Clinical trials: Leg Injuries and Disorders
Wounds, Wound of Skin
A Clinical Investigation to Follow the Progress of Exuding Chronic Venous Leg Ulcers Using a Non-Bordered Foam Dressing
The goal of this clinical trial to follow the progress of wounds in those with chronic venous leg ulcers while using a non-bordered foam dressing.
- Conditions
- Wounds, Wound of Skin, Wound Leg, Venous Leg Ulcer
- Trial name
- NCT05608317
- Testing
- ALLEVYN Non-Adhesive
- Where
- 3 sites in United States
- Volunteers
- 20 people
- Sponsor
- Molnlycke Health Care AB
Diabetic Foot Ulcer, Wagner Grade 1 - 2
Evaluation of ELU42 Topical Spray for the Treatment of Diabetic Foot Ulcers
ELU42 01 01 (SuperHealer42) is a Phase I/IIA open label study sponsored by Eluciderm, Inc. that evaluates the safety and preliminary effectiveness of ELU42, a topical small molecule designed to modulate Wnt signaling, for the…
- Conditions
- Diabetic Foot Ulcer, Wagner Grade 1 - 2, Chronic Wound, Open Wound
- Trial name
- NCT07396376
- Testing
- ELU42 Topical Spray
- Where
- 4 sites in United States
- Volunteers
- 15 people
- Sponsor
- Eluciderm Inc
Diabetic Foot Ulcer
Safety and Efficacy of HO/03/03 10μg in the Treatment of Plantar Neuropathic Diabetic Foot Ulcers
A prospective, double blind, randomized, placebo controlled, outpatient, parallel group comparison trial to assess the safety and efficacy of HO/03/03 10µg versus Placebo, applied topically once daily for up to 14 weeks in at…
- Trial name
- Truheal (NCT00926068)
- Testing
- HO/03/03 10µg
- Where
- 33 sites in United States, India
- Volunteers
- 196 people
- Sponsor
- HealOr
Venous Leg Ulcer
A Multicentre European Study to Evaluate Granulox® Used in the Treatment Pathway of Predominantly Chronic Venous Leg Ulcers (VLUs).
The investigation is designed as an open label, randomized, prospective, assessor blinded, multi centre investigation. 254 evaluable subjects will be randomized to either standard of care group or standard of care with Granulox…
- Trial name
- Granulox01 (NCT04181320)
- Testing
- Venous Leg Ulcer Standard of Care with Granulox
- Where
- 27 sites in Croatia, Czechia and 5 more
- Volunteers
- 128 people
- Sponsor
- Molnlycke Health Care AB
Hip Disease, Hip Fractures
Observational Study Conducted on Patients Receiving the ESOP 2 Stem to Confirm Security and Performance of the Device
This study is a post-market clinical follow-up conducted in order to collect long-term data on security and performance of the ESOP 2 stem, which is intended to be implanted in case of total hip replacement, when used in real…
- Trial name
- ESOP2 (NCT04193163)
- Testing
- Hip prosthesis - ESOP 2 cementless femoral stem
- Where
- 7 sites in France
- Volunteers
- 10 people
- Sponsor
- FH ORTHO
Hip Osteoarthritis, Avascular Necrosis
Insignia™ Hip Stem Outcomes Study
The objective of this study is to evaluate the safety and effectiveness of the Insignia™ Hip Stem for global market access and post-market clinical follow-up up to 10 years postoperative.
- Conditions
- Hip Osteoarthritis, Avascular Necrosis, Rheumatoid Arthritis, Post-traumatic Osteoarthritis
- Trial name
- NCT05144191
- Testing
- Insignia uncemented Hip Stem
- Where
- 11 sites in United States
- Volunteers
- 313 people
- Sponsor
- Stryker Orthopaedics
Diabetic Foot Ulcer
Evaluating the Efficacy NeoThelium FT in the Treatment of Diabetic Foot Ulcers
This is a randomized controlled crossover trial evaluating the efficacy of NeoThelium FT in conjunction with standard of care vs. standard of care alone in treating diabetic foot ulcers.
- Trial name
- NCT06938685
- Testing
- Standard of Care, NeoThelium FT
- Where
- 8 sites in United States
- Volunteers
- 132 people
- Sponsor
- NuScience Medical Biologics, LLC
Venous Leg Ulcer, Diabetic Foot
AQUACEL® Ag+ Extra™ vs Cutimed® Sorbact®
Study is to provide a blinded assessment of wound closure status utilizing photographs collected as per standard of care (SOC) during the AAA RCT (WC-22-435).
- Trial name
- NCT07308678
- Where
- Germany
- Volunteers
- 105 people
- Sponsor
- ConvaTec Inc.
