Clinical trials: Pressure Injuries
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
Acute Kidney Injury, Septic Shock
Targeting Abdominal Perfusion Pressure in Septic Shock
A randomized control trial among patients with septic shock, studying the incidence, progression and recovery of AKI.
- Conditions
- Acute Kidney Injury, Septic Shock, Resuscitations
- Trial name
- MAP-APP (NCT03582046)
- Testing
- Abdominal Perfusion Pressure (APP), Mean Arterial Pressure (MAP)
- Where
- 3 sites in United States
- Volunteers
- 12 people
- Sponsor
- Potrero Medical
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
Hard to Heal Wounds
Safety and Efficacy Study of HO/03/03 10-40 Micro Grams to Treat Hard to Heal Wounds
This multicenter, prospective, open-label, outpatient study will assess the safety and efficacy of HO/03/03 10µg applied topically once daily for up to 24 weeks in up to 100 subjects with Hard to Heal documented chronic wounds of…
- Trial name
- H2H (NCT01772303)
- Testing
- HO/03/03 10-40 µg
- Where
- Israel
- Volunteers
- 100 people
- Sponsor
- HealOr
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
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
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.
Surgical Wound
Clinical Evaluation of a Novel Incisional NPWT System
A study of the first clinical use in humans of a novel NPWT system (npSIMS) to assess the suitability, safety and efficacy of the system for the management of closed surgical wounds
- Trial name
- NCT04488666
- Testing
- npSIMS
- Where
- New Zealand
- Volunteers
- 23 people
- Sponsor
- Aatru Medical LLC
Wounds
The Use of CureXcellTM in a Community Setting for the Treatment of Hard to Heal Wounds
The primary objective of the study is to define procedures for the use of CureXcellTM in the community through Clalit Health Services.
- Trial name
- NCT01113307
- Testing
- Activated allogeneic white blood cells
- Where
- 7 sites in Israel
- Volunteers
- 131 people
- Sponsor
- Macrocure Ltd.
Open Abdomen
Post Market Clinical Follow Up Study of Avance Foam Abdominal Dressing Kit in Open Abdomen
The investigation is a Post Marketing Follow-Up Study for the Avance Foam Abdominal Dressing Kit conducted as part of Mölnlycke Health Care's quality system.
- Trial name
- NCT01968811
- Testing
- Avance Foam dressing kit
- Where
- Sweden
- Volunteers
- 10 people
- Sponsor
- Molnlycke Health Care AB
Diabetic Ulcers, Venous Leg Ulcer
PMCF Study of Debridement Pad
The design of the study is a clinical trial of Debridement Pad in subjects with superficial, chronic and acute wounds consisting of Diabetic ulcers, Arterial and Venous Leg ulcers, Pressure ulcers, Postoperative wounds healing by…
- Conditions
- Diabetic Ulcers, Venous Leg Ulcer, Arterial Leg Ulcer, Pressure Ulcer
- Trial name
- NCT07255937
- Testing
- Debridement Pad
- Where
- Spain
- Volunteers
- 184 people
- Sponsor
- Advanced Medical Solutions Ltd.
Surgical Wound
Regenn® Therapy System Safety Study
The goal of this clinical trial is to evaluate the safety of the investigational device, Regenn® Negative Pressure Therapy System (Regenn® Therapy), a form of Negative Pressure Wound Therapy (NPWT), in the post-operative surgical…
- Trial name
- NCT06259409
- Testing
- Regenn® Negative Pressure Therapy System, Prevena™ Incision Management System
- Where
- United States
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Progenerative Medical, Inc
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
Brain Injuries, Intracranial Hypertension
Prospective Evaluation of the Non-invasive ICP HeadSense Monitor in TBI Patients Undergoing Invasive ICP Monitoring
Patients with severe traumatic brain injury (TBI) are admitted to the intensive care unit (ICU). Under certain condition (such as a impaired consciousness) the intracranial pressure (ICP) is measured.
- Trial name
- NCT02773862
- Testing
- HS-1000
- Where
- Netherlands
- Volunteers
- 12 people
- Sponsor
- HeadSense Medical
Wounds and Injuries, Negative Pressure Therapy
Comparison of Wound Healing Between MedCu Dressings With Copper Oxide and Negative Pressure Wound Therapy Treatment
Randomized multisite two arms study in which one arm of patients will be treated with Negative Pressure Wound Therapy (NPWT) known also as Vacuum-assisted closure (VAC) treatment ("VAC Arm") and the second arm of patients will be…
- Conditions
- Wounds and Injuries, Negative Pressure Therapy, Diabetic Foot Ulcer
- Trial name
- NCT05215730
- Testing
- MedCu wound dressings with copper oxide (COD)
- Where
- Israel
- Volunteers
- 46 people
- Sponsor
- MedCu Technologies Ltd.
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
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.
Wounds and Injuries, Burns
ACTICOAT™ for the Treatment of Burns and Chronic Wounds
The aim of the study is to evaluate participant reported quality of life, safety, and overall performance with ACTICOAT in a clinical setting.
- Conditions
- Wounds and Injuries, Burns, Pressure Ulcer, Foot Ulcer
- Trial name
- NCT02852148
- Testing
- ACTICOAT
- Where
- 3 sites in United Kingdom
- Volunteers
- 25 people
- Sponsor
- Smith & Nephew, Inc.
Diabetic Foot Ulcer
Clinical Evaluation of the Combined Use of Apligraf® and the SNaP® Pressure Wound Therapy System
The primary purpose of this study is to evaluate the safety and efficacy of the concurrent use of Apligraf® and the SNaP® Wound Care System for the treatment of diabetic and venous stasis lower extremity ulcers.
- Trial name
- OG/SNaP (NCT01623882)
- Sponsor
- KCI USA, Inc
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