Clinical trials: Ulcer, Pressure
Lower Extremity, Chronic Ulcers
Evaluating Autologous Platelet-Rich Fibrin Plasma for Chronic Lower Extremity Ulcers
To prospectively evaluate the safety and efficacy of an Autologous Platelet-Rich Fibrin Plasma system when applied in conjunction with Standard of Care for management of chronic lower extremity wounds.
- Conditions
- Lower Extremity, Chronic Ulcers, Pressure Ulcer (PU), Venous Leg Ulcer (VLU)
- Trial name
- NCT07862335
- Testing
- PRFM
- Volunteers
- 30 people
- Sponsor
- Tiger Biosciences, LLC.
Venous Leg Ulcer (VLU), Diabetic Foot Ulcer (DFU)
A Real World Data Collection of Human Amniotic Membrane(s) on Diabetic Foot Ulcers, Venous Leg Ulcers, Pressure Ulcers and Post Operative Wounds
This study is designed to evaluate the effectiveness of Tri-Membrane Wrap™, Membrane Wrap™ and Membrane Wrap-Hydro™ compared to the effectiveness of Standard of Care alone though a retrospective data collection.
- Conditions
- Venous Leg Ulcer (VLU), Diabetic Foot Ulcer (DFU), Pressure Ulcer (PU)
- Trial name
- NCT07078968
- Testing
- Tri-Membrane Wrap™, Membrane Wrap™, Membrane Wrap-Hydro™
- Where
- 4 sites in United States
- Volunteers
- 500 people
- Sponsor
- BioLab Holdings
Pressure Ulcers (Hospital-acquired Pressure Injuries)
Sacrum Pressure Injury Prevention Study Using ALLEVYN◊ Complete Care in Adults at Risk of Developing Hospital-acquired Pressure Injuries in Critical Care Units
The purpose of this study is to investigate the use of ALLEVYN◊ COMPLETE CARE Sacrum dressing for the prevention of hospital-acquired pressure injuries in adults.
- Trial name
- PACCT (NCT07849387)
- Testing
- ALLEVYN◊ COMPLETE CARE Sacrum
- Where
- 3 sites in United States
- Volunteers
- 330 people
- Sponsor
- Smith & Nephew, Inc.
Pressure Ulcer, Ulcer
Evaluating Several Cellular, Acellular, and Matrix-like Products (CAMPs) and Standard of Care Versus Matched Standard of Care Controls in the Management of Nonhealing Pressure Ulcers
The purpose of this study it to evaluate several cellular, acellular, and matrix-like products (CAMPs) and standard of care versus matched standard of care controls in the management of nonhealing pressure ulcers.
- Conditions
- Pressure Ulcer, Ulcer, Ulcer, Pressure, Pressure Injury
- Trial name
- NCT06999590
- Testing
- ACApatch™, caregraFT™, Standard of Care
- Where
- United States
- Volunteers
- 500 people
- Sponsor
- Tiger Biosciences, LLC.
Hard-to-heal Wounds, Diabetic Foot Ulcer
Clinical Investigation of Sorbact® Dressings
The main purpose of this exploratory clinical investigation is to study the binding of bacteria and fungi from hard-to-heal wounds to the DACC-coated dressings.
- Conditions
- Hard-to-heal Wounds, Diabetic Foot Ulcer, Venous Leg Ulcer, Pressure Ulcer
- Trial name
- NCT05089890
- Testing
- Sorbact® Compress, Sorbact® Gel Dressing, Sorbact® Ribbon Gauze
- Where
- Sweden
- Volunteers
- 30 people
- Sponsor
- ABIGO Medical AB
Tissue Repair, Soft Tissue Reconstruction
Urinary Bladder Matrix (UBM) Registry
The purpose of this registry is to collect real-world information on patients treated with Urinary Bladder Matrix (UBM) products.
