Clinical trials: Lower Limb
Lower Limb Ischaemia
Nasal High Flow Oxygen in Patients With Lower-Limb Ischaemia
A prospective, single arm pilot efficacy study designed to evaluate the physiological and symptomatic effects of normobaric Nasal High Flow (NHF) oxygen therapy in patients with lower limb ischaemia experiencing rest pain and/or…
- Trial name
- NCT07891208
- Testing
- Nasal high flow oxygen
- Volunteers
- 40 people
- Sponsor
- Fisher and Paykel Healthcare
Lower Limb or Combined Lower Limb and Upper Limb Spasticity Due to Stroke or Traumatic Brain Injury
Study to Compare the Efficacy and Safety of NT 201 (Botulinum Toxin) With Placebo for the Treatment of Lower Limb Spasticity Caused by Stroke or Traumatic Brain Injury
The purpose of this study is to determine whether a single treatment with administration of 400 Units NT 201 (botulinum toxin) is superior to placebo (no medicine) for the treatment of lower limb spasticity caused by stroke or…
- Trial name
- PATTERN (NCT03992404)
- Testing
- NT 201
- Where
- 71 sites in United States, Belgium and 13 more
- Volunteers
- 603 people
- Sponsor
- Merz Pharmaceuticals GmbH
Greater Trochanteric Pain Syndrome, Greater Trochanteric Pain Syndrome of Both Lower Limbs
ReneuRx™ (Nerve Selective Therapy) Utilized in Lateral Hip Pain
The goal of this clinical trial is to evaluate the safety and analgesic performance of the ReneuRx™ device in subjects with moderate to severe chronic lateral hip pain compared to subjects receiving treatment with corticosteroid…
- Conditions
- Greater Trochanteric Pain Syndrome, Greater Trochanteric Pain Syndrome of Both Lower Limbs, Lateral Hip Pain
- Trial name
- RENEU (NCT07568015)
- Testing
- Triamcinolone acetate, ReneuRx
- Where
- 11 sites in United States
- Volunteers
- 100 people
- Sponsor
- Brixton Biosciences, Inc.
Acute Lower Limb Arterial Occlusion
The ArtixASCEND Study
This study is a post-market, prospective, multicenter, single-arm study to evaluate the safety and effectiveness of the Artix Thrombectomy System in patients with acute lower extremity arterial occlusions.
- Trial name
- NCT07135895
- Testing
- Artix Thrombectomy System
- Where
- 23 sites in United States
- Volunteers
- 250 people
- Sponsor
- Inari Medical
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.
Diabetic Foot Ulcer, Chronic Ulcers of the Lower Limb
Transverse Tibial Bone Transport (TTT) in the Management of Chronic Diabetic Lower Extremity Wounds
The purpose of this study is to evaluate the safety and clinical performance of transverse tibial bone transport in patients with chronic ischemic and diabetic lower extremity ulcers.
- Trial name
- NCT07444593
- Testing
- Biodynamik XT3
- Where
- United States
- Volunteers
- 100 people
- Sponsor
- Biodynamik, Inc
Foreign-Body Reaction, Granulomatous Disease
Prospective Stage-Stratified Histopathologic Study and Proposed Disease-Evolution Model of Gluteal Permanent Synthetic Filler Complications
This prospective biospecimen cohort will collect and analyze tissue from adults undergoing clinically indicated surgery for gluteal permanent synthetic filler disease.
- Conditions
- Foreign-Body Reaction, Granulomatous Disease, Soft Tissue Necrosis Lower Limb, Gluteal Permanent Synthetic Filler Disease
- Trial name
- NCT07808970
- Testing
- Standardized Tissue Sampling During Clinically Indicated Surgery, Blinded Histopathologic Scoring
- Where
- Colombia
- Volunteers
- 200 people
- Sponsor
- Research 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 (STRIDE II)
The primary objective of this study is to collect and evaluate clinical evidence supporting the safety and performance of the Indigo™ Aspiration System in a patient population with lower extremity acute limb ischemia (LE ALI).
- Trial name
- STRIDE II (NCT06747117)
- Testing
- Indigo Aspiration System
- Where
- 45 sites in United States, Australia and 5 more
- Volunteers
- 300 people
- Sponsor
- Penumbra Inc.
Amputation, Amputation of Lower Limb
Cryo NerVe Block Extremity AmputatioN RegIStry for Post Operative and pHantom Limb Pain
The goal of this Registry is to see how the device is used when freezing nerves during an amputation procedure.
- Conditions
- Amputation, Amputation of Lower Limb, Amputation of Upper Limb, Amputation, Limb Loss
- Trial name
- VANISH (NCT06908538)
- Testing
- cryoablation
- Where
- 6 sites in United States
- Volunteers
- 2,000 people
- Sponsor
- AtriCure, Inc.
