Clinical trials: Leg Injuries and Disorders
Venous Leg Ulcer (VLU), Diabetic Foot Ulcer (DFU)
Effectiveness of Silicone Superabsorbent Polymer Dressings for Chronic Wound Management
The purpose of this single arm clinical study is to find out how well two Silicone superabsorbent polymer dressings, RespoSorb Silicone (also known as Zetuvit Plus Silicone) and RespoSorb Silicone Border (also known as Zetuvit…
- Trial name
- NCT07549737
- Testing
- RespoSorb Silicone (RSSil), RespoSorb Silicone Border (RSSB)
- Where
- 8 sites in Poland
- Volunteers
- 80 people
- Sponsor
- HARTMANN GROUP
Venous Insufficiency, Venous Leg Ulcer
PICO Venous Leg Ulcers (VLU) Reimbursement Study
This study intends to demonstrate the superiority of PICO treatment when applied up to 12 weeks, versus Standard of Care (SOC) in the treatment of hard to heal Venous Leg Ulcers (VLU) by community-based practitioners.
- Trial name
- NCT06510777
- Testing
- PICO Treatment, Standard of Care (SOC) Treatment
- Where
- 44 sites in France
- Volunteers
- 142 people
- Sponsor
- Smith & Nephew, Inc.
Diabetic Foot Ulcers, Pressure Ulcers
Evaluation of the Effects of HP828-101 Versus Standard of Care in the Management of Partial or Full Thickness Wounds
To compare HP828-101 to standard of care for the management of partial or full thickness wounds
- Trial name
- NCT00971048
- Testing
- HP828-101, Hydrogel/Hydrocolloid
- Where
- 11 sites in United States
- Volunteers
- 88 people
- Sponsor
- Healthpoint
Diabetic Foot Ulcer (DFU)
A Study Comparing an Investigational Wound Gel With Standard Treatment for Mild to Moderate Diabetic Foot Ulcers
The goal of this clinical investigation is to evaluate if VES-0-D (an investigational wound gel) works to treat mild to moderate Diabetic Foot Ulcers.
- Trial name
- AIM-DFU (NCT07783087)
- Testing
- VES-0-D wound gel, Standard of Care (Investigator Choice)
- Where
- 8 sites in Belgium
- Volunteers
- 64 people
- Sponsor
- Flen Health
Hip Arthritis, Osteoarthritis, Hip
Observational Study to Collect Safety Data and PROMs on Primary THA
This observational study is designed to collect safety data and PROMs on retrospective primary total hipa arthroplasty surgeries with Trinity cup and Meije Duo cementless hip system
- Conditions
- Hip Arthritis, Osteoarthritis, Hip, Coxitis, Femoral Head Necrosis
- Trial name
- NCT06518993
- Testing
- Total hip arthroplasty with a Trinity cup and a Meije Duo cementless stem
- Where
- France
- Volunteers
- 116 people
- Sponsor
- Corin
Osteoarthritis, Hip, Fracture of Hip
Post Market Clinical Follow-Up of the Zimmer Stafit Acetabular System
This study is a Post Market Clinical Follow up study to fulfil the post market surveillance obligations according to Medical Device Directive and European Medical Device Vigilance System (MEDDEV) 2.12-2.
- Conditions
- Osteoarthritis, Hip, Fracture of Hip, Avascular Necrosis of Hip, Dislocated Hip
- Trial name
- NCT04079114
- Testing
- Patients who received the Stafit Acetabular System
- Volunteers
- 166 people
- Sponsor
- Zimmer Biomet
Osteoarthritis, Hip, Rheumatoid Arthritis
G7 Freedom Constrained Vivacit-E Liners
The main objectives of this study are to confirm the long-term safety, performance, and clinical benefits of the G7 Freedom Constrained Vivacit-E Acetabular Liners in primary and revision total hip arthroplasty.
- Conditions
- Osteoarthritis, Hip, Rheumatoid Arthritis, Non-Union Fracture, Trochanteric Fractures
- Trial name
- NCT05587244
- Testing
- Total Hip Arthroplasty with G7 Freedom Constrained Vivacit-E Liners
- Where
- 10 sites in United States
- Volunteers
- 202 people
- Sponsor
- Zimmer Biomet
Wound Healing, Diabetic Foot
Clinical Study Evaluating Wound Closure With Endoform™ and Symphony™
Study will evaluate the performance and safety of Endoform™ Natural and Endoform™ Antimicrobial in conjunction with Symphony™ in the treatment of chronic non-healing diabetic foot ulcers after 12 weeks of treatment.
- Conditions
- Wound Healing, Diabetic Foot, Chronic Foot Ulcer, Foot Ulcer
- Trial name
- NCT06035523
- Testing
- Endoform™ Antibacterial, Endoform™ Natural, Symphony™
- Where
- 4 sites in United States
- Volunteers
- 44 people
- Sponsor
- Aroa Biosurgery Limited
Diabetic Foot Ulcer
Nonhealing Diabetic Foot Ulcers Treated With Standard of Care (SOC) Alone or Standard of Care and Amnion-Intermediate-Chorion (AIC)
The purpose of this study is to determine how well our dHPT (Dehydrated Human Placental Tissue) Product and Standard of Care work when compared to Standard of Care alone in achieving complete closure of diabetic foot.
- Trial name
- ELITE (NCT07014176)
- Testing
- Amnion-Intermediate-Chorion, Standard of Care (SOC)
- Where
- 8 sites in United States
- Volunteers
- 84 people
- Sponsor
- Cellution Biologics
Foot Fusion
Augment® Bone Graft (Formerly GEM OS™1 Bone Graft) Compared to Autologous Bone Graft in Foot and Ankle Fusions
STUDY OBJECTIVES: Demonstrate equivalent clinical and radiologic outcomes to the "gold standard" (ABG) in a representative clinical model (hindfoot and ankle fusions) STUDY HYPOTHESIS: Augment® Bone Graft is an equivalent bone…
- Trial name
- NCT00583375
- Testing
- Augment® Bone Graft, Standard of Care
- Where
- 37 sites in United States, Canada
- Volunteers
- 414 people
- Sponsor
- BioMimetic Therapeutics
Diabetic Foot Ulcer
A Clinical Investigation Evaluating Wound Closure With OptiPulse™ Versus SOC in the Treatment of Non-Healing DFU's
The purpose of this clinical investigation is to assess the safety and performance of Compedica's OptiPulse™ and to collect subject outcome data on the treatment of diabetic foot ulcers (DFU's) versus the standard of care (SOC).
- Trial name
- NCT05193929
- Testing
- OptiPulse™, Standard of Care offloading device
- Where
- 19 sites in United States, Canada
- Volunteers
- 162 people
- Sponsor
- Compedica Inc
Osteoporosis
GRACE II (General Retrospective Analysis of Commercial Experience With AGN1 LOEP)
The study is designed as a retrospective, multicenter study for subjects previously treated with the AGN1 LOEP Kit in the proximal femur as part of standard hospital practice. This will be a non-randomized and non-blinded study.
- Trial name
- NCT07594639
- Testing
- AGN1 LOEP
- Where
- Belgium
- Volunteers
- 305 people
- Sponsor
- AgNovos Healthcare, LLC
Tibial Meniscus Injuries, Osteoarthritis, Knee
Autologous, Micro-fragmented Adipose Tissue for Meniscal Tears
The menisci of the knee are essential fibro-cartilaginous structures that contribute in static weight bearing, distributing compressive forces during joint movement, joint lubrication, joint stabilization, and proprioception.