- Conditions
- Tissue Repair, Soft Tissue Reconstruction, Wound Management, Pressure Ulcer (PU)
- Trial name
- NCT07805798
- Testing
- Urinary Bladder Matrix (UBM) Products
- Volunteers
- 300 people
- Sponsor
- Integra LifeSciences Corporation
Diabetic Ulcers, Arterial Ulcers
Multicenter, Randomized, Non-inferiority Study to Compare the Performance and Safety of Debrisoft® Duo With Debrisoft® Pad in the Debridement of Wounds
The aim of this post market clinical follow up (PMCF) study is to confirm the performance of Debrisoft® Duo, to collect safety data regarding expected adverse events and to detect potential unexpected adverse events associated…
- Conditions
- Diabetic Ulcers, Arterial Ulcers, Venous Ulcers, Pressure Ulcers
- Trial name
- NCT07312513
- Testing
- two sided debridement pad, one sided debridment pad
- Where
- 5 sites in Poland
- Volunteers
- 100 people
- Sponsor
- Lohmann & Rauscher
Diabetic Foot Ulcer (DFU), Venous Leg Ulcer (VLU)
Evaluation of the Safety and Efficacy of Dehydrated Human Placenta Tissue (dHPT) for Wound Healing
The retrospective trial is observational, intended to stand alone, complement and integrate data collected in ongoing clinical studies to aid in establishing payor coverage in the United States (U.S.) for Cellution Biologics…
- Conditions
- Diabetic Foot Ulcer (DFU), Venous Leg Ulcer (VLU), Pressure Ulcer (PU)
- Trial name
- RETRO-PLAST (NCT07375160)
- Testing
- dHPT, AIC
- Where
- United States
- Volunteers
- 300 people
- Sponsor
- Cellution Biologics
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
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
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
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.
Skin Ulcer, Pressure Ulcer (PU)
Study Title: A Multicenter, Prospective, Modified Platform Trial Evaluating Several Cellular, Acellular, and Matrix-like Products (CAMPs) and Standard of Care Versus Matched Standard of Care Controls in the Management of Nonhealing Pressure Ulcers.
A multicenter prospective modified platform trial evaluating several cellular, acellular, and matrix like products and standard of care versus matched standard of care controls in the management of nonhealing pressure ulcers.
- Conditions
- Skin Ulcer, Pressure Ulcer (PU), Pressure Ulcer of Skin, Pressure Sore
- Trial name
- RESTORE (NCT07665268)
- Testing
- Activate™ Matrix + SOC, AmnioDefend™ FT Matrix + SOC, Palisade™ DM Matrix + SOC
- Where
- United States
- Volunteers
- 2,000 people
- Sponsor
- Sequence LifeScience, Inc.
Chronic Wounds, Burns
THERAVEX Tissue Care Spray Plus for the Management of Cutaneous Wounds, Burns, and Chronic Ulcers
Pilot observational clinical evaluation assessing the safety and potential effectiveness of THERAVEX Tissue Care Spray Plus as an adjunctive topical therapy for the management of cutaneous wounds, burns, traumatic lesions…
- Conditions
- Chronic Wounds, Burns, Pressure Ulcer, Traumatic Wounds
- Trial name
- NCT07617961
- Testing
- THERAVEX TISSUE CARE SPRAY PLUS
- Where
- Spain
- Volunteers
- 26 people, healthy volunteers welcome
- Sponsor
- Biointelligent Technology Systems SL
Pressure Ulcer, Stage IV, Osteomyelitis
A Randomized Controlled Phase II Trial of STIMULAN VG vs Standard of Care (SoC) for the Treatment of Osteomyelitis Associated With Stage IV Pressure Ulcers.
The purpose of this trial is to assess the safety, tolerability and between-group effect size of STIMULAN VG (with debridement) and a course of systemic antibiotics to standard of care (debridement and systemic antibiotics only)…
- Trial name
- BLADE OPU2 (NCT06283979)
- Testing
- STIMULAN VG, Standard of Care
- Where
- 9 sites in United States
- Volunteers
- 60 people
- Sponsor
- Biocomposites Ltd
Pressure Injury
Prospective Case Series Evaluating the Efficacy and Safety of NeoThelium FT for Chronic Pressure Ulcers
This is a prospective case series evaluating the efficacy and safety of NeoThelium FT Amnion Skin Graft in the Mangement of Chronic Pressure Ulcers
- Trial name
- NCT07158658
- Testing
- NeoThelium FT (HCT/P 361)
- Where
- 2 sites in United States
- Volunteers
- 10 people
- Sponsor
- NuScience Medical Biologics, LLC
Pressure Ulcer
Prevention of Pressure Ulcers in Patients at Medium to High Risk of Pressure Ulcers Using the R'GO SOINS Overlay Mattress
The aim of the study is to determine the clinical value of using a powered alternating pressure air overlay mattress (P-APAM) in the prevention of pressure injury (PI) in patients at medium to high risk.
- Trial name
- PRESERVE (NCT06465225)
- Testing
- Use of a powered alternating pressure air mattress
- