Clinical trials: Standard Care Control
Venus Leg Ulcers
Controlled Study, Performed to Evaluate the Safety and Efficacy of EscharEx and Its Placebo (Gel Vehicle) Compared to Non-surgical Standard of Care in Participants With Venous Leg Ulcers (VLU)
The objectives of this study are: To evaluate the safety of EscharEx and its placebo Gel Vehicle compared to non-surgical standard of care (NSSOC) To assess the efficacy of EscharEx (EX-03 5% formulation) compared to placebo…
- Trial name
- H2H (NCT06690177)
- Testing
- EscharEx (EX-03), Non-surgical standard of care (NSSOC)
- Where
- 2 sites in United States, Poland
- Volunteers
- 45 people
- Sponsor
- MediWound Ltd
Multiple Sclerosis (MS)
A Study to Assess the Safety and Efficacy of Elezanumab When Added to Standard of Care in Relapsing Forms of Multiple Sclerosis
The purpose of this study is to evaluate the safety and efficacy of elezanumab in participants with relapsing Multiple Sclerosis (RMS).
- Trial name
- NCT03737851
- Testing
- elezanumab
- Where
- 49 sites in United States, Canada
- Volunteers
- 208 people
- Sponsor
- AbbVie
Emphysema
Randomized Comparison of the RePneu Lung Volume Reduction Coil (LVRC) to Standard of Care for the Treatment of Emphysema (RESET Study)
The objective of this study is to demonstrate the safety and performance of the PneumRx, Inc. Lung Volume Reduction Coil (LVRC) in a population of patients with emphysema. The PneumRx, Inc.
- Trial name
- NCT01334307
- Testing
- Lung Volume Reduction Coil (LVRC) (PneumRx), Control
- Where
- 3 sites in United Kingdom
- Volunteers
- 47 people
- Sponsor
- Boston Scientific Corporation
Meconium Aspiration
Phase III Randomized Study of Lucinactant in Full Term Newborn Infants With Meconium Aspiration Syndrome
OBJECTIVES: Evaluate the safety and efficacy of lucinactant administered by bronchoalveolar lavage (BAL) in the treatment of meconium aspiration syndrome (MAS) in newborn infants.
- Trial name
- NCT00004500
- Testing
- Lucinactant, Standard Care
- Where
- United States
- Volunteers
- 69 people
- Sponsor
- Windtree Therapeutics
Depressive Disorder, Major
A Study of Participants With Moderate or Severe Major Depressive Disorder (MDD) Requiring Urgent Symptom Control in a Psychiatric Emergency
The purpose of the study is to describe the clinical outcomes (severity of depression, severity of suicidality \& frequency of suicidal thinking, suicide events) and quality of life (QoL) of participants with symptoms of major…
- Trial name
- POWER (NCT04829669)
- Sponsor
- Janssen-Cilag Ltd.
Stoma Colostomy
Performance Study of Newly Developed Ostomy Products
The purpose of the study is to evaluate leakage of a newly developed ostomy product compared to standard care in subjects with colostomies.
- Trial name
- NCT01513330
- Testing
- SenSura Mio, Standard Care
- Where
- Germany
- Volunteers
- 122 people
- Sponsor
- Coloplast A/S
Pressure Ulcer, Stage IV, Osteomyelitis
A Randomized Controlled Phase II Trial of STIMULAN VG vs Standard of Care (SoC) for the Treatment of Osteomyelitis Associated With Stage IV Pressure Ulcers.
The purpose of this trial is to assess the safety, tolerability and between-group effect size of STIMULAN VG (with debridement) and a course of systemic antibiotics to standard of care (debridement and systemic antibiotics only)…
- Trial name
- BLADE OPU2 (NCT06283979)
- Testing
- STIMULAN VG, Standard of Care
- Where
- 9 sites in United States
- Volunteers
- 60 people
- Sponsor
- Biocomposites Ltd
Pressure Ulcer
Trial Comparing SOC +Skin IQ MCM vs SOC for Pressure Ulcer (PU)
The study is a multi-center, prospective, randomized, controlled, clinical study evaluating the effects of microclimate management using Skin IQ™ MCM coverlet placed over commercially available pressure redistribution surfaces…
- Trial name
- NCT02363842
- Testing
- Skin IQ™ MCM Coverlet, Pressure redistribution surface
- Where
- 4 sites in United States, Canada
- Volunteers
- 160 people
- Sponsor
- Arjohuntleigh
Diabetic Foot Ulcer (DFU)
Evaluating the Efficacy of FoundationDRS Solo in Addition to Standard of Care for the Treatment of Non-healing Diabetic Foot Ulcers
The goal of this clinical trial is to learn if using FoundationDRS Solo improves healing of chronic, non-healing foot ulcers in diabetic patients.
- Trial name
- NCT07290673
- Testing
- FoundationDRS Solo, Standard of Care
- Where
- United States
- Volunteers
- 124 people
- Sponsor
- Samaritan Biologics
Peripheral Nerve Injury Upper Limb, Peripheral Nerve Injury (PNI)
This Study Will Evaluate the Effectiveness of NTX-001, a Surgical Nerve Repair Product When Used in People With Upper Extremity Nerve Lacerations.
NTX-001 is a single use surgical product intended for use in conjunction with standard suture neurorrhaphy of severed nerves in patients between 18 and 80.
- Trial name
- NCT06616025
- Testing
- NTX-001 (PEG-Fusion)
- Where
- 25 sites in United States
- Volunteers
- 98 people
- Sponsor
- Neuraptive Therapeutics Inc.
Hemorrhage
The EVARREST® Fibrin Sealant Patch Liver Study
To evaluate the safety and hemostatic effectiveness of EVARREST® Fibrin Sealant Patch (EVARREST) versus standard of care treatment (SoC) in controlling parenchymal bleeding during hepatic surgery.
