Clinical trials: Lower Extremity Injuries, open to volunteers
- Condition Lower Extremity Injuries
- Status Open to volunteers
- Funder type Industry (pharma, biotech, devices)
Diabetic Foot Ulcer, Venous Leg Ulcer
Real World Evidence with the Debritom+ TM Novel Micro Water Jet Technology At a Single Wound Center
Prospective, single-blinded, single-center, parallel group, randomized controlled trial (RCT) to assess rate and frequency of wound healing and associated financial savings, when using Medaxis debritom+ versus standard of care as…
- Conditions
- Diabetic Foot Ulcer, Venous Leg Ulcer, Surgical Wound Dehiscence, Traumatic Wounds
- Trial name
- EVIDENT (NCT04920253)
- Testing
- Study Device Debridement, SOC Debridement
- Where
- United States
- Volunteers
- 180 people
- Sponsor
- Medaxis, LLC
Tibial Fracture
Assessment of the Verus Frame in Tibial Intramedullary Nailing
This prospective, single-arm Post-Market Clinical Follow-Up (PMCF) study, utilizing a registry-based control group, will assess the Verus frame's effectiveness in achieving precise tibial rotation and alignment during…
- Trial name
- NCT07362121
- Testing
- Verus frame to stabilize tibia
- Where
- Finland
- Volunteers
- 25 people
- Sponsor
- Hemitec Finland Oy
Vascular Disease, Peripheral, Chronic Wound of the Lower Limb (Leg Ulcer or Foot Ulcer)
Correlating Multispectral Near-Infrared Imaging to Standard Vascular Diagnostics
The goal of this observational study is to learn if the measures of tissue oxygenation from the MIMOSA Pro imaging device correlate to standard vascular assessment tools in patients who receiving a lower extremity vascular…
- Trial name
- NCT06899113
- Where
- United States
- Volunteers
- 60 people
- Sponsor
- MIMOSA Diagnostics Inc.
Motor Disorders, Gait Disorders, Neurologic
Adherence to Long-term Exoskeleton Rehabilitation to Treat Lower Limb Weakness and / or Deficiencies in Adult Population
In 2019, approximately 2.4 billion people worldwide required rehabilitation for various health pathologies, a 63% increase since 1990.
- Conditions
- Motor Disorders, Gait Disorders, Neurologic, Neurodegenerative Diseases, Spinal Cord Injuries
- Trial name
- ALERT (NCT06538974)
- Testing
- Hands-free exoskeleton
- Where
- France
- Volunteers
- 100 people
- Sponsor
- Wandercraft
Lower Limb Amputation Above Knee (Injury)
Assessment of the Prosthetic System Impact on Mental Workload in Above-knee Lower Limb Amputees.
New generation of lower limb prosthesis provide improved functionalities. They are usually studied in the scope of biomechanics, sometimes PROMs like quality of life.
- Trial name
- INCREMENT (NCT06635655)
- Where
- France
- Volunteers
- 9 people
- Sponsor
- Proteor Group
Diabetic Foot Ulcer, Venous Leg Ulcer
Post-Marketing Surveillance of Dehydrated Human Amnion/Chorion Membrane (DHACM) in Non-Ischemic Chronic Wounds
The purpose of this survey is to observe the efficacy and safety of EPIFIX® dehydrated human amnion/chorion membrane (DHACM) for the treatment of intractable diabetic foot ulcers or venous leg ulcers.
- Trial name
- NCT06236750
- Testing
- EPIFIX
- Where
- 5 sites in Japan
- Volunteers
- 75 people
- Sponsor
- MiMedx Group, Inc.
Venous Leg Ulcers (VLUs)
Assessing Connected-Health, Pressure-Monitoring Technology for Improving Compression Therapy in Venous Leg Ulcer Treatment
This study evaluates the effectiveness of a connected-health, pressure monitoring technology (Tight Alright) to improve clinical outcomes of compression therapy in patients with venous leg ulcers (VLUs).
- Trial name
- ACHIEVE (NCT07152717)
- Testing
- A connected-health, pressure-sensing system for monitoring sub-bandage pressure during compression therapy
- Where
- United States
- Volunteers
- 40 people
- Sponsor
- Feeltect Limited
Venous Ulcer
Monitoring of Venous Ulcers Using a Bioimpedance Measurement Based Method and System
The purpose of this study is to investigate the functionality of a new type of wound monitoring method and measurement system for monitoring healing of venous ulcers.
- Trial name
- WoundWatch® (NCT05805137)
- Testing
- WoundWatch® wound monitoring system
- Where
- 2 sites in Finland, Poland
- Volunteers
- 20 people
- Sponsor
- CutoSense Oy
Venous Leg Ulcer (VLU)
ConvaVAC™ Ag+ Negative Pressure Wound Therapy System in Chronic Wounds
Purpose of this study is to learn more about how safe and effective the ConvaVAC™ Ag+ wound therapy system is in treating certain types of long-lasting wounds, called chronic wounds.
- Trial name
- ConvaVAC VLU (NCT07342049)
- Testing
- ConvaVAC™ Ag+ Negative Pressure Wound Therapy System
- Where
- 7 sites in Chile, United Kingdom
- Volunteers
- 87 people
- Sponsor
- ConvaTec Inc.
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.