- Trial name
- NCT03714659
- Testing
- Lipogems
- Volunteers
- 20 people
- Sponsor
- New Jersey Regenerative Institute, LLC
Pressure Ulcer, Venous Ulcer
PuraPly™ Antimicrobial Wound Matrix and Wound Management
The PuraPly Antimicrobial Wound Matrix (PuraPly AM) case series is a prospective, observational study for patients who have received PuraPly AM which consists of a collagen sheet coated with polyhexamethylenbiguanide…
- Conditions
- Pressure Ulcer, Venous Ulcer, Diabetic Ulcer, Surgical Wound
- Trial name
- PuraPlyAM (NCT03070938)
- Testing
- PuraPly™ Antimicrobial Wound Matrix
- Where
- United States
- Volunteers
- 100 people
- Sponsor
- Organogenesis
Venous Leg Ulcer (VLU)
Trial to Evaluate Cyclical Topical Wound Oxygen Therapy in the Treatment of Chronic Venous Leg Ulcers
The purpose of this study is to evaluate the efficacy, safety and economic benefits of Cyclical Pressure Topical Wound Oxygen (TWO2) Therapy in the treatment of venous leg ulcers.
- Trial name
- VaLUe I (NCT06754735)
- Testing
- Topical Wound Oxygen Therapy
- Where
- United States
- Volunteers
- 212 people
- Sponsor
- AOTI Ltd.
Diabetic Foot Ulcer
RESPOND Restoring Equilibrium and Wound Stimulation to Promote Healing Of Non-healing DFUs
To evaluate the safety and effectiveness of MIST Therapy in conjunction with Standard of Care (SOC) compared to Standard of Care alone in the treatment of diabetic foot ulcers (DFU).
- Trial name
- NCT01608776
- Testing
- MIST Therapy, SOC - Standard of Care
- Where
- United States
- Volunteers
- 13 people
- Sponsor
- Celleration, Inc.
Leg Injuries, Winter Sport Resorts
Evaluation of the Prevention of Thromboembolic Disease in Patients With a Lower Limb Trauma, Non Surgical, in Winter Sports Resort
The purpose of this study is to evaluate the impact of thromboembolic diseases and heparin complications in patients with a lower limb trauma supported by physicians of mountain.
- Conditions
- Leg Injuries, Winter Sport Resorts, Outpatients
- Trial name
- M2M-Thrombose (NCT01303523)
- Where
- 28 sites in France
- Volunteers
- 1,627 people
- Sponsor
- Floralis
Diabetic Foot Ulcer, Type 1 Diabetes Mellitus
Evaluate Use of Tropocells(R) Autologous Platelet-rich Fibrin (PRF) for Wagner Grade 1 and Grade 2, Mild to Mod Neuroischemic Plantar Diabetic Foot Ulcer Wound Care.
The goal of this investigational study is to evaluate the safety and clinical performance of Tropocells Autologous Platelet-rich Fibrin (PRF) for wound care for both males and females, ages 18-80 years old, with Grade 1 and 2…
- Conditions
- Diabetic Foot Ulcer, Type 1 Diabetes Mellitus, Type 2 Diabetes Mellitus (T2DM), Neuroischemic Foot Ulcer
- Trial name
- NCT06810726
- Testing
- Platelet Rich Plasma
- Where
- 2 sites in United States
- Volunteers
- 30 people
- Sponsor
- Estar Medical dba Medical Technologies, LTD
Lower Extremity Motor Dysfunction, Spinal Cord Injury
Evaluation of the Effectiveness and Safety of AI-Robotics
Evaluation of the effectiveness and safety of the lower extremity exoskeleton rehabilitation training robot
- Trial name
- ART (NCT03452059)
- Testing
- AiLegs, AiWalker and HKAFO
- Where
- China
- Volunteers
- 40 people
- Sponsor
- AI-Robotics Technology Co., Ltd
Leg Ulcer
SANGUINATE™ in Sickle Cell Disease Associated Leg Ulcer
SANGUINATE™ Sickle Cell Disease associated Leg Ulcers.
- Trial name
- LU (NCT02600390)
- Testing
- SANGUINATE
- Where
- 2 sites in Dominican Republic, Panama
- Volunteers
- 10 people
- Sponsor
- Prolong Pharmaceuticals