIMBER UniLeg, a 3D printed single-piece transtibial prosthetic limb, is sufficiently equivalent to traditional passive prosthetic limbs (no motors or sensors), while reducing the cost and time of manufacturing and enabling…
- Conditions
- Amputation of Lower Limb, Prosthesis, Non-inferiority Trial of Prothesis
- Trial name
- NCT06648798
- Testing
- Limber Limb
- Where
- 2 sites in United States
- Volunteers
- 30 people
- Sponsor
- LIMBER Prosthetics & Orthotics Inc
Critical Limb Ischemia
Autologous Adipose-Derived Stromal Cell Delivered Via Intramuscular Injections for the Treatment of Critical Limb Ischemia
This is an open-label, non-randomized, multi center, patient sponsored study of Adipose-Derived Stromal Cell (ASC) implantation via intramuscular injections in patients who have critical limb ischemia not amenable for…
- Trial name
- NCT02099500
- Testing
- Liposuction, Stem Cell Injection
- Where
- United States
- Sponsor
- Ageless Regenerative Institute
Lower Limb Amputation Above Knee (Injury)
C-Leg 3 and C-Leg 4 Study in Transfemoral Amputees
The aim of this post-market study is to confirm that the microprocessor controlled prosthetic knee components (C-Leg 3 and C-Leg 4) in comparison to mechanical knee joints can bring additional benefit to the users primarily on…
- Trial name
- NCT02765035
- Testing
- C-Leg 4, C-Leg 3
- Where
- 2 sites in Austria, Belgium
- Volunteers
- 18 people
- Sponsor
- Otto Bock Healthcare Products GmbH
Peripheral Vascular Disease
Efficacy/Safety of Ecraprost in Lipid Emulsion for Treatment of Critical Leg Ischemia Due to Peripheral Arterial Disease
Ecraprost in lipid emulsion is being developed for the treatment of Critical leg ischemia (CLI), which is the most severe form of peripheral arterial disease (PAD); This trial is designed to assess the efficacy and safety of the…
- Trial name
- NCT00059657
- Testing
- Ecraprost in lipid emulsion
- Where
- 22 sites in United States, United Kingdom
- Volunteers
- 280 people
- Sponsor
- Tanabe Pharma Corporation
Diabetic Foot Ulcer, Dehiscence of Amputation Stump
Kerecis Omega3 Wound Plus SOC vs. SOC Alone in Treating Severe Diabetic Foot Ulcers and Forefoot Amputations
This is a prospective, multi-national, multi-centre, randomized, non-blinded (photo evaluation is blinded), controlled clinical investigation in patients suffering from diabetic wounds reaching to tendon, bone, or joint.
- Conditions
- Diabetic Foot Ulcer, Dehiscence of Amputation Stump, Amputation
- Trial name
- Odinn (NCT04257370)
- Testing
- Kerecis™ Omega3 Wound, Standard of care
- Where
- France
- Volunteers
- 260 people
- Sponsor
- Kerecis Ltd.
Amputation Stump, Amputation
Moisture Management Liner At-Home Evaluation
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 unbreathable and non-thermally conductive materials that can create a warm…
- Conditions
- Amputation Stump, Amputation, Amputees, Lower Limb Deformity
- Trial name
- NCT05124873
- Testing
- Moisture Management Liner
- Where
- United States
- Volunteers
- 1 people
- Sponsor
- Liberating Technologies, Inc.
Diabetes Mellitus, Type 2
Sodium-glucose Co-transporter 2 (SGLT2) Inhibitor Risk of Below-Knee Lower Extremity Amputation: A Retrospective Cohort Study Using a Large Claims Database in the United States
The purpose of the study is to estimate the incidence of below-knee lower extremity amputation in type 2 diabetes mellitus (T2DM) participants newly exposed to sodium-glucose co-transporter 2 inhibitors (SGLT2i)/ non-SGLT2i…
- Trial name
- NCT02857764
- Volunteers
- 127,690 people
- Sponsor
- Janssen Research & Development, LLC