Clinical trials: Extremity Trauma
Surgically Created Bone Defects or Bone Defects/Voids Resulting From Traumatic Injury
OSsIRIS Study - A Post-market Clinical Follow-up Investigation.
This is a prospective, observational, non-randomized, multicenter, international post-market clinical follow-up investigation aiming to confirm the performance and safety of the bone substitute b.Bone after implantation in…
- Trial name
- OSsIRIS (NCT06156904)
- Testing
- Bone grafting for the treatment of surgically created bone defects or bone defects/voids resulting from traumatic injury to promote healing in the pelvis, upper and lower extremities.
- Where
- 4 sites in Germany, United Kingdom
- Volunteers
- 135 people
- Sponsor
- GreenBone Ortho S.p.A.
Chronic Spinal Cord Injury
The Up-LIFT Study of Non-Invasive ARC Therapy for Spinal Cord Injury
The Up-LIFT Study is a prospective, single-arm study designed to evaluate the safety and effectiveness of non-invasive electrical spinal cord stimulation (ARC Therapy) administered by the LIFT System to treat upper extremity…
- Trial name
- Up-LIFT (NCT04697472)
- Testing
- LIFT System
- Where
- 14 sites in United States, Canada and 2 more
- Volunteers
- 65 people
- Sponsor
- ONWARD Medical, Inc.
Vascular Injury, Arterial Injury
Multicenter Study to Evaluate the Safety and Efficacy of SYMVESS™ in a Real World Setting in Patients With Extremity Arterial Injury Requiring Urgent Repair
The goal of this post-marketing observational study is to further assess the long-term safety and efficacy of Symvess in a real-world setting in adult patients with extremity arterial injury.
- Conditions
- Vascular Injury, Arterial Injury, Trauma Injury
- Trial name
- NCT07762794
- Testing
- Acellular Tissue Engineered Vessel
- Volunteers
- 125 people
- Sponsor
- Humacyte, Inc.
Bone Fracture
Enhancement of Bone Regeneration and Healing in the Extremities by the Use of Autologous BonoFill-II
The purpose of this clinical study is to evaluate the safety and the efficacy of BonoFill-II as an autologous bone-regenerating graft in the reconstruction of deficient bone in two clinical indications: 1.
- Trial name
- NCT03024008
- Testing
- BonoFill-II
- Where
- 6 sites in Israel
- Volunteers
- 40 people
- Sponsor
- BonusBio Group Ltd
Critical Limb Ischemia
Dissolved Oxygen Dressing to Improve Chronic Wound Healing After Revascularization for Critical Limb Ischemia
A Prospective, Randomized, Single-center Pilot Study of The OxyGenesys(TM) Dissolved Oxygen Dressing to Improve Chronic Wound Healing after REvascularization for Critical Limb Ischemia.
- Trial name
- NCT02046226
- Testing
- Oxygenesys(TM) Dissolved Oxygen Dressing
- Where
- United States
- Volunteers
- 7 people
- Sponsor
- Halyard Health
Tissue Repair, Soft Tissue Reconstruction
Urinary Bladder Matrix (UBM) Registry
The purpose of this registry is to collect real-world information on patients treated with Urinary Bladder Matrix (UBM) products.
- Conditions
- Tissue Repair, Soft Tissue Reconstruction, Wound Management, Pressure Ulcer (PU)
- Trial name
- NCT07805798
- Testing
- Urinary Bladder Matrix (UBM) Products
- Volunteers
- 300 people
- Sponsor
- Integra LifeSciences Corporation
Ulcers
Effect of NIRS-assisted Assessment on Chronic Lower Extremity and Other Chronic Non-healing Ulcers
Investigation of the predictive value of Near Infrared Spectroscopy in Chronic Lower Extremity and Other Chronic non-healing Ulcers
- Trial name
- NCT06702852
- Testing
- NIRS imaging in addition to SOC
- Where
- 4 sites in United States
- Volunteers
- 221 people
- Sponsor
- Kent Imaging Inc
Diabetic Ulcer
Evaluation of Topical Wound Oxygen (two2) Therapy
The purpose of this study is to evaluate the efficacy of the Topical Wound Oxygen (two2) therapy system on the healing of diabetic lower extremity ulcers.
- Trial name
- NCT00871312
- Testing
- Topical wound oxygen therapy
- Where
- 3 sites in United States, Canada
- Volunteers
- 21 people, healthy volunteers welcome
- Sponsor
- AOTI Ltd.
Cellular Injury and Post-Cryogenic Recovery, Cryogenic Cellular Stress
Evaluation of In-Vitro Cryo Therapeutic Protocols on Human Cell Samples (TWH-CRYO-001)
This laboratory-based study evaluates the effects of controlled cryogenic preservation on human cell samples using Truway Health's in-vitro cryo therapeutic methodology.
- Conditions
- Cellular Injury and Post-Cryogenic Recovery, Cryogenic Cellular Stress, Cold-Induced Cellular Injury, Thermal Injury Response
- Trial name
- CRYO-IVT (NCT07321028)
- Testing
- Standard Laboratory Cryopreservation Procedure, Enhanced Laboratory Cryopreservation Procedure, Normothermic Cell Culture Control
- Where
- United States
- Volunteers
- 50 people
- Sponsor
- Truway Health, Inc.
