Clinical trials: Pressure Injuries, open to volunteers
Health Adult Subjects, Pressure Injury Prevention
A Trial to Investigate the New Caulis Pro® Low Air Loss (LAL) System
Investigation of biomechanical and physiological functions of laying on a new mattress in healthy volunteers.
- Trial name
- NCT07213739
- Testing
- CLP and pulsation
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- Arjo AB
Esophagus Injury, Rectal Lesion
Suprasorb® CNPendo Used for Negative Pressure Therapy in the Oesophagus and Rectum to Support Defect and Wound Healing
A Post-Market Clinical Follow-up (PMCF) study designed as non-interventional, observational, prospective, multicentre study in a routine clinical care setting using a marketed medical device in line with the corresponding…
- Trial name
- Velox (NCT05476263)
- Where
- 7 sites in Germany
- Volunteers
- 110 people
- Sponsor
- Lohmann & Rauscher
Pressure Ulcer, Ulcer
Evaluating Several Cellular, Acellular, and Matrix-like Products (CAMPs) and Standard of Care Versus Matched Standard of Care Controls in the Management of Nonhealing Pressure Ulcers
The purpose of this study it to evaluate several cellular, acellular, and matrix-like products (CAMPs) and standard of care versus matched standard of care controls in the management of nonhealing pressure ulcers.
- Conditions
- Pressure Ulcer, Ulcer, Ulcer, Pressure, Pressure Injury
- Trial name
- NCT06999590
- Testing
- ACApatch™, caregraFT™, Standard of Care
- Where
- United States
- Volunteers
- 500 people
- Sponsor
- Tiger Biosciences, LLC.
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.
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
Pressure Ulcers (Hospital-acquired Pressure Injuries)
Sacrum Pressure Injury Prevention Study Using ALLEVYN◊ Complete Care in Adults at Risk of Developing Hospital-acquired Pressure Injuries in Critical Care Units
The purpose of this study is to investigate the use of ALLEVYN◊ COMPLETE CARE Sacrum dressing for the prevention of hospital-acquired pressure injuries in adults.
- Trial name
- PACCT (NCT07849387)
- Testing
- ALLEVYN◊ COMPLETE CARE Sacrum
- Where
- 3 sites in United States
- Volunteers
- 330 people
- Sponsor
- Smith & Nephew, Inc.
Wounds and Injuries, Burns
Clinical Registry Collecting Real World Evidence on Wound Care Treatments
The proposed registry Sponsor (Siddhey LLC) will collect data on various wound treatments in real life settings. Data collection will facilitate the analysis of the safety and efficacy of wound treatments.
- Conditions
- Wounds and Injuries, Burns, Mohs Surgery, Diabetic Foot Ulcer Mixed
- Trial name
- SIDDX (NCT06328010)
- Testing
- Various types of wound care treatments
- Where
- 12 sites in United States
- Volunteers
- 5,000 people
- Sponsor
- Siddhey LLC
Pressure Ulcers Stage II, Pressure Ulcers Stage III
Comparison of Transforming Powder Dressing to NPIAP Recommended Standard of Care Therapies in Stage 2, 3 and 4 Pressure Injuries
Pressure injuries, commonly known as pressure ulcers, affect over 2.5 million people in the United States. Pressure injuries are classified into four escalating stages, from intact skin to full thickness wounds with deep tissue…
- Conditions
- Pressure Ulcers Stage II, Pressure Ulcers Stage III, Pressure Ulcer, Stage IV
- Trial name
- NCT05496296
- Testing
- Altrazeal® Transforming Powder Dressing
- Where
- 14 sites in United States
- Volunteers
- 300 people, healthy volunteers welcome
- Sponsor
- ULURU Inc.
Spinal Cord Injuries, Blood Pressure Disorders
ARC-IM System to Manage Symptomatic Blood Pressure Instability Secondary to Chronic Spinal Cord Injury
Empower BP is a pivotal, interventional, multicenter, prospective, randomized, controlled double-blinded study to evaluate the safety and effectiveness of the ARC-IM System in managing symptomatic blood pressure instability in…
- Trial name
- Empower BP (NCT07147296)
- Testing
- ARC-IM System Implantation, ARC-IM Therapy (Group 1), ARC-IM Therapy (Group 2)
- Where
- 13 sites in United States, Canada
- Volunteers
- 60 people
- Sponsor
- ONWARD Medical, Inc.
Pressure Ulcer, Ulcer, Pressure
Clinical Trial Evaluating a Single Layer Amniotic Membrane and Standard of Care in the Management of Nonhealing Pressure Ulcers
A multicenter, prospective, clinical trial evaluating a single-layer amniotic membrane (XPURT) and standard of care versus matched controls in the management of nonhealing pressure ulcers.
- Conditions
- Pressure Ulcer, Ulcer, Pressure, Pressure Wound, Pressure Area
- Trial name
- NCT07126886
- Testing
- Standard of Care, XPURT + SOC
- Where
- United States
- Volunteers
- 100 people
- Sponsor
- Applied Biologics, LLC
Skin Ulcer, Pressure Ulcer (PU)
Study Title: A Multicenter, Prospective, Modified Platform Trial Evaluating Several Cellular, Acellular, and Matrix-like Products (CAMPs) and Standard of Care Versus Matched Standard of Care Controls in the Management of Nonhealing Pressure Ulcers.
A multicenter prospective modified platform trial evaluating several cellular, acellular, and matrix like products and standard of care versus matched standard of care controls in the management of nonhealing pressure ulcers.
- Conditions
- Skin Ulcer, Pressure Ulcer (PU), Pressure Ulcer of Skin, Pressure Sore
- Trial name
- RESTORE (NCT07665268)
- Testing
- Activate™ Matrix + SOC, AmnioDefend™ FT Matrix + SOC, Palisade™ DM Matrix + SOC
- Where
- United States
- Volunteers
- 2,000 people
- Sponsor
- Sequence LifeScience, Inc.
Frequency and Type of Medical Adhesive-Related Skin Injury, NPWT Drape Seal Effectiveness Rate (or Leak Incidence Rate)
Evaluation of a Switchable Acrylic Adhesive Drape for Safer Removal in Negative Pressure Wound Therapy Applications.
Negative pressure wound therapy (NPWT) is widely used for chronic and acute wounds, severe burns, and post-operative care. Despite its benefits, the strong adhesive required to maintain an airtight seal increases the risk of…
- Conditions
- Frequency and Type of Medical Adhesive-Related Skin Injury, NPWT Drape Seal Effectiveness Rate (or Leak Incidence Rate), Clinician Acceptability of New NPWT Drape, Patient Drop-out Rate From Prescribed NPWT Treatment
- Trial name
- NCT06717308
- Testing
- Comfort Release® NPWT drape
- Where
- 7 sites in United States
- Volunteers
- 300 people
- Sponsor
- Global Biomedical Technologies, LLC
Traumatic Brain Injury (TBI) Patients, Stroke Hemorrhagic
Non-invasive Intracranial Pressure Monitoring to Improve Emergency Care in Brazil's Public Health System
The goal of this observational study is to evaluate the diagnostic accuracy of non-invasive intracranial pressure (ICP) and intracranial compliance (ICC) pulse morphology and associated parameters (such as the P2/P1 ratio and…
- Conditions
- Traumatic Brain Injury (TBI) Patients, Stroke Hemorrhagic, Stroke Ischemic
- Trial name
- NCT07210333
- Testing
- non-invasive intracranial pressure monitoring
- Where
- 3 sites in Brazil
- Volunteers
- 300 people
- Sponsor
- Braincare USA Corp
Pressure Injury
Evaluating the Efficacy of NeoThelium FT in the Treatment of Pressure Injuries
This is a randomized controlled trial evaluating the efficacy of NeoThelium FT in conjunction with standard of care vs. standard of care alone in treating pressure injuries.
- Trial name
- NCT06918548
- Testing
- Standard of Care, NeoThelium FT
- Volunteers
- 148 people
- Sponsor
- NuScience Medical Biologics, LLC
Intracranial Pressure, Intracranial Pressure Changes
CoMind Early Feasibility Study
The purpose of this research, which has been determined as non-significant risk by the central IRB overseeing the study, is to obtain information to help further develop a machine (a medical device) to measure the pressure around…
- Conditions
- Intracranial Pressure, Intracranial Pressure Changes, Traumatic Brain Injury, Intracerebral Hemorrhage
- Trial name
- CoMind EFS (NCT06368648)
- Where
- 17 sites in United States
- Volunteers
- 581 people
- Sponsor
- CoMind Technologies Limited
Chronic Wounds, Venous Leg Ulcers (VLUs)
Efficacy of Carbonlife Amniotic Tissue Product in the Treatment of Chronic Wounds
Chronic wounds constitute a significant global health burden, affecting millions of individuals and contributing to increased morbidity, diminished quality of life, and rising healthcare costs.
- Conditions
- Chronic Wounds, Venous Leg Ulcers (VLUs), Diabetic Foot Ulcers (DFUs), Arterial Ulcers
- Trial name
- NCT07223892
- Testing
- Amniotic Tissue Allograft
- Volunteers
- 600 people
- Sponsor
- Bardia Anvar
Traumatic Brain Injury
Crainio Non-invasive ICP Monitor for TBI
The clinical investigation aims to advance the Crainio device, designed for non-invasive intracranial pressure (ICP) monitoring.
- Trial name
- NCT06453733
- Testing
- Crainio
- Where
- United Kingdom
- Volunteers
- 54 people
- Sponsor
- Crainio Ltda
Intraabdominal Hypertension, Abdominal Compartment Syndrome
Physiologic Signals and Signatures With the Accuryn Monitoring System - The Accuryn Registry
The Accuryn Registry Study is an open-ended, global, multi-center, retrospective and prospective, single-arm data collection study with an FDA cleared device. The target population are cardiovascular surgery patients.
- Conditions
- Intraabdominal Hypertension, Abdominal Compartment Syndrome, Acute Kidney Injury, Cardiovascular Surgery
- Trial name
- NCT04669548
- Testing
- Accuryn Monitoring System
- Where
- 9 sites in United States
- Volunteers
- 2,500 people
- Sponsor
- Potrero Medical
Lower Extremity, Chronic Ulcers
Evaluating Autologous Platelet-Rich Fibrin Plasma for Chronic Lower Extremity 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 lower extremity wounds.
- Conditions
- Lower Extremity, Chronic Ulcers, Pressure Ulcer (PU), Venous Leg Ulcer (VLU)
- Trial name
- NCT07862335
- Testing
- PRFM
- Volunteers
- 30 people
- Sponsor
- Tiger Biosciences, LLC.
Pressure Injury
Prospective Case Series Evaluating the Efficacy and Safety of NeoThelium FT for Chronic Pressure Ulcers
This is a prospective case series evaluating the efficacy and safety of NeoThelium FT Amnion Skin Graft in the Mangement of Chronic Pressure Ulcers
- Trial name
- NCT07158658
- Testing
- NeoThelium FT (HCT/P 361)
- Where
- 2 sites in United States
- Volunteers
- 10 people
- Sponsor
- NuScience Medical Biologics, LLC