Clinical trials: Pressure Ulcers
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 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
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
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
Diabetes, Foot Ulcers
Evaluation of Negative Pressure Wound Therapy in the Treatment of DFUs Incl. Post Amputation Wounds.
Primary objective To assess wound healing and granulation tissue formation when using the NPWT system Secondary objectives To investigate the pain level at dressing removal To visually check exudate removal To investigate the…
- Trial name
- NCT01011387
- Testing
- NPWT System
- Where
- 2 sites in United Kingdom
- Volunteers
- 16 people
- Sponsor
- Molnlycke Health Care AB
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
Diabetic Foot Ulcers
Evaluating the Ease of Use of a VAC GranuFoam Bridge Dressing on Diabetic Foot Ulcers Receiving VAC Negative Pressure Wound Therapy
The study is aimed at evaluating the clinician's perceived ease of using the V.A.C. GranuForm bride dressing and the patients perceived level of comfort during the dressing wear.
- Trial name
- NCT00847730
- Testing
- V.A.C. Negative Pressure Wound Therapy System
- Where
- 6 sites in United States
- Volunteers
- 33 people
- Sponsor
- KCI USA, Inc
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
Wound
Evaluation of the Safety and Effectiveness of ALLEVYN Gentle Border
The clinical study will evaluate the safety and effectiveness of the ALLEVYN Gentle Border. The study is a post-market clinical follow-up to assess clinical performance and safety of ALLEVYN Gentle Border with new wound contact…
- Trial name
- NCT03877484
- Testing
- ALLEVYN Gentle border
- Where
- 6 sites in France, Germany and 1 more
- Volunteers
- 43 people
- Sponsor
- Smith & Nephew Orthopaedics AG
Pressure Ulcers
Post Market Clinical Follow-up Investigation to Evaluate Performance and Safety on Pressure Ulcers, PU, When Using Exufiber as Intended
The primary objective of this post market clinical follow-up (PMCF) investigation is to evaluate performance and safety of Exufiber when used as intended in Stage II-IV pressure ulcers (PU).
- Trial name
- NCT02224404
- Testing
- Fast Gelling Dressing (Exufiber)
- Where
- 4 sites in Belgium, Finland
- Volunteers
- 21 people
- Sponsor
- Molnlycke Health Care AB
Diabetic Foot Ulcers, Pressure Ulcers
Evaluation of the Effects of HP828-101 Versus Standard of Care in the Management of Partial or Full Thickness Wounds
To compare HP828-101 to standard of care for the management of partial or full thickness wounds
- Trial name
- NCT00971048
- Testing
- HP828-101, Hydrogel/Hydrocolloid
- Where
- 11 sites in United States
- Volunteers
- 88 people
- Sponsor
- Healthpoint
Venous Leg Ulcers, Diabetic Foot Ulcers
Single-Use Negative Pressure Wound Therapy System vs. Traditional Negative Pressure Wound Therapy System (tNPWT)
The aim of this study is to compare the clinical efficacy of two types of NPWT systems; the traditional negative pressure wound therapy (tNPWT) system and the single-use negative pressure wound therapy (PICO) system.
- Trial name
- NPWT (NCT02470806)
- Testing
- PICO System, tNPWT System
- Where
- 17 sites in United States, Canada
- Volunteers
- 164 people
- Sponsor
- Smith & Nephew, Inc.
Pressure Ulcers
Study of Thymosin Beta 4 in Patients With Pressure Ulcers
The purpose of this study is to evaluate the safety, tolerability and effectiveness of Thymosin Beta 4 administered topically in patients with Pressure Ulcers
- Trial name
- NCT00382174
- Testing
- Thymosin Beta 4
- Where
- 12 sites in United States
- Volunteers
- 72 people
- Sponsor
- RegeneRx Biopharmaceuticals, Inc.
Pressure Ulcers, Spinal Cord Injury
Comparison of HP011-101 to Standard Care for Stage I-II Pressure Ulcers in Subjects With Spinal Cord Injury
The trial will compare the effects of 14 days treatment with HP011 101 versus Standard Care in subjects with Stage I or II pressure ulcers as a complication of spinal cord injury, measured as change from baseline in composite…
- Trial name
- NCT01433159
- Testing
- HP011-101 (Xenaderm Ointment), Standard Care
- Where
- 5 sites in United States
- Volunteers
- 19 people
- Sponsor
- Healthpoint
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.
Pressure Ulcers Stage III, Pressure Ulcer, Stage IV
Comparing Concomitant Use of ACell MicroMatrix® and ACell Cytal™ to Standard of Care in Stage 3 or 4 Pressure Injuries
The purpose of this study is to evaluate incidence of complete epithelialization in stage 3 \& 4 pressure ulcers using ACell products.
- Conditions
- Pressure Ulcers Stage III, Pressure Ulcer, Stage IV, Pressure Ulcer
- Trial name
- NCT03283787
- Testing
- MicroMatrix® and Cytal™ Wound Matrix 2-Layer, MicroMatrix® and Cytal™ Wound Matrix 2-Layer plus NPWT, Negative Pressure Wound Therapy
- Where
- United States
- Volunteers
- 60 people
- Sponsor
- Integra LifeSciences Corporation
Pressure Ulcers
Pilot Study of Incidence and Change in Existing Pressure Ulcers: TC500 Bed Compared With Standard Beds
This pilot study will compare the incidence of pressure ulcers and the change in existing pressure ulcers for patients who are either placed on the new TC500 bed against those placed on the standard ICU bed in the Cardiovascular…
- Trial name
- NCT00771238
- Testing
- P500 Mattress
- Where
- United States
- Volunteers
- 52 people
- Sponsor
- Hill-Rom
Ulcers, Wounds
SNaP Wound Care System Versus Traditional NPWT Device for Treatment of Chronic Wounds
The purpose of this study is to evaluate a novel negative pressure wound therapy (NPWT) device called the SNaP device compared to a traditional NPWT device for the treatment of lower extremity diabetic and venous ulcer wounds.
- Trial name
- NCT00951080
- Testing
- Traditional NPWT System, SNaP Wound Care System
- Where
- 17 sites in United States
- Volunteers
- 132 people
- Sponsor
- 3M
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
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.