Clinical trials: Pressure Ulcers
Pressure Injuries
Evaluation of Two Heel Protection Devices to Assess Off-loading Via Pressure Mapping.
The goal of this trial is to compare heel off-loading capabilities of two products
- Trial name
- NCT07734220
- Testing
- HeelMedix Basic & EHOB Waffle
- Where
- United States
- Volunteers
- 25 people, healthy volunteers welcome
- Sponsor
- Medline Industries
Wounds, Pressure Ulcer
Kerecis Real-World Fish Skin Graft Registry
Multi-center, observational (i.e., non-interventional), open-label, real-world Registry on the Use of Kerecis Devices
- Conditions
- Wounds, Pressure Ulcer, Diabetic Foot Ulcer, Venous Leg Ulcer
- Trial name
- ISACOD (NCT06384183)
- Testing
- Kerecis Fish Skin Graft
- Where
- 6 sites in United States
- Volunteers
- 600 people
- Sponsor
- Kerecis Ltd.
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
Venous Leg Ulcer (VLU)
ConvaVAC™ Ag+ Negative Pressure Wound Therapy System in Chronic Wounds
Purpose of this study is to learn more about how safe and effective the ConvaVAC™ Ag+ wound therapy system is in treating certain types of long-lasting wounds, called chronic wounds.
- Trial name
- ConvaVAC VLU (NCT07342049)
- Testing
- ConvaVAC™ Ag+ Negative Pressure Wound Therapy System
- Where
- 7 sites in Chile, United Kingdom
- Volunteers
- 87 people
- Sponsor
- ConvaTec Inc.
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.
Diabetic Foot Ulcer (DFU), Venous Leg Ulcers (VLUs)
HEAL-4: Real-World Effectiveness of 4 Amniotic Allografts Adjunctive to Standard Care in DFU, VLU, and PU
This retrospective multi-site observational cohort study uses electronic health records (EHR) from U.S. wound care centers to evaluate the effectiveness of four amniotic membrane allografts (Acesso DL, Acesso TL, Neostim DL…
- Conditions
- Diabetic Foot Ulcer (DFU), Venous Leg Ulcers (VLUs), Pressure Ulcers, Bedsores, Decubitus Ulcer
- Trial name
- HEAL-4 (NCT07223515)
- Where
- 2 sites in United States
- Volunteers
- 2,000 people
- Sponsor
- Dynamic Medical Services dba Acesso Biologics
Abdominal Wound Dehiscence, Necrotizing Soft Tissue Infection
Myriad™ Augmented Soft Tissue Reconstruction Registry
This is an observational study designed to evaluate the safety and clinical outcomes of Myriad™ in soft tissue reconstruction procedures.
- Conditions
- Abdominal Wound Dehiscence, Necrotizing Soft Tissue Infection, Lower Extremity Wound, Pilonidal Sinus
- Trial name
- MASTRR (NCT05243966)
- Testing
- Myriad Matrix™ and Myriad Morcells™
- Where
- 15 sites in United States
- Volunteers
- 800 people
- Sponsor
- Aroa Biosurgery Limited
Pressure Ulcers Stage II, Pressure Ulcers Stage III
Safety Evaluation of the KLOX BioPhotonic System in Stage II and III Pressure Ulcers
The primary objective of these case series is to evaluate the safety and tolerability of the KLOX BioPhotonic System as adjunctive therapy to Standard Of Care (SOC) in patients with stage II or III pressure ulcers.
- Trial name
- NCT02222454
- Testing
- KLOX BioPhotonic System
- Where
- 4 sites in Canada
- Volunteers
- 3 people
- Sponsor
- KLOX Technologies Inc.
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
Incontinence-associated Dermatitis, Decubitus Ulcer
Safety and Efficacy of RashEndZ Wound Aeration Technology
The aim of this study is to determine the safety and efficacy of RashEndZ therapeutic liner technology and Dynamic Oxygen Skin Therapy in improving symptoms and expediting healing of IAD and DU in adult patients.
- Trial name
- NCT07899060
- Testing
- Dynamic Oxygen Skin Therapy (DOST), Standard Wound Care
- Where
- United States
- Volunteers
- 10 people
- Sponsor
- RashEndZ Inc.
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
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
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
PMCF Study on the Safety of Linovera® for the Treatment of Category-I Pressure Ulcers/Injuries
To assess the safety and performance of Linovera® in the treatment of Category- I pressure ulcers/injuries.
- Trial name
- TRELINOIL (NCT06183086)
- Testing
- Linovera®
- Where
- Spain
- Volunteers
- 95 people
- Sponsor
- B. Braun Medical SA
Diabetic Foot Ulcer, Pressure Injury
A Dual-center Study Evaluating Clinical Acceptance of a NPWT Wound Care System
The purpose of this study is to determine if use of the Medela Invia Motion NPWT system supports acceptable progress towards the goal of therapy when treating patients with a variety of wound types during the evaluation period.
- Conditions
- Diabetic Foot Ulcer, Pressure Injury, Pressure Ulcer, Surgical Wound
- Trial name
- NCT04593693
- Testing
- Invia Motion Endure NPWT system
- Where
- 2 sites in United States
- Volunteers
- 25 people
- Sponsor
- Medela AG
Diabetic Foot Ulcer, Venous Leg Ulcer
PLASOMA Ultimate Safety & Efficacy Study
The purpose of the PULSE study are the followingL A.To perform post market clinical follow up (PMCF) on safety and efficacy: 1. Safety: To confirm transient short-terms side effects and verify long-term/outstanding risks. 2.
- Conditions
- Diabetic Foot Ulcer, Venous Leg Ulcer, Pressure Ulcer, Burn Wound
- Trial name
- PULSE (NCT04828304)
- Testing
- PLASOMA
- Where
- 6 sites in Netherlands
- Volunteers
- 101 people
- Sponsor
- Plasmacure
Wound Infection, Wound Heal
Analytical Performance of pH, HNE and MPO Levels in Detecting Wound Infection Proof of Concept Biomarker Study
The purpose of this study is to evaluate the effectiveness of a novel combination of biomarkers, pH/HNE/MPO, in detecting wound infection using the clinical judgement at 4 weeks as a standard of reference which will include a…
- Trial name
- INDICATE (NCT04979637)
- Sponsor
- ConvaTec Inc.
Pressure Ulcer
Effectiveness of Aurix Therapy in Pressure Ulcers
The aim of this trial is to demonstrate the effectiveness of complete wound healing in a prospective, open-label, randomized trial in which pressure ulcers will be treated using Aurix and standard care and compared 1:1 to…
- Trial name
- NCT02352467
- Testing
- Aurix
- Where
- 22 sites in United States
- Volunteers
- 800 people
- Sponsor
- Nuo Therapeutics
Pressure Ulcer, Venous Ulcer
PuraPly™ Antimicrobial Wound Matrix and Wound Management
The PuraPly Antimicrobial Wound Matrix (PuraPly AM) case series is a prospective, observational study for patients who have received PuraPly AM which consists of a collagen sheet coated with polyhexamethylenbiguanide…
- Conditions
- Pressure Ulcer, Venous Ulcer, Diabetic Ulcer, Surgical Wound
- Trial name
- PuraPlyAM (NCT03070938)
- Testing
- PuraPly™ Antimicrobial Wound Matrix
- Where
- United States
- Volunteers
- 100 people
- Sponsor
- Organogenesis
Pressure Ulcers, Tissue Injury
The Analysis of Skin Temperature by Long Wave Infrared Imaging to Determine Its Effectiveness as a Predictor of Tissue Injury
Long-wave infrared imaging can be used to identify skin temperature changes associated with underlying tissue changes. We want to determine if the use of Long Wave infrared Imaging is as effective as the Braden Score in…
- Trial name
- NCT00664235
- Where
- United States
- Volunteers
- 100 people, healthy volunteers welcome
- Sponsor
- Trillennium Medical Imaging, Inc.