Diabetic Foot Ulcers, Venous Ulcers
Registry Trial of the Effectiveness of Platelet Rich Plasma for Chronic Non-Healing Wounds
This study will examine differences in the process of wound-healing in patients treated with platelet rich plasma (a concentration of proteins derived from a patients own blood) applied to the wound as a gel; injected into the…
- Conditions
- Diabetic Foot Ulcers, Venous Ulcers, Pressure Ulcers
- Trial name
- CMS (NCT02071979)
- Testing
- Autologous PRP Gel, Autologous PRP Injections, Autologous PRP Gel plus PRP Injections
- Where
- 6 sites in United States
- Volunteers
- 1,500 people
- Sponsor
- Arteriocyte, 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.
Venous Leg Ulcer (VLU)
Nonhealing Venous Leg Ulcers Treated With a Standard of Care (SoC) Alone or Standard of Care and Dehydrated Human Placenta Tissue (dHPT) With Crossover
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 venous leg ulcers.
- Trial name
- EVOLVE (NCT07230340)
- Testing
- Amnion-Intermediate-Chorion, Standard of Care (SOC)
- Where
- United States
- Volunteers
- 70 people
- Sponsor
- Cellution Biologics
Diabetic Foot Ulcer
Diabetic Foot Ulcers-Comparing Transforming Powder to Standard of Care
Phase IV, randomized, prospective, multi-center, open-label, comparison of transforming powder dressing to standard of care dressing for healing diabetic foot ulcers.
- Trial name
- NCT05046158
- Testing
- Transforming Powder Dressing, Standard of care topical wound agents and dressings
- Where
- 12 sites in United States
- Volunteers
- 135 people
- Sponsor
- ULURU Inc.
Diabetic Foot, Ulcer Foot
SDRM® vs. Collagen for Diabetic Foot Ulcers
Supra SDRM® is FDA-cleared as a dressing for treating partial and full-thickness wounds. It is a dermal substitute that provides a barrier and an ECM-like structure to help accelerate wound healing.
- Conditions
- Diabetic Foot, Ulcer Foot, Wound Heal
- Trial name
- NCT05883098
- Testing
- Wound debridement, Wound closure matrix application
- Where
- United States
- Volunteers
- 30 people
- Sponsor
- Polymedics Innovations Inc.
Diabetic Foot Ulcers
Omeza Products in Combination With Standard of Care for the Treatment of Diabetic Foot Ulcers
This study is to evaluate the efficacy of OCM™ used in combination with off-loading devices for the treatment of diabetic foot ulcers.
- Trial name
- NCT05417425
- Testing
- Omeza collagen matrix, Omeza lidocaine lavage, Omeza skin protectant
- Where
- United States
- Volunteers
- 25 people, healthy volunteers welcome
- Sponsor
- Omeza, LLC
Pain, Acute, Pain, Chronic
Evaluation of the Effect of the AI500™ SINGLE-DOSE GEL Medical Device in Patients With Reduced Knee Function
Evaluation of the effect of the AI500™ SINGLE-DOSE GEL medical device in patients with reduced knee function
- Conditions
- Pain, Acute, Pain, Chronic, Knee Injuries, Knee Osteoarthritis
- Trial name
- NCT05886608
- Testing
- AI 500™ SINGLE-DOSE GEL
- Where
- Italy
- Volunteers
- 35 people
- Sponsor
- Contrad Swiss SA
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.
Osteopenic Women, Proximal Femur Fracture
Copley II: Long-term Outcome Follow-up Study of Osteoporotic Women Who Underwent a Local Osteo-Enhancement Procedure (LOEP) in the Proximal Femur
To evaluate longer-term (5-7 years) outcomes of the twelve (12) subjects treated with AGN1 Femoral LOEP in the clinical study "A Prospective Pilot Evaluation of Percutaneous Osteo-supplementation in the Proximal Femur of…
- Trial name
- NCT06799143
- Volunteers
- 12 people
- Sponsor
- AgNovos Healthcare, LLC
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
Diabetic Foot Ulcer
Clinical Evaluation of the Combined Use of Apligraf® and the SNaP® Pressure Wound Therapy System
The primary purpose of this study is to evaluate the safety and efficacy of the concurrent use of Apligraf® and the SNaP® Wound Care System for the treatment of diabetic and venous stasis lower extremity ulcers.
- Trial name
- OG/SNaP (NCT01623882)
- Sponsor
- KCI USA, Inc
Diabetes Mellitus, Foot Ulcer
REOXCARE Dressing to Improve Healing in Diabetic Foot Ulcers (DFU)
It has been shown that diabetic patients present a significant increase in markers related to oxidative stress, which increases even more in those with diabetic foot ulcers and gradually depending on the severity of the injury…
- Conditions
- Diabetes Mellitus, Foot Ulcer, Neuroischemic Foot Ulcer
- Trial name
- REOXDFU (NCT05413746)
- Testing
- Reoxcare antioxidant dressing
- Where
- 2 sites in Spain
- Volunteers
- 20 people
- Sponsor
- Histocell, S.L.