Clinical trials: Lower Limb
Peripheral Arterial Disease, Critical Lower Limb Ischemia
Safety and Feasibility of Surmodics SUNDANCE™ Drug Coated Balloon
To evaluate the safety and performance of the Sundance™ DCB in subjects with occlusive disease of the infrapopliteal arteries.
- Trial name
- SWING (NCT04107298)
- Testing
- SUNDANCE™ Drug Coated Balloon
- Where
- 8 sites in Australia, Austria and 3 more
- Volunteers
- 35 people
- Sponsor
- SurModics, Inc.
Lower Limb Amputation Above Knee (Injury), Congenital Amputation of Lower Limb
Assessing Outcomes With Microprocessor Knee Utilization in a K2 Population
Two-phased randomized controlled trial comparing the impact of microprocessor controlled knee prostheses (MPK) with the impact of non-microprocessor controlled knee prostheses (NPMK) in patients with a transfemoral/knee…
- Conditions
- Lower Limb Amputation Above Knee (Injury), Congenital Amputation of Lower Limb, Lower Limb Amputation Knee
- Trial name
- ASCENT K2 (NCT04784429)
- Testing
- Kenevo or C-Leg 4, Non microprocessor controlled knee (NMPK)
- Where
- 90 sites in United States
- Volunteers
- 107 people
- Sponsor
- Otto Bock Healthcare Products GmbH
Lower Limb, Pareses
C-BRACE Versus SCO in Community Ambulators
The purpose of this multicentric study is to assess the impact of C-BRACE on mobility, endurance, confidence, participation, satisfaction, psychosocial adjustment and quality of life in community ambulators using a Stance Control…
- Trial name
- NCT05332509
- Testing
- C-BRACE, SCO
- Where
- 18 sites in France, Germany
- Volunteers
- 38 people
- Sponsor
- Otto Bock France SNC
Chronic Pain, Low Back Pain
A Prospective, Multi-site, Randomized, Sham-Controlled, Double-Blind Trial With One-Way Crossover Designed to Assess the Effectiveness and Safety of the Gimer NeuroBlock SCS Trialing System for the Treatment of Chronic Back Pain and/or Lower Limb Pain
This study is a prospective, multi-site, randomized, shamcontrolled, double-blind trial with one-way crossover designed to assess the effectiveness and safety of the Gimer NeuroBlock SCS Trialing System for the treatment of…
- Conditions
- Chronic Pain, Low Back Pain, Lower Limb Pain
- Trial name
- NCT04693650
- Testing
- NeuroBlock UHF stimulation
- Where
- 4 sites in Taiwan
- Volunteers
- 22 people
- Sponsor
- GiMer Medical
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
Lymphedema of Leg, Lymphedema
A Preference Study of Two Pneumatic Compression Devices for Patients With Lower Limb Lymphedema
This study will aim to undertake a preference evaluation comparing the Aria Health Aria Free™ to a competitor's device by assessing overall satisfaction and preference of the devices individually and in comparison to one another.
- Conditions
- Lymphedema of Leg, Lymphedema, Lymphedema, Secondary, Lymphedema Primary
- Trial name
- NCT05485454
- Testing
- Aria Health Aria Free, A Traditional PCD
- Where
- United States
- Volunteers
- 20 people
- Sponsor
- ResMed
Varicose Veins of Lower Limb
ACOART RF CLOSURE:Radiofrequency for Varicose Veins of Lower Extremity in China
The purpose of the RCT trial is to determine whether endovenous radiofrequency closure catheter and endovenous radiofrequency closure generator is not inferior to ClosureFast™ and ClosureRFG™ in treating varicose veins of lower…
- Trial name
- NCT04658901
- Testing
- ERA-C70,ERA-C30 and ERA-G5, ClosureFast™ and ClosureRFG™
- Where
- China
- Volunteers
- 188 people
- Sponsor
- Acotec Scientific Co., Ltd
Lower Limb Amputation Above Knee (Injury)
Above-knee Socket Evaluation : Sub-ischial vs Ischial Containment
Socket is key to provide comfort and function to lower limb amputees. A new socket, the sub-ischial socket, will be compared to "traditional" ischial containment sockets, based on comfort self-evaluation, and locomotor capacities.