Acute Compartment Syndrome
The Use of Near Infrared Spectroscopy in the Diagnosis of Acute Compartment Syndrome in Injured Soldiers
The purpose of this study is to define the reliability and accuracy of Near Infrared Spectroscopy (NIRS) in the detection of intra-compartmental tissue perfusion in injured and noninjured extremities over time.
- Trial name
- NCT01123798
- Testing
- near-infrared spectroscopy
- Where
- Germany
- Volunteers
- 300 people, healthy volunteers welcome
- Sponsor
- J&M Shuler
Diabetic Foot, Lower Extremity Wound
Matrion™ Decellularized Placental Membrane in Subjects With Diabetic Foot Ulcers
In this study, a novel placental membrane product Matrion™ (LifeNet Health, Inc., Virginia Beach, VA) will be used as a treatment for subjects with diabetic foot ulcers.
- Trial name
- NCT05087758
- Testing
- Matrion, Conventional Care Wound Management
- Where
- 8 sites in United States
- Volunteers
- 108 people
- Sponsor
- LifeNet Health
Vascular Trauma, Arterial Injury
An Open-label Study to Assess the Safety and Efficacy of SYMVESS® as a Vascular Conduit in Adolescents With Extremity Arterial Injury.
The goal of this study is to assess the safety and efficacy of Symvess in sexually mature adolescents (17 years of age or younger) who require a vascular conduit to repair an extremity arterial injury when autologous vein graft…
- Conditions
- Vascular Trauma, Arterial Injury, Arterial Bleeding
- Trial name
- NCT07762313
- Testing
- Acellular Tissue Engineered Vessel (Symvess)
- Volunteers
- 10 people
- Sponsor
- Humacyte, Inc.
Upper Limb Amputation Below Elbow (Injury), Wrist Disarticulation
Evaluation of the Phantom X Implantable EMG Sensor System for Myoelectric Prosthesis Control
The CYBORG Study is a first-in-human clinical investigation evaluating the safety and performance of the Phantom X System, an implantable electromyography (EMG) sensor array designed to provide control of upper-limb prostheses.
- Conditions
- Upper Limb Amputation Below Elbow (Injury), Wrist Disarticulation, Transradial Amputation
- Trial name
- CYBORG (NCT07325708)
- Testing
- Phantom X multielectrode EMG sensor array implant for upper limb prosthesis control
- Where
- 2 sites in Australia
- Volunteers
- 10 people
- Sponsor
- Phantom Neuro Inc.
Upper Limb Amputation Below Elbow (Injury)
Assessment of Gesture Accuracy of a Prosthesis Control System
The study is evaluating the performance of prosthesis control system, referred to as Phantom X, in able bodied individuals and individuals with upper limb amputation at the forearm level.
- Trial name
- ASCENT (NCT06446037)
- Testing
- Non-invasive EMG band instrumentation
- Where
- United States
- Volunteers
- 11 people, healthy volunteers welcome
- Sponsor
- Phantom Neuro Inc.
Wound
A Case Series Evaluating a Collagen Wound Dressing to Treat Wounds
Chronic wounds are a source of significant morbidity and escalated healthcare costs. The wound care professional has a myriad of modern wound dressings to choose from, each of which has benefits and drawbacks.
- Trial name
- NCT03909503
- Testing
- Porcine-derived collagen wound dressing
- Sponsor
- Medline Industries
Spinal Cord Injury
A Clinical Study of a Fully Implanted, Wireless and Functional BCI for Upper-Limb Functional Replacement in Tetraplegia Due to Spinal Cord Injury: Efficacy and Safety
This prospective, multicenter, single-arm clinical trial will enroll subjects with tetraplegia secondary to spinal cord injury. An implantable brain-computer interface system for compensatory hand motor function will be used to…
- Trial name
- "Triple-F" BCI (NCT07720882)
- Testing
- "Triple-F" BCI
- Where
- China
- Volunteers
- 32 people
- Sponsor
- NeuroXess Technology (shanghai) Co.,Ltd.
Tibial Fractures
Safety Study of Treatment of Leg Fractures
This study evaluates the safety of the EVOS SMALL Plating system in patients who have a fracture of the tibia requiring surgery.
- Trial name
- EVOS SMALL (NCT03881241)
- Where
- 2 sites in United States
- Volunteers
- 2 people
- Sponsor
- Smith & Nephew, Inc.
Wounds
Post Marketing Trial for Evaluating the Effectiveness of ActiGraft in Treating Lower Extremity Hard To Heal Wounds
The study is a prospective, single arm, post- marketing study. The subjects enrolled to the study will receive weekly applications of ActiGraft until complete healing or until investigator's decision that patient can no longer…
- Trial name
- NCT04745806
- Testing
- ActiGraft
- Where
- Israel
- Volunteers
- 6 people
- Sponsor
- RedDress Ltd.
Post-stroke Spasticity, Spasticity Post-Traumatic Brain Injury
Dysport® Adult Lower Limb Spasticity Follow-on Study
The purpose of this research study is to assess the long term safety of Dysport® in hemiparetic subjects with lower limb spasticity due to stroke or traumatic brain injury over repeated treatment cycles.
- Trial name
- NCT01251367
- Testing
- Botulinum toxin type A
- Where
- 50 sites in United States, Australia and 9 more
- Volunteers
- 352 people
- Sponsor
- Ipsen
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