Diabetic Foot Ulcer (DFU), Ulcer
Evaluating Autologous Platelet-Rich Fibrin Plasma for Chronic Diabetic Foot Ulcers
To prospectively evaluate the safety and efficacy of an Autologous Platelet-Rich Fibrin Plasma system when applied in conjunction with Standard of Care for management of chronic Diabetic Foot Ulcers.
- Conditions
- Diabetic Foot Ulcer (DFU), Ulcer, Wound Closure, Wound Management
- Trial name
- NCT07840378
- Testing
- PRFM, Standard of Care (SoC)
- Volunteers
- 55 people
- Sponsor
- Tiger Biosciences, LLC.
Femoral Fracture
Study of the Effectiveness of a Polymer Cerclage System Compared to Cerclages Used in Standard Care (CERCPMCF) )
The use of cerclage wiring in the management of long bone fractures is common. With the increase in the placement of total hip ans shoulder prostheses, the occurrence of peri-prosthetic hip an shoulder fractures is also…
- Trial name
- SERRE (NCT05087667)
- Testing
- Implantation of Ortholoop cerclage, Implantation of Cerclage used in current practice
- Where
- 15 sites in France
- Volunteers
- 202 people
- Sponsor
- Quanta Medical
Leg Ulcer, Pressure Ulcer (PU)
Performance and Safety of Mepilex® Up in Leg and Foot Ulcers and Skin Tears
This post-market clinical follow-up investigation is designed to evaluate the performance and safety of Mepilex® Up when used for the management of exuding ulcers and skin tears on the leg and foot.
- Conditions
- Leg Ulcer, Pressure Ulcer (PU), Skin Tears, Foot Ulcer
- Trial name
- NCT07782008
- Testing
- Mepilex® Up
- Where
- Sweden
- Volunteers
- 70 people
- Sponsor
- Molnlycke Health Care AB
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
Spinal Cord Injuries, Gait Disorders, Neurologic
Safety and Feasibility of TWIICE Rise - Phase 2
The aim of this study is to assess the safety and the feasibility of two versions of TWIICE Rise for exoskeleton-assisted ambulation in patients with a spinal cord injury.
- Trial name
- NCT07461259
- Testing
- TWIICE Rise
- Where
- Switzerland
- Volunteers
- 15 people
- Sponsor
- TWIICE
Abdominal Wound Dehiscence, Necrotizing Soft Tissue Infection
Myriad™ Augmented Soft Tissue Reconstruction Registry
This is an observational study designed to evaluate the safety and clinical outcomes of Myriad™ in soft tissue reconstruction procedures.
- Conditions
- Abdominal Wound Dehiscence, Necrotizing Soft Tissue Infection, Lower Extremity Wound, Pilonidal Sinus
- Trial name
- MASTRR (NCT05243966)
- Testing
- Myriad Matrix™ and Myriad Morcells™
- Where
- 15 sites in United States
- Volunteers
- 800 people
- Sponsor
- Aroa Biosurgery Limited
Venous Leg Ulcer (VLU)
A Double Blind Study Performed to Evaluate the Efficacy and the Safety of EscharEx in Debridement of VLU (VALUE)
The main objective of this study is: To assess the efficacy and safety of EscharEx (EX-03 5% formulation) compared to placebo control,in debridement and wound bed preparation of Venous Leg Ulcers (VLU).
- Trial name
- VALUE (NCT06568627)
- Testing
- EscharEx (EX-03)
- Where
- 60 sites in United States, Austria and 7 more
- Volunteers
- 216 people
- Sponsor
- MediWound Ltd
Chronic Ulcers
Efficacy and Safety of ZKARE® Gel and Its Accessory ZKAPI® in the Treatment of Chronic Ulcers.
This prospective, randomized, single-blind, controlled clinical investigation evaluates the efficacy and safety of ZKARE®, a topical polymeric gel dressing, and its accessory applicator ZKAPI®, for the treatment of chronic…
- Trial name
- NCT07406152
- Testing
- ZKARE®, Standard Wound Care
- Where
- Spain
- Volunteers
- 134 people
- Sponsor
- i+Med S.Coop.
Venous Leg Ulcer (VLU)
EVALUATION OF THE EFFICACY AND TOLERANCE OF VASHE SOLUTION VERSUS SALINE SOLUTION IN THE TREATMENT OF VENOUS OR MIXED LEG ULCERS PRESENTING INFLAMMATORY SIGNS SUGGESTING HEAVY BACTERIAL LOAD
Evaluation of the efficacy (reduction of inflammatory signs suggesting a local infection) and tolerance (emergence and nature of adverse event) of Vashe solution vs Saline solution in the treatment of venous or mixed leg ulcers…
- Trial name
- NCT07440797
- Testing
- Saline solution, Vashe solution
- Where
- United States
- Volunteers
- 102 people
- Sponsor
- Laboratoires URGO
Chronic Wounds, Venous Leg Ulcer (VLU)
Evaluation of Cold Plasma in Chronic Wound Healing
The goal of this clinical trial is to evaluate the effectiveness of cold atmospheric plasma treatment in promoting the healing of chronic wounds in adult participants suffering from chronic wounds.
- Conditions
- Chronic Wounds, Venous Leg Ulcer (VLU), Diabetic Foot Ulcer (DFU), Pressure Ulcer (PU)
- Trial name
- PLASANAGENESIS (NCT06964048)
- Testing
- Cold Atmospheric Plasma treatment
- Volunteers
- 66 people
- Sponsor
- Plasana Medical