Venous Embolism of Lower Extremities (Diagnosis), Arterial Embolism and Thrombosis
Case-Specific Health Care Professional Clinical Survey of Liberant™ Thrombectomy System
The purpose of Case-Specific Health Care Professional (HCP) Clinical Survey of Liberant™ Thrombectomy System, also known as the Liberant Clinical Assessment, is to collect first-in-human clinical data to confirm the safety and…
- Conditions
- Venous Embolism of Lower Extremities (Diagnosis), Arterial Embolism and Thrombosis, Acute DVT of Lower Extremity, Chronic DVT of Lower Extremity
- Trial name
- NCT07335341
- Testing
- Liberant Thrombectomy System
- Where
- 4 sites in United States
- Volunteers
- 50 people
- Sponsor
- Medtronic Endovascular
Peripheral Arterial Disease, Critical Lower Limb Ischemia
An All-Comers Observational Study of the MicroStent™ Peripheral Vascular Stent System in Subjects With Peripheral Arterial Disease
Non-randomized, multicenter, combined prospective and retrospective cohort analysis consisting of a single arm treated with the MicroStent™ System.
- Trial name
- HEAL (NCT04110327)
- Testing
- MicroStent
- Where
- 10 sites in Austria, Belgium and 3 more
- Volunteers
- 300 people
- Sponsor
- Micro Medical Solution, Inc.
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
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
Acute Limb Ischemia, Arterial Occlusion Mesenteric Artery Superior
Post Market Surveillance to Evaluate the Efficacy and Safety of the INDIGO Aspiration System in Japan
This study aims to confirm the safety and effectiveness of the INDIGO Aspiration System in patients requiring immediate treatment for acute lower extremity artery occlusion, acute superior mesenteric artery occlusion, or severe…
- Conditions
- Acute Limb Ischemia, Arterial Occlusion Mesenteric Artery Superior, Acute DVT of Lower Extremity
- Trial name
- JapanIndigoPMS (NCT06446024)
- Testing
- Mechanical aspiration thrombectomy
- Where
- Japan
- Volunteers
- 500 people
- Sponsor
- Penumbra Inc.
Fall Prevention, Balance, Falls
Evaluating Stumble Recovery Functions of Prosthetic Knees
The study aims to conduct a formative evaluation, along with verification, validation, and comparative analysis of the stumble recovery function in prosthetic devices by collecting relevant clinical data.
- Conditions
- Fall Prevention, Balance, Falls, Amputation of Lower Limb
- Trial name
- NCT07266454
- Testing
- Prosthetic Knee (e.g Power Knee, Navii, Rheo Knee, ...)
- Where
- 2 sites in Iceland
- Volunteers
- 50 people
- Sponsor
- Össur Iceland ehf
Diabetic Foot Ulcers (DFUs), Chronic Wound of the Lower Limb (Leg Ulcer or Foot Ulcer)
Miro3D Wound Matrix Study for Diabetic Foot Ulcers and Wound Healing
This study is a prospective, randomized controlled trial designed to evaluate the effectiveness of Miro3D Wound Matrix plus Standard of Care (SOC) compared to SOC alone in treating Wagner Grade 1 diabetic foot ulcers (DFUs) and…
- Trial name
- STRIDDDE (NCT06939686)
- Testing
- Miro3D Wound Matrix, Standard of Care (SOC)
- Where
- 3 sites in United States
- Volunteers
- 30 people
- Sponsor
- Reprise Biomedical, Inc.
Lymphedema, Lymphedema of Leg
A Clinical Study to Evaluate the Effectiveness of a Novel Portable Non-Pneumatic Active Compression Device vs. an Advanced Pneumatic Compression Device for Treating Lower Extremity Lymphedema
To evaluate the Koya wearable device - a Novel Portable Non-Pneumatic Active Compression Device (NPCD) in contrast to an advanced pneumatic compression device (APCD)
- Conditions
- Lymphedema, Lymphedema of Leg, Chronic Venous Insufficiency, Venous Insufficiency
- Trial name
- TEAYS (NCT05507346)
- Testing
- Cross over Device (PCD or Dayspring - alternate to first group)
- Where
- United States
- Volunteers
- 121 people
- Sponsor
- Koya Medical, Inc.
Single Chronic Wound, Lower Limb Wound
Telemonitoring of Chronic Wound Patients Using MyDerm, a Digital Solution: Feasibility Study
The aim of this study is to assess the feasibility of integrating myDerm for remote monitoring of chronic wounds into everyday practice, for patients over 18 years of age suffering from a single chronic wound of the lower limb…
- Trial name
- PIXAPROM (NCT06704087)
- Where
- France
- Volunteers
- 25 people
- Sponsor
- Pixacare
Lower Limb Amputation Above Knee, Lower Limb Amputation Below Knee
Study on a Prosthetic Foot With Adjustable Heel Height
Most prosthetic feet have a fixed heel height, which requires users to always wear shoes with the same heel height. A fixed heel height is a significant constraint, whereas the ability to choose one's clothing freely is an…
- Trial name
- ADJUST (NCT07214493)
- Testing
- Taleo Adjust, The usual participant's foot
- Where
- 5 sites in France
- Volunteers
- 30 people
- Sponsor
- Otto Bock France SNC