Clinical trials: Lower Limb
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
Lower Extremity Acute Limb Ischemia, LE ALI
A Study of Patients With Lower Extremity Acute Limb Ischemia to Remove Thrombus With the Indigo Aspiration System
The primary objective of this study is to collect safety and performance data on the Indigo Aspiration System in a patient population with lower extremity acute limb ischemia (LE ALI).
- Trial name
- STRIDE (NCT04144959)
- Testing
- Indigo Aspiration System
- Where
- 17 sites in United States, Germany and 1 more
- Volunteers
- 119 people
- Sponsor
- Penumbra Inc.
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.
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, 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.
Lower Limb Amputation Below Knee (Injury), Lower Limb Amputation Above Knee (Injury)
Feasibility Study to Evaluate a New Energy Storage and Return Prosthetic Foot
A prospective, interventional, multicenter pilot study to characterize differences in performance and patient reported outcomes between the Taleo, Proflex XC, and the new Revo prosthetic foot.
- Conditions
- Lower Limb Amputation Below Knee (Injury), Lower Limb Amputation Above Knee (Injury), Lower Limb Amputation Knee
- Trial name
- NCT04239222
- Testing
- Revo-M, Taleo, Proflex XC
- Where
- 4 sites in United States
- Volunteers
- 27 people
- Sponsor
- Otto Bock Healthcare Products GmbH
Chronic Lower Limb Pain
Basic Assessment of Safety and Minimally Invasive Stimulation Via Injectrode
The objectives of this non-significant risk (NSR) study are to evaluate the safety of the short term placement of the Basmati Injectrode for up to 28 days and the efficacy of conducting electrical current to stimulate…
- Trial name
- BASMATI (NCT04672096)
- Testing
- Neuronoff BASMATI Injectrode
- Where
- United States
- Volunteers
- 10 people, healthy volunteers welcome
- Sponsor
- Neuronoff, Inc
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.
Osteoarthritis, Rheumatoid Arthritis
Randomized Controlled Clinical Outcomes of the Vanguard XP Bicruciate Knee System
Randomized Controlled Study to determine if preservation of ligaments provides increased functional ability post-operatively in comparison to traditional TKA which sacrifices soft tissue.
- Conditions
- Osteoarthritis, Rheumatoid Arthritis, Traumatic Arthritis, Lower Limb Deformity
- Trial name
- GK9B (NCT02175576)
- Testing
- Vanguard XP Bicruciate Knee System, Vanguard CR Knee System
- Where
- 2 sites in United States
- Volunteers
- 50 people
- Sponsor
- Zimmer Biomet
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
Lower Limb Spasticity Due to Cerebral Palsy
Dose-response Study of Efficacy and Safety of Botulinum Toxin Type A to Treat Spasticity of the Leg(s) in Cerebral Palsy
The purpose of this study is to determine whether injections of Botulinum toxin type A into muscles of the leg(s) are effective in treating children/adolescents (age 2-17 years) with increased muscle tension/uncontrollable muscle…
- Trial name
- NCT01893411
- Testing
- IncobotulinumtoxinA (16 Units per kg body weight), IncobotulinumtoxinA (12 Units per kg body weight), IncobotulinumtoxinA (4 Units per kg body weight)
- Where
- 53 sites in Austria, Czechia and 12 more
- Volunteers
- 311 people
- Sponsor
- Merz Pharmaceuticals GmbH
Short Duration Lower Limb Surgery Via Spinal Anaesthesia
Spinal Anaesthesia With Chloroprocaine HCl 1% for Elective Lower Limb Procedures of Short Duration.
This study evaluate the effect of 3 doses of Chloroprocaine HCl 1% (30, 40 and 50 mg) for spinal anaesthesia in adult patients undergoing short duration elective surgery of the lower limb.