- Trial name
- P20-EMBSUBI (NCT04791163)
- Testing
- Socket evaluation
- Where
- 9 sites in France
- Volunteers
- 25 people
- Sponsor
- Proteor Group
Adult Lower Limb Spasticity
Study to Assess the Effectiveness of AboBoNT-A Injections for Adult Lower Limb Spasticity in a Real Life Cohort
The purpose of the protocol is to assess the longitudinal attainment of person-centered and function related goals of patients who receive AbobotulinumtoxinA (aboBoNT-A) injections for adult lower limb spasticity over a period of…
- Trial name
- AboLiSh (NCT04050527)
- Where
- 51 sites in United States, Australia and 7 more
- Volunteers
- 438 people
- Sponsor
- Ipsen
Injury Traumatic, Muscle Injury
Antigravity Treadmill With Alter G on the Postural Stability of Traumatic Lower Limb Injuries
This prospective randomised study aimed to test the investigators's hypothesis that anti-gravity treadmill therapy has beneficial effects on postural stability tests over a standard rehabilitation protocol in patients who have…
- Conditions
- Injury Traumatic, Muscle Injury, Bone Injuries Joints, Tendon Injuries
- Trial name
- ALTERG20 (NCT05285020)
- Testing
- Alter G, Parallel bars and Scale, Standard rehabilitation protocol
- Volunteers
- 30 people
- Sponsor
- FREMAP Mutual Insurance Company for Occupational Accidents and Diseases
Peripheral Artery Disease, Ischaemic Ulcer of Lower Leg Due to Atherosclerotic Disease
Study of AMG0001 to Improve Ulcer Healing and Perfusion in Subjects With Peripheral Ischemic Ulcers
This study will assess the safety and efficacy of intramuscular injection of AMG0001 (hepatocyte growth factor [HGF] plasmid) to improve ulcer healing and perfusion in patients with peripheral artery disease.
- Conditions
- Peripheral Artery Disease, Ischaemic Ulcer of Lower Leg Due to Atherosclerotic Disease, Chronic Limb Threatening Ischemia, Ischemic Ulcer of Foot
- Trial name
- NCT04267640
- Testing
- AMG0001
- Where
- 20 sites in United States
- Volunteers
- 60 people
- Sponsor
- AnGes USA, Inc.
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
Lower Limb Ischemia
Feasibility Study of the TGI Adipose-derived Stromal Cell (ASC)-Coated ePTFE Vascular Graft
Researchers are actively seeking a way to coat the inside of a synthetic graft so that it more closely resembles native vessels and therefore has low thrombogenicity and low incidence of stenosis.
- Trial name
- TGI-PVG-IDE (NCT01305863)
- Testing
- ASC coated ePTFE vascular graft, Propaten graft
- Where
- United States
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- Tissue Genesis
Upper and/or Lower Limb Focal Spasticity
A Study to Review Treatment Outcomes From Treatment With Dysport® Injections in Adults for Upper and/or Lower Limb Focal Spasticity
The aim of this retrospective study is to describe the real-world outcomes with the treatment of adult patients with Dysport® injections for focal upper limb spasticity (ULS) and/or focal lower limb spasticity (LLS) in NHS…
- Trial name
- DYSCOVER (NCT04604379)
- Where
- 3 sites in United Kingdom
- Volunteers
- 123 people
- Sponsor
- Ipsen
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
Lower Limb Spasticity
Effectiveness and Safety of Dysport® (abobotulinumtoxinA) in Paediatric Lower Limb Spasticity
The purpose of this study is to assess the longitudinal attainment of subject centred and functional related goals (cumulated Goal Attainment Scale Total (GAS T) score) after abobotulinumtoxinA injection (including following…
- Trial name
- NCT03017729
- Testing
- Botulinum toxin type A
- Where
- 27 sites in United States
- Volunteers
- 242 people
- Sponsor
- Ipsen
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
Spinal Cord Injuries, Paraplegia
Evaluation of Safety and Performance of the Atalante System With Patients With Lower Limb Paralysis
The study is a prospective, open, bicentric and observational study. It is conducted to assess the safety and performance of the Atalante exoskeleton system with patients with lower limb paralysis.
- Conditions
- Spinal Cord Injuries, Paraplegia, Paralysis, Lower Limbs, Lower Extremity
- Trial name
- NCT04110561
- Testing
- Use of the Atalante exoskeleton
- Where
- 2 sites in France
- Volunteers
- 12 people
- Sponsor
- Wandercraft