Clinical trials: Bedsores
Pressure Injury
Skin Change Actions by Nursing
Pressure injuries, local areas of damage to the skin and underlying soft tissue that are costly and painful, are often preventable with timely use of prevention strategies.
- Trial name
- SCAN (NCT06127524)
- Testing
- SEM Scanner
- Where
- 7 sites in United States
- Volunteers
- 4,733 people, healthy volunteers welcome
- Sponsor
- University of California, Los Angeles
Pressure Sore, Pressure Ulcer
EmoLED Medical Device Treatment of Second and Third Stage Pressure Ulcers
The present clinical study aims to verify the effectiveness and safety of the blue light photobiomodulation therapy with EmoLED medical device in supporting the reparative process of the area of the second and third stage…
- Conditions
- Pressure Sore, Pressure Ulcer, Pressure Ulcers Stage III, Pressure Ulcers Stage II
- Trial name
- RISE_UP (NCT05130814)
- Testing
- blue light photobiomodulation, cleansing, hyaluronic acid gauze plus polyurethane foam
- Where
- Italy
- Volunteers
- 48 people
- Sponsor
- Emoled
Pressure Ulcer
Efficacy and Safety of MedifoamⓇ and BetafoamⓇ in Pressure Ulcer
This study aims to exploratively assess the efficacy and safety of hydrophilic polyurethane foam dressing (MedifoamⓇ or BetafoamⓇ) in pressure ulcer specifically. The target enrolment is 20 patients, with 10 patients per arm.
- Trial name
- NCT02863263
- Testing
- Foam Dressing, Foam Dressing with Povidone Iodine
- Where
- South Korea
- Volunteers
- 5 people
- Sponsor
- Mundipharma Pte Ltd.
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 Ulcer
Fluid Immersion Simulation (FIS) System Versus Air Fluidized Bed (AFB) System for Pressure Ulcers
The primary objective is to compare the efficacy of the FIS on closure rate to the AFB after 2 weeks of operative debridement and closure.
- Trial name
- NCT03522714
- Testing
- Fluid Immersion Simulation System, Air Fluidized Bed System
- Where
- United States
- Volunteers
- 80 people
- Sponsor
- Northwestern University
Pressure Ulcer, Leg Ulcer
Evaluation Of An Advanced Borderless Dressing
This study will gather preliminary clinical, health economic, and safety data on the treatment of chronic wounds with the ALLEVYN Life Non-Bordered dressing compared to standard of care treatment when used on a wound.
- Conditions
- Pressure Ulcer, Leg Ulcer, Diabetic Foot Ulcer
- Trial name
- NCT03146845
- Testing
- ALLEVYN Life Non-Bordered, Standard Care
- Where
- 6 sites in United States
- Volunteers
- 40 people
- Sponsor
- Smith & Nephew, Inc.
Pressure Ulcer Prevention
Comparing the Effects of Three Different Dressings on the Cutaneous Response of Sacral Skin
Skin functional parameters such as erythema or stratum corneum hydration have been successfully used in PU prevention research. These parameters are able to discriminate effects of different loading intensities and to measure PU…
- Trial name
- NCT03815240
- Testing
- No dressing, Mepilex® Border Sacrum, ALLEVYN Life Sacrum
- Where
- Germany
- Volunteers
- 12 people, healthy volunteers welcome
- Sponsor
- Charite University, Berlin, Germany
Spinal Cord Injury
Developing a Home Telehealth Program to Manage Pressure Ulcers in SCI/D
The Veteran's Health Administration (VHA) is a national leader in using distance technology to monitor patients' self-care via an in-home messaging device with disease management protocols (DMPs).
- Trial name
- NCT00624806
- Testing
- Daily telephone calls, Weekly telephone calls
- Where
- 2 sites in United States
- Volunteers
- 18 people, healthy volunteers welcome
- Sponsor
- US Department of Veterans Affairs
Hypotension, Pressure Ulcer
Comparison of Nasal and Forehead Oximetry in Critically Ill Patients at Risk for Decreased Peripheral Perfusion
Continuous pulse oximetry monitoring is the standard of care in critically ill patients in emergency departments, operating rooms and intensive care units.
- Trial name
- NCT02382133
- Testing
- Nasal alar oxygen sensor
- Where
- United States
- Volunteers
- 43 people
- Sponsor
- Washington University School of Medicine
Pressure Ulcer
CMAP Refinement for Pressure Injury Prevention
For Veterans with spinal cord injury who use a wheelchair, pressure injuries related to sitting are a significant daily threat to well-being.
- Trial name
- NCT04309864
- Testing
- Use of CMAP app for education (in-hospital), Use of CMAP app (in-home)
- Where
- United States
- Volunteers
- 43 people, healthy volunteers welcome
- Sponsor
- VA Office of Research and Development
Pressure Injury
Decreasing Intraoperative Skin Damage in Prone Position Surgeries
Preventing Pressure Injuries among patients undergoing spinal or orthopedic surgery in the prone position is challenging because of position required for surgical access and limited availability of pressure reduction surfaces for…
- Trial name
- P3I (NCT04884737)
- Testing
- Mepilex Border Flex® (MBF) dressing
- Where
- United States
- Volunteers
- 107 people
- Sponsor
- University of California, Los Angeles
Ulcers, Bedsores
Utility of Interface Pressure Mapping
To determine if a device that measures and displays pressure that the patients feel when in bed can help nurses reposition the patient effectively and thereby reduce bedsores in the intensive care unit.
- Trial name
- NCT01439581
- Testing
- Mapping System, Non-Mapping System
- Where
- United States
- Volunteers
- 428 people
- Sponsor
- Henry Ford Health System
Pressure Ulcers
Nutritional Support in Pressure Ulcer Patients
Pressure ulcers are frequently associated with malnutrition. Previous studies have reported that nutritional support can improve the healing rate of pressure ulcers but no attention has been clearly given to the nutritional…
- Trial name
- OEST (NCT01107197)
- Testing
- Enriched nutrition formula, Control formula
- Where
- Italy
- Volunteers
- 200 people
- Sponsor
- Azienda Ospedaliero Universitaria Maggiore della Carita
Diabetic Foot Ulcer, Pressure Ulcer
A Prospective, Open Label, Multicenter Trial for Evaluating the Efficacy of Treating and Managing Wounds in Elderly Population in Specialized Nursing Facilities Using RD1
The study is a prospective, single arm, multicenter efficacy study, consisting of 60 subjects who will complete the study (note: if any patients are lost to follow-up or withdrawn, enrollment will increase to compensate for loss…
- Conditions
- Diabetic Foot Ulcer, Pressure Ulcer, Venous Leg Ulcer, Trauma Injury
- Trial name
- NCT04577183
- Testing
- RD1 System
- Where
- United States
- Volunteers
- 13 people
- Sponsor
- RedDress Ltd.
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.
Pressure Ulcers
Wound Management for Sacral Pressure Ulcers With Necrotic Tissue
Evaluation of a wound care debridement product and a moisturizer on sacral pressure ulcer wounds
- Trial name
- NCT02224638
- Testing
- TheraHoney HD, SkinTegrity
- Where
- 2 sites in United States
- Volunteers
- 21 people
- Sponsor
- Medline Industries
External Wounds Measured for Length by Width Using a Ruler
Measuring Wounds Found on the Outside of the Body Surface
The purpose of this study is to test wounds found on the outside of the body surface with an investigational medical imaging device that collects visual pictures and thermal digital pictures of the wound site.
- Trial name
- NCT01869439
- Testing
- "gold standard" LxW manual ruler measurement technique, WMMS ImageReview software's LxW measurement technique, WMMS ImageReview software's Visual External Wound Trace
- Where
- 2 sites in United States
- Volunteers
- 40 people
- Sponsor
- Wound Vision
Leg Ulcer, Diabetic Foot Ulcer
Proof of Concept (Design Validation) in Patient With Hard to Heal Wounds Such as Pressure Ulcer, Diabetic Foot Ulcer and Leg Ulcer, Leia
The purpose of this reseach study is to determine Mölnlycke Health Care´s Leia dressing performance properties is fulfilled and that the dressing is safe when used on wound types such as pressure ulcer, leg ulcer, and diabetic…
- Conditions
- Leg Ulcer, Diabetic Foot Ulcer, Pressure Ulcer
- Trial name
- NCT01966380
- Testing
- Leia
- Where
- Sweden
- Volunteers
- 6 people
- Sponsor
- Molnlycke Health Care AB
Pressure Ulcers
Evaluation of the SEM Scanner 200 for the Detection of Early Pressure Ulcers: A Multi-Site Longitudinal Study
This is a multi-site, longitudinal study to evaluate the use of the SEM Scanner as an adjunct to clinical judgment for detection of early pressure ulcers in patients before clinical judgment using signs of pressure ulcers from…
- Trial name
- NCT02701101
- Testing
- Use of SEM200 Scanner daily, Assessment and treatment of Pressure Ulcers using SOC
- Where
- United States
- Volunteers
- 189 people
- Sponsor
- Bruin Biometrics, LLC
Pressure Ulcer
Comparison Between a Novel Proning Pillow System and Standard Pillows
During the COVID-19 pandemic, intensive care units (ICUs) across the country have been inundated with increasing numbers of COVID patients.
- Trial name
- NCT05149989
- Testing
- Proning Pillow System
- Where
- United Kingdom
- Volunteers
- 50 people, healthy volunteers welcome
- Sponsor
- Liverpool University Hospitals NHS Foundation Trust