- Trial name
- NCT02481505
- Testing
- Chloroprocaine HCl 1%
- Where
- Italy
- Volunteers
- 45 people
- Sponsor
- Sintetica SA
Chronic, Intractable Pain of the Trunk and/or Lower Limbs
Evaluating Anatomic Versus Targeted Lead Placement for Burst Stimulation Therapy During the Trial
Prospective, multi-center, randomized, single blind study
- Trial name
- DELIVERY (NCT03277378)
- Testing
- lead placement followed by BurstDR stimulation
- Where
- 25 sites in United States, Australia and 5 more
- Volunteers
- 270 people
- Sponsor
- Abbott Medical Devices
Chronic Lower Limb Pain
A Safety and Effectiveness Trial of Spinal Cord Stimulation of the Dorsal Root Ganglion for Chronic Lower Limb Pain
The purpose of this study is to evaluate the safety and effectiveness of the AXIUM Neurostimulator System for the treatment of chronic lower limb pain in persons diagnosed with Complex Regional Pain Syndrome (CRPS) or Peripheral…
- Trial name
- ACCURATE (NCT01923285)
- Testing
- AXIUM Neurostimulator System, Control Spinal Cord Stimulation Device
- Where
- 22 sites in United States
- Volunteers
- 152 people
- Sponsor
- Abbott Medical Devices
Critical Lower Limb Ischemia
Study of IN.PACT Amphirion™ Drug Eluting Balloon vs. Standard PTA for the Treatment of Below the Knee Critical Limb Ischemia
This is a prospective, multi-center, randomized (2:1) trial of symptomatic patients with critical limb ischemia (CLI) secondary to atherosclerotic lesions (stenotic or occluded) of the infrapopliteal vessels.
- Trial name
- INPACT-DEEP (NCT00941733)
- Testing
- IN.PACT Amphirion, Standard PTA
- Where
- 13 sites in Austria, Belgium and 4 more
- Volunteers
- 358 people
- Sponsor
- Medtronic Endovascular
Lower Limb and Combined Lower Limb and Upper Limb Spasticity Due to Cerebral Palsy
Long-term Open-label Study of Botulinumtoxin Type A to Treat Spasticity of Leg(s) or Leg(s) and Arm in Cerebral Palsy
The purpose of this study is to determine whether injections of Botulinum toxin type A into muscles of the leg(s) or of leg(s) and one arm are safe in treating children/adolescents (age 2-17 years) long-term with increased muscle…
- Trial name
- NCT01905683
- Testing
- IncobotulinumtoxinA (16-20 Units per kg body weight)
- Where
- 43 sites in Austria, Czechia and 10 more
- Volunteers
- 370 people
- Sponsor
- Merz Pharmaceuticals GmbH
Spasticity of the Upper and Lower Limb Due to Cerebral Causes
Efficacy and Safety Dose Titration Study of Botulinum Toxin Type A to Treat Spasticity in the Leg and Arm
The purpose of this study is to determine whether injections with increasing doses (up to 800 units) of Botulinum toxin type A into muscles of the leg and/or arm are safe and effective in treating patients with spasticity on one…
- Trial name
- NCT01603459
- Testing
- IncobotulinumtoxinA
- Where
- 33 sites in United States, Canada and 6 more
- Volunteers
- 155 people
- Sponsor
- Merz Pharmaceuticals GmbH
Post-stroke Spasticity of the Lower Limb
Efficacy and Safety Study of Botulinum Toxin Type A Against Placebo to Treat Spasticity in the Leg After a Stroke
The purpose of this study is to determine whether injections of Botulinum toxin type A into muscles of the leg are effective in treating patients with increased muscle tension/uncontrollable muscle stiffness (spasticity) after a…
- Trial name
- PLUS (NCT01464307)
- Testing
- IncobotulinumtoxinA (400 Units)
- Where
- 53 sites in United States, Canada and 7 more
- Volunteers
- 290 people
- Sponsor
- Merz Pharmaceuticals GmbH
Deep Vein Thrombosis of Lower Limb, Pulmonary Embolism (PE)
Deep Vein Thrombosis (DVT) Prevention in Total Hip Arthroplasty: Continuous Enhanced Circulation Therapy (CECT) Versus Low Molecular Weight Heparin (LMWH)
Evaluation of the safety and effectiveness of ActiveCare+ CECT device +/- baby dose aspirin (81 mg QD) for lowering the potential risk for bleeding and of DVT during and after THA surgery in comparison with LMWH.
- Conditions
- Deep Vein Thrombosis of Lower Limb, Pulmonary Embolism (PE), Bleeding
- Trial name
- SAFE (NCT00358735)
- Testing
- ActiveCare CECT device, Enoxaparin
- Where
- 9 sites in United States
- Volunteers
- 411 people
- Sponsor
- Medical Compression Systems