- Trial name
- NCT01993888
- Testing
- EVARREST® Fibrin Sealant Patch, Standard of Care (SoC)
- Where
- 17 sites in United States, Australia and 2 more
- Volunteers
- 102 people
- Sponsor
- Ethicon, Inc.
Healing
Evaluation of Preferences of Consumers and Clinicians for the Management of Shave Biopsy Sites With a PolyMem Formulation Dressing or Current Standard of Care.
Shave biopsies are often uncomfortable during the healing process. This is a preliminary study to determine if patients and clinicians prefer using PolyMem formulating dressings on shave biopsy sites compared to the current…
- Trial name
- NCT00727870
- Testing
- Shapes by PolyMem dressing, Shapes by PolyMem Silver Dressing, Shapes by PolyMem on one site and Shapes by PolyMem Silver dressing on second site
- Where
- United States
- Volunteers
- 90 people, healthy volunteers welcome
- Sponsor
- Ferris Mfg. Corp.
Diabetes Mellitus, Type 2, Acute Coronary Syndrome
Cardiovascular Outcomes Study of Alogliptin in Patients With Type 2 Diabetes and Acute Coronary Syndrome
The purpose of this study is to evaluate the cardiovascular outcomes of alogliptin, once daily (QD), compared with placebo, in addition to standard of care, in patients with type 2 diabetes mellitus and acute coronary syndrome.
- Trial name
- EXAMINE (NCT00968708)
- Testing
- Alogliptin
- Where
- 908 sites in United States, Argentina and 48 more
- Volunteers
- 5,380 people
- Sponsor
- Takeda
Diabetic Foot Ulcer
A Phase 2a Proof of Concept Open-Label, Randomized, Controlled Study to Evaluate the Safety and Efficacy of MDI-1228-mesylate Gel Compared With Standard of Care Alone in Patients With Diabetic Foot Ulcers
The study will evaluate the treatment effect of MDI-1228-mesylate Gel compared with standard of care alone for the complete healing rate at the end of 12 weeks in participants with diabetic foot ulcers (targeted ulcer).
- Trial name
- DFU (NCT06852976)
- Testing
- 0.75% MDI-1228_mesylate gel plus Standard of Care, Standard of Care Alone
- Where
- United States
- Volunteers
- 60 people
- Sponsor
- Zhuhai Rui-Inno Pharmaceutical Technology Co., Ltd.
Tibial Fractures
Multiregion BHA in 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
- NCT04056429
- Testing
- BHA
- Sponsor
- Carmell Therapeutics Corporation
Essential Fatty Acid Deficiency (EFAD)
Pediatric Study to Evaluate Risk of Developing Essential Fatty Acid Deficiency When Receiving Clinolipid or Standard-of-Care Lipid Emulsion
This will be a descriptive study designed to evaluate the propensity for hospitalized pediatric patients treated adequately with Clinolipid or standard of care for up to 90 days to develop Essential Fatty Acid Deficiency (EFAD).
- Trial name
- NCT02476994
- Testing
- Clinolipid, Intralipid
- Where
- 4 sites in United States
- Volunteers
- 1 people
- Sponsor
- Baxter Healthcare Corporation
Non-infected Venous Leg Ulcer, Venous Leg Ulcer
Non-healing Venous Leg Ulcers Treated With Standard Care With or Without BR-AC
This study examines a patient population with a non-healing, non-infected venous leg ulcer (VLU) having adequate arterial perfusion with confirmed venous reflux.
- Conditions
- Non-infected Venous Leg Ulcer, Venous Leg Ulcer, Venous Insufficiency, Venous Stasis
- Trial name
- NCT06811909
- Testing
- BR-AC, Standard Care
- Where
- 22 sites in United States
- Volunteers
- 71 people
- Sponsor
- BioStem Technologies
Shock, Hemorrhagic, Shock, Traumatic
Phase IIa Study of MP4OX in Traumatic Hemorrhagic Shock Patients
MP4OX is a novel oxygen therapeutic agent specifically developed to perfuse and oxygenate tissue at risk for ischemia and hypoxia.
- Conditions
- Shock, Hemorrhagic, Shock, Traumatic, Acidosis, Lactic
- Trial name
- NCT01004198
- Testing
- MP4OX, Ringers Lactate solution
- Where
- 13 sites in France, Germany and 2 more
- Volunteers
- 51 people
- Sponsor
- Sangart
Acute Respiratory Distress Syndrome, Infections
Rhu-pGSN for Acute Respiratory Distress Syndrome (ARDS)
BTI-203 is a randomized, double-blind, placebo-controlled, multicenter, Phase 2 proof-of-concept (POC) study to evaluate the efficacy and safety of rhu-pGSN plus standard of care (SOC) in subjects with moderate-to-severe ARDS…
- Trial name
- NCT05947955
- Testing
- Rhu-pGSN, normal saline
- Where
- 65 sites in United States, Belgium and 11 more
- Volunteers
- 600 people
- Sponsor
- BioAegis Therapeutics Inc.
Systemic Lupus Erythematosus
The WILLOW Study With M5049 in SLE and CLE (SCLE and/or DLE) (WILLOW)
The purpose of this Proof of Concept (PoC) and Dose-finding (DF) basket study is to evaluate the efficacy and safety of orally administered Enpatoran over 24 weeks in systemic lupus erythematosus (SLE) and cutaneous lupus…
- Trial name
- NCT05162586
- Testing
- Enpatoran low dose, Enpatoran medium dose, Enpatoran high dose
- Where
- 153 sites in United States, Argentina and 20 more
- Volunteers
- 456 people
- Sponsor
- EMD Serono Research & Development Institute, Inc.