Clinical trials: Pressure Injuries
Brain Injuries, Intracranial Hypertension
Development and Evaluation of the ICP Waveform Tracing Capabilities and Safety of HS-1000 Device
Invasive intracranial pressure (ICP) monitoring, using modalities such as parenchymal pressure transducer or external ventricular drain (EVD), provides an ICP waveform that encapsulates valuable diagnostic and monitoring clinical…
- Trial name
- NCT02772471
- Testing
- HS-1000
- Where
- Norway
- Volunteers
- 40 people
- Sponsor
- HeadSense Medical
Wound Healing
Efficacy Study of a Bioelectric Dressing Used With Negative Pressure Wound Therapy to Treat Diabetic and Pressure Ulcers
The purpose of this study is to determine whether a bioelectric wound dressing, used in conjunction with Negative Pressure Wound Therapy (NPWT), is effective in the treatment of diabetic and pressure ulcers of the foot.
- Trial name
- NCT01022216
- Testing
- Procellera™ Wound Dressing with V.A.C.® Therapy, V.A.C.® Therapy
- Where
- United States
- Volunteers
- 30 people
- Sponsor
- Vomaris Innovations
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
AFT/CLP-LAL RCT Stage 3 or 4 Pressure Injuries
Patients who have at least one stage 3 or 4 PI and are admitted to a participating treating facility will be candidates for study enrollment. Patients must provide written informed consent.
- Trial name
- NCT03463434
- Testing
- Air Fluidized Therapy, Continuous Low Pressure-LAL
- Where
- 2 sites in United States
- Volunteers
- 5 people
- Sponsor
- Hill-Rom
Pressure Ulcers, Venous Ulcers
Use of Fish Skin Extracellular Matrix (ECM) to Facilitate Chronic Wound Healing
The clinical study is designed to assess the effectiveness, safety and non-immunogenicity of fish skin wound dressing extracellular matrix (ECM) in treating chronic wounds.
- Conditions
- Pressure Ulcers, Venous Ulcers, Diabetic Ulcers, Chronic Ulcer of Foot
- Trial name
- NCT01348581
- Testing
- Marigen Wound Dressing
- Where
- Iceland
- Volunteers
- 37 people
- Sponsor
- Kerecis Ltd.
Pressure Ulcer, Arterial Ulcers
Suprasorb® A + Ag in the Treatment of Wounds at Risk of Infection and Infected Wounds
The aim of this post market clinical follow up (PMCF) study is to confirm the performance of Suprasorb® A + Ag wound dressing and rope, to collect safety data regarding expected adverse events and to detect potential unexpected…
- Conditions
- Pressure Ulcer, Arterial Ulcers, Venous Leg Ulcer, Diabetic Ulcers
- Trial name
- NCT05646121
- Testing
- Suprasorb® A + Ag wound dressing and rope
- Where
- 8 sites in Poland
- Volunteers
- 99 people
- Sponsor
- Lohmann & Rauscher
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
Abdomenal Wound Trauma
Non-Comparative Study of Open Abdomen That Require the Use of Negative Pressure Wound Therapy (NPWT) for Temporary Abdominal Closure
A study in which subjects with a Grade 1 or Grade 2 open abdomen that require the use of NPWT for temporary abdominal closure. Subjects will use the NPWT system for up to 14 days, with a 21 day post study initiation follow-up…
- Trial name
- NCT03431220
- Testing
- RENASYS® TOUCH Negative Pressure Wound Therapy (NPWT) Device
- Where
- United States
- Sponsor
- Smith & Nephew, Inc.
Diabetic Foot Ulcer (DFU), Venous Leg Ulcers (VLUs)
Real-World Effectiveness of Amniotic Membrane Allografts Versus Standard Wound Care in DFU, VLU, and PU
This observational study will evaluate the real-world effectiveness of four amniotic membrane-based products (Zenith™, Orion™, SurGraft FT™, Complete ACA™) in addition to standard care, compared with standard care alone.
- Conditions
- Diabetic Foot Ulcer (DFU), Venous Leg Ulcers (VLUs), Pressure Ulcers, Bedsores, Decubitus Ulcer
- Trial name
- NCT07223281
- Where
- 4 sites in United States
- Volunteers
- 2,400 people
- Sponsor
- Legacy Medical Consultants
Wound, Wound Infection
The Use of Biochemical Analyzes to Monitor the Development of Wounds
Chronic wounds represent a growing challenge in medical care. Part 1: The aim of this part of the study was to collect wound swabs and to answer the question whether the rapid diagnostic tool using enzyme activities can display…
- Conditions
- Wound, Wound Infection, Wound Contamination, Diagnostic Techniques and Procedures
- Trial name
- NPWW (NCT04507724)
- Where
- Austria
- Volunteers
- 41 people
- Sponsor
- Qualizyme Diagnostics GmbH & Co KG
Cutaneous Ulcer, Diabetic Ulcer
Dermacyte® Liquid for Treatment of Cutaneous Ulcers and Wounds
The objective of this study is to make Dermacyte Liquid available on an expanded access basis to treat cutaneous ulcers and wounds refractory to initial treatment or that do not have adequate alternative treatments.
- Conditions
- Cutaneous Ulcer, Diabetic Ulcer, Surgical Wound Dehiscence, Burns - Multiple
- Trial name
- NCT06730022
- Testing
- MTX-001 (Dermacyte Liquid)
- Where
- United States
- Sponsor
- Merakris Therapeutics
Pressure Ulcer
AutoloGel Therapy to Usual and Customary Care in Pressure Ulcers
The aim of this trial is to demonstrate the effectiveness of complete wound healing in a prospective, open-label, case-matched cohort-controlled trial in which pressure ulcers will be treated using AutoloGel and standard care and…
- Trial name
- NCT01819142
- Testing
- AutoloGel
- Where
- United States
- Volunteers
- 2 people
- Sponsor
- Cytomedix
Pressure Ulcer, Bed Sore
Early Identification of Suspected Deep Tissue Injury (sDTI)
The purpose of this study is to further clarify existing research on the early identification and documentation of suspected deep tissue injury (sDTI).
- Trial name
- NCT02705443
- Testing
- No Intervention
- Where
- United States
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- Wound Vision
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
Diabetic Amputation Foot Wound
A Study Comparing V.A.C. Negative Pressure Wound Therapy (NPWT) to Moist Wound Therapy (MWT) in the Treatment of Diabetic Foot Amputation Wounds
The objective of this study is to thoroughly examine the role of V.A.C. NPWT in the further salvage of the diabetic foot once it has undergone partial amputation.
- Trial name
- VAC 2006-19 (NCT00837096)
- Testing
- V.A.C. Therapy, Moist wound therapy (MWT)
- Volunteers
- 19 people
- Sponsor
- KCI USA, Inc
Renal Insufficiency, Acute Kidney Injury
Renal Assist Device (RAD) for Patients With Renal Insufficiency Undergoing Cardiac Surgery
The study is a prospective, non-randomized early feasibility study intended to evaluate the safety and performance of the JuxtaFlow System (also known as the JuxtaFlow Renal Assist Device (RAD)) in participants with pre-existing…
- Trial name
- BIPASS-AKI (NCT05990660)
- Testing
- JuxtaFlow System
- Where
- 3 sites in Poland, Serbia
- Volunteers
- 10 people
- Sponsor
- 3ive Labs
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 Ulcer, Venous Leg Ulcer
DETEC® pH Point of Care Wound Diagnostic Test
The purpose of this study is to determine the relationship between wound alkalinity and the non-healing status of chronic ulcer wounds.
- Conditions
- Diabetic Foot Ulcer, Venous Leg Ulcer, Pressure Ulcer, Wound, Non-Healed
- Trial name
- NCT04614038
- Testing
- DETEC® pH
- Where
- 2 sites in United States
- Volunteers
- 450 people
- Sponsor
- Progenitec Inc.
Venous Insufficiency, Venous Leg Ulcer
PICO Venous Leg Ulcers (VLU) Reimbursement Study
This study intends to demonstrate the superiority of PICO treatment when applied up to 12 weeks, versus Standard of Care (SOC) in the treatment of hard to heal Venous Leg Ulcers (VLU) by community-based practitioners.
- Trial name
- NCT06510777
- Testing
- PICO Treatment, Standard of Care (SOC) Treatment
- Where
- 44 sites in France
- Volunteers
- 142 people
- Sponsor
- Smith & Nephew, Inc.
Brain Concussion, Brain Injuries
Indirect Intracranial Pressure Measurement in Patients With Suspected or Documented Concussion
The HS-1000 is an innovative non-invasive monitoring device that employs advanced acoustic signal analysis to calculate ICP on a continuous basis.
- Trial name
- NCT02699359
- Testing
- HS-1000 recording
- Where
- United States
- Volunteers
- 100 people, healthy volunteers welcome
- Sponsor
- HeadSense Medical