Clinical trials: Leg Injuries
Tibial Fractures
Bone Healing Accelerant Versus Standard of Care for Open Tibia Fractures
This clinical study is being conducted to demonstrate the safety and effectiveness of the Bone Healing Accelerant (BHA) product when applied to tibia (leg bone) fractures with an external wound or skin break (also called open…
- Trial name
- NCT03826784
- Testing
- BHA
- Where
- United States
- Sponsor
- Carmell Therapeutics Corporation
Fracture; Pelvic, Insufficiency Fractures
Real World Evidence of SI-BONE's iFuse TORQ TNT Advancing Treatment of Pelvic Ring Fractures
The purpose of this study is to evaluate outcomes in patients treated with iFuse TORQ TNT for pelvic fragility fractures.
- Conditions
- Fracture; Pelvic, Insufficiency Fractures, Fragility Fracture, Sacroiliac; Fusion
- Trial name
- REBAR (NCT07530497)
- Testing
- iFuse TORQ TNT Implant System
- Where
- 2 sites in United States
- Volunteers
- 120 people
- Sponsor
- SI-BONE, Inc.
Venous Leg Ulcer
Pivotal Trial of Dermagraft(R) to Treat Venous Leg Ulcers
This study randomly assigns patients with venous leg ulcers to receive standard therapy (compression) alone or compression plus Dermagraft(R).
- Trial name
- DEVO (NCT00909870)
- Testing
- Dermagraft(R), Profore
- Where
- 70 sites in United States, Austria and 6 more
- Volunteers
- 537 people
- Sponsor
- Organogenesis
Knee Pain Chronic, Knee Injuries
Treatment of Knee Pain With Topical Diclofenac Cream 8% or Diclofenac Gel 1%
Non-steroidal anti-inflammatory medication (NSAID) therapy is a mainstay treatment for joint pain and painful musculoskeletal disorders.
- Trial name
- NCT02068859
- Testing
- Diclofenac Cream 8%, Diclofenac Gel 1%
- Where
- United States
- Volunteers
- 106 people, healthy volunteers welcome
- Sponsor
- FPR Specialty Pharmacy
Diabetic Foot Ulcer
A Prospective Trial of Non-healing Diabetic Foot Ulcers Treated With Standard Care With or Without BR-AC
This trial is a multicenter, randomized, controlled study designed to evaluate the safety and efficacy of BioREtain® Amnion Chorion (BR-AC) plus standard of care versus standard of care only in the treatment of diabetic foot…
- Trial name
- NCT06511596
- Testing
- BR-AC, Standard Care
- Where
- 11 sites in United States
- Volunteers
- 71 people
- Sponsor
- BioStem Technologies
Diabetic Foot Ulcer
Restoring Tissue and Evaluating Novel Treatments for Efficacy in Wounds
This is an IRB-approved multicenter study.This non-inferiority study aims to evaluate differential healing rates between Lavior Diabetic Wound Gel and other Hydrogels.
- Trial name
- RENEW (NCT05607979)
- Testing
- Lavior Diabetic Wound Gel, Smith & Nephew Solosite Gel Hydrogel Wound Dressing
- Where
- United States
- Volunteers
- 75 people
- Sponsor
- Lavior Pharma Inc.
Lower Extremity Diabetic Leg Wounds, Lower Extremity Venous Leg Wounds
Clinical Evaluation of the SNaP Wound Care System in Promoting Healing in Chronic Wounds
The purpose of this study is to evaluate a novel topical negative pressure (TNP) wound therapy device called the SNaP® (Smart Negative Pressure) Wound Care System for the treatment of lower extremity diabetic, venous and mixed…
- Conditions
- Lower Extremity Diabetic Leg Wounds, Lower Extremity Venous Leg Wounds, Lower Extremity Mixed Aetiology Leg Wounds
- Trial name
- NCT01417208
- Testing
- SNaP® Wound Care System
- Where
- United Kingdom
- Sponsor
- KCI USA, Inc
Ankle and Hindfoot Arthrodesis
Long-term Safety and Effectiveness of AUGMENT® Injectable Bone Graft Compared to Autologous Bone Graft
The objective of this long-term study is to evaluate the long-term effectiveness and safety of AUGMENT® Injectable Bone Graft vs. autologous bone graft.
- Trial name
- NCT03998137
- Testing
- AUGMENT® Injectable Bone Graft, Standard of Care
- Volunteers
- 94 people
- Sponsor
- BioMimetic Therapeutics
Diabetic Foot Ulcer, Venous Leg Ulcer
Assessment of Wound Closure Comparing Synthetic Hybrid-Scale Fiber Matrix With Standard of Care in Treating Diabetic Foot Ulcers (DFU) and With Living Cellular Skin Substitute in Treating Venous Leg Ulcers (VLU)
In participants with diabetic foot ulcers (DFUs), this study will assess complete wound closure by comparing synthetic hybrid-scale fiber matrix (Restrata®) with standard of care.
- Trial name
- NCT04927702
- Testing
- Synthetic Hybrid-Scale Fiber Matrix, Standard of Care, Living Cellular Skin Substitute
- Where
- 6 sites in United States
- Volunteers
- 48 people
- Sponsor
- Acera Surgical, 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.
Surgical Incision, Ulcer Foot
Study to Evaluate the PICO 14 Negative Pressure Wound Therapy System in the Management of Acute and Chronic Wounds
This is a prospective, multi-center, open label study evaluating the performance of PICO14 Negative Pressure Wound Therapy (NPWT) in the management of chronic open wounds (pressure ulcers, venous leg ulcers, diabetes related foot…
- Conditions
- Surgical Incision, Ulcer Foot, Ulcer Venous, Ulcer, Leg
- Trial name
- PICO14 (NCT05234632)
- Testing
- PICO 14 single-use Negative Pressure Wound Therapy System
- Where
- 6 sites in Germany, United Kingdom
- Volunteers
- 45 people
- Sponsor
- Smith & Nephew, Inc.
Femur Fracture, Femur Fracture Intertrochanteric
THP Hip Fracture Plating System Study
The objective of this study is to systematically document the clinical outcomes of THP Hip Fracture Plating System when used to treat intracapsular and intertrochanteric fractures.
- Conditions
- Femur Fracture, Femur Fracture Intertrochanteric, Garden Grade I Subcapital Fracture of Femoral Neck, Garden Grade II Subcapital Fracture of Femoral Neck
- Trial name
- THP (NCT03870477)
- Testing
- THP Hip Fracture Plating System with telescoping lag screws
- Where
- 3 sites in United States
- Volunteers
- 1 people
- Sponsor
- Zimmer Biomet
Acquired Brain Injury (Including Stroke)
Clinical Investigation to Validate the Safety and Performance of the ABLE Exoskeleton Device for Individuals With Acquired Brain Injury in a Clinical Setting
The primary objective of the study is to validate the safety and clinical performance of the ABLE Exoskeleton device in people with acquired brain injury during a 10-session gait training program in a clinical setting.
- Trial name
- NCT07050875
- Testing
- ABLE Exoskeleton
- Where
- 3 sites in Spain
- Volunteers
- 14 people
- Sponsor
- ABLE Human Motion S.L.
Tibial Fractures
A Post-Market Clinical Evaluation of the Treatment of Tibia Fractures With the T2 Alpha Tibia Nailing System
This investigation is a prospective, multi-center clinical investigation. It is anticipated that a total of 80 subjects will be enrolled.
- Trial name
- NCT04015167
- Testing
- T2 Alpha Tibia Nailing System
- Where
- 4 sites in United States
- Volunteers
- 103 people
- Sponsor
- Stryker Trauma and Extremities
Acute Ruptures of the Anterior Cruciate Ligament
L-C Ligament Versus Hamstring Autograft for Primary ACL Reconstruction
The purpose of this study is to compare safety and efficacy outcomes of the L-C Ligament versus Hamstring Autograft for treatment of acute rupture of the ACL.
- Trial name
- NCT02183727
- Testing
- L-C Ligament, Hamstring Autograft
- Where
- Netherlands
- Volunteers
- 60 people
- Sponsor
- Soft Tissue Regeneration, Inc.
Diabetes, Diabetic Foot
Diabetic Foot Ulcer Study Comparing Cytal Wound Matrix 1-Layer to Standard of Care
This is a two-armed randomized controlled trial (RCT) primarily aimed at determining if application of Cytal Wound Matrix 1-Layer intervention to diabetic foot ulcers shows improved wound closure rates when compared to standard…
- Conditions
- Diabetes, Diabetic Foot, Diabetes Mellitus, Type 2, Diabetes Mellitus, Type 1
- Trial name
- NCT03626623
- Testing
- Cytal Wound Matrix 1-Layer, Standard of Care (SOC)
- Where
- 3 sites in United States
- Volunteers
- 15 people
- Sponsor
- Integra LifeSciences Corporation
Femoral Fractures
Study Of Tranexamic Acid For The Reduction Of Blood Loss In Patients Undergoing Surgery For Long Bone Fracture
Tranexamic acid has been shown to reduce postoperative blood losses and transfusion requirements in a number of types of surgery.
- Trial name
- NCT00824564
- Testing
- Tranexamic Acid plus standard of care, Standard of care
- Where
- India
- Volunteers
- 82 people
- Sponsor
- Pfizer
Diabetic Foot Ulcer
A RCT to Compare the Effects of Two Wound Products on Biofilm Disruption in DFUs
This study is a prospective comparative study to determine if an Iodine Gel (Iodosorb◊) is better than standard dressing (Solosite◊ gel) in disruption of biofilm (small microorganism bacteria similar to plaque on teeth) on the…
- Trial name
- NCT02181621
- Testing
- Iodosorb, Solosite gel
- Where
- United States
- Volunteers
- 19 people
- Sponsor
- Smith & Nephew, Inc.
Diabetic Foot Ulcer
Comparative Study of Two Application Regimens of Amniotic Membrane Wound Graft In the Management of Diabetic Foot Ulcers
The purpose of this study is to determine whether a weekly application of EpiFix human amniotic membrane is more effective than a biweekly application (every two weeks) in the treatment of diabetic foot ulcers.
- Trial name
- NCT01657474
- Testing
- Weekly application of EpiFix plus standard of care, Biweekly application of EpiFix plus standard of care
- Where
- 2 sites in United States
- Volunteers
- 40 people
- Sponsor
- MiMedx Group, Inc.
Venous Leg Ulcer
PLASOMA Efficacy & Technology Health (PETH) Study
This study is designed to examine beneficial effects of PLASOMA treatment compared to the standard of care on chronic venous leg ulcers (VLU) that match the size of the plasma area of the pad.
- Trial name
- NCT04922463
- Testing
- PLASOMA
- Where
- 2 sites in Netherlands
- Volunteers
- 46 people
- Sponsor
- Plasmacure