Clinical trials: Pressure Ulcer Prevention
Pressure Ulcer
Prevention of Pressure Ulcers in Patients at Medium to High Risk of Pressure Ulcers Using the R'GO SOINS Overlay Mattress
The aim of the study is to determine the clinical value of using a powered alternating pressure air overlay mattress (P-APAM) in the prevention of pressure injury (PI) in patients at medium to high risk.
- Trial name
- PRESERVE (NCT06465225)
- Testing
- Use of a powered alternating pressure air mattress
- Where
- France
- Volunteers
- 90 people
- Sponsor
- Nausicaa Medical
Pressure Injury
Prevention of Pressure Ulcers in Patients at Medium to High Risk of Developing Pressure Ulcers and Using the DOMUS 4 / AUTO Motorized Air Mattress
The aim of the study is to determine the clinical value of using a powered alternating pressure air mattress (P-APAM) in the prevention of pressure injury (PI) in patients at medium to high risk.
- Trial name
- NCT05472974
- Testing
- Use of a powered alternating pressure air mattress
- Where
- 5 sites in France
- Volunteers
- 86 people
- Sponsor
- Wellell France
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
Pressure Ulcer
Comparative Prevention-effectiveness Trial of DabirAIR Overlay System
Henry Ford Health System will evaluate the DabirAIR overlay system (DOS) for its effectiveness in preventing hospital acquired pressure ulcer (HAPU) in the peri-operative setting.
- Trial name
- NCT02565797
- Testing
- DabirAIR alternating pressure overlay
- Where
- United States
- Volunteers
- 392 people
- Sponsor
- Dabir Surfaces Inc
Plantar Ulcer, Diabetes
The CareFUL Prevention Trial
To assess the efficacy of TrueContour® Insoles versus the current standard of care insoles in recurrence of plantar MTH ulcers in men and women, 18 years of age or older at the time of consent with clinical diagnosis of Diabetes…
- Conditions
- Plantar Ulcer, Diabetes, Neuropathy Causing Loss of Protective Sensation
- Trial name
- CareFULPrevent (NCT00803608)
- Testing
- TrueContour® Insole, Current standard of care insole
- Where
- 11 sites in United States
- Volunteers
- 130 people
- Sponsor
- DIApedia, LLC
Pressure Ulcer Prevention
Prevention of Pressure Ulcers by Effleurage With RIVADOUCE VEGETABLE SKINCARE OIL in Patients at Risk of Pressure Ulcers
This is a prospective, non-interventional, multicenter, post-market clinical follow-up (PMCF) study conducted in real-life conditions to assess the clinical performance and safety of RIVADOUCE VEGETABLE SKINCARE OIL in the…
- Trial name
- NCT07045480
- Where
- France
- Volunteers
- 252 people
- Sponsor
- Laboratoires RIVADIS
Pressure Injury Prevention
Evaluation of Commercially Available Heel Pads for the Prevention of Pressure Ulcers: An Observational Study of Incidence and Usability in Adult Surgical Patients.
This study will evaluate the incidence of heel pressure ulcers in adult patients undergoing elective surgery while using the Oasis Elite Heel Pad (EL130) as part of routine pressure ulcer prevention.
- Trial name
- NCT07852897
- Testing
- Oasis Elite Heel Pad (EL130)
- Where
- Ireland
- Volunteers
- 35 people, healthy volunteers welcome
- Sponsor
- Trulife
Pressure Ulcer
PMCF Study on the Safety of Linovera Emulsion for the Prevention of Cat-1 Pressure Ulcers, Vascular and DFU
To assess the safety of Linovera® Emulsion in the prevention of Grade I Pressure ulcers, Vascular and Diabetic Foot Ulcers. To assess the performance of Linovera® Emulsion for the prevention of stage 1 Pressure Ulcers, Vascular…
- Trial name
- PRELINEM (NCT05763654)
- Testing
- Linovera emulsion
- Where
- Spain
- Volunteers
- 164 people
- Sponsor
- B. Braun Medical SA
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.
Pressure Ulcer
Prevention of Pressure Ulcers in Patients at High Risk of Developping Pressure Ulcers Using the Low-pressure Motorized Air Support Mattress With XTECH®25 Control Unit
The aim of the study is to determine the clinical value of using a a low air pressure motorised therapeutic mattress in the prevention of pressure injury (PI) in patients at medium to high risk.
- Trial name
- NCT06438042
- Testing
- Use of a powered low air pressure motorised therapeutic mattress that combines the motorised and static technologies
- Where
- France
- Volunteers
- 80 people
- Sponsor
- SYSTAM
Pressure Ulcer
A Multi-centre Evaluation of the Performance of Window Dressings on Subjects With High Risk Pressure Ulceration
This study will be conducted in approximately 26 subjects in UK to yield 20 evaluable subjects at 3 sites with approximately 5-10 subjects/site.
- Trial name
- NCT01438541
- Testing
- Window
- Where
- 3 sites in United Kingdom
- Volunteers
- 29 people
- Sponsor
- Molnlycke Health Care AB
Pressure Ulcer
Phage Therapy for the Prevention and Treatment of Pressure Ulcers.
This study will evaluate a topical bacteriophage therapy product (BACTELIDE) as an adjunct to standard therapy for the prevention and treatment of pressure ulcers colonized with S. aureus, P. aeruginosa, or K. pneumoniae species.
- Trial name
- NCT04815798
- Testing
- Bacteriophage-loaded Microcapsule Spray, Standard of Care
- Volunteers
- 69 people
- Sponsor
- Precisio Biotix Therapeutics, Inc.
Diabetes, Ulceration
Shear and Pressure Reducing Insoles for the Diabetic Foot
We evaluated the feasibility of the GlideSoft™ novel insole to reduce pressure and shear forces on the foot. No commercially available insoles are designed to reduce shear.
- Conditions
- Diabetes, Ulceration, Amputation, Foot Deformity
- Trial name
- GlideSoft (NCT00499356)
- Testing
- pressure reducing insole, GlideSoft®
- Where
- United States
- Volunteers
- 299 people
- Sponsor
- Diabetica Solutions Inc.
Pressure Ulcer, Buttock
Study of TurnCare's Q-2 System on the Sacral Pressure Ulcer Prevention in High Risk Patients
This is a non-blind randomized clinical trial to determine the efficacy of the TurnCare Q2 System for the prevention of sacral region (sacral, coccygeal, and buttocks) pressure ulcers. TurnCare Q2 System has 2 main components: 1.
- Trial name
- NCT03107143
- Testing
- Q2 System
- Volunteers
- 431 people
- Sponsor
- TurnCare Inc.
Pressure Ulcer, Pressure Injury
Usability Validation of Patient Monitoring Device for Pressure Injury Prevention and Fall Detection
This study describes a procedure to collect a subject's position, movement, physiological data and usability information using Masimo's investigational device.
- Conditions
- Pressure Ulcer, Pressure Injury, Falls Injury
- Trial name
- NCT03121144
- Testing
- Masimo Centroid System
- Where
- United States
- Volunteers
- 34 people
- Sponsor
- Masimo Corporation
Heel Pressure Ulceration Prevention Strategies
Evaluation of Heel Offloading Devices for Reducing Heel Contact Pressures in Healthy Volunteers
Prevention of heel pressure ulceration is a major clinical concern. Clinical research has shown that heel-offloading devices are effective at preventing heel ulceration when compared to no offloading or sub-optimal offloading…
- Trial name
- NCT02811965
- Testing
- Pillow Condition 1, Pillow Condition 2, Heel Foam Pillow
- Where
- United States
- Volunteers
- 21 people, healthy volunteers welcome
- Sponsor
- DeRoyal Industries, Inc.
Pressure Injury, Fall Prevention
Clinical Investigation Evaluating the Use of NETSmart Solution , Incorporated to NETSoins Software, in the Care and Support of Elderly People Living in Nursing Homes
NETSmart software is designed to help doctors, nurses and care assistants adapt the care of elderly people living in nursing homes to the following risks: pressure injuries undernutrition interactions between different drugs…
- Conditions
- Pressure Injury, Fall Prevention, Undernutrition, Drug Interaction
- Trial name
- NETSMART DM (NCT07027358)
- Testing
- NETSmart software
- Where
- France
- Volunteers
- 30 people
- Sponsor
- Teranga Software
Respiratory Failure
Prevention of Pressure Ulcers in Patients Under Non-Invasive Mechanical Ventilation
This study aims to test direct application of the Non-Invasive Mechanical Ventilation -NIVM- mask or interface as the most efficient intervention to prevent Pressure Ulcers (PU), compared with other three usual preventive…
- Trial name
- PUPPVMNI (NCT02526862)
- Testing
- Allevyn Thin®, Askina Transorbent Border®, Linovera®
- Where
- Spain
- Volunteers
- 152 people
- Sponsor
- B. Braun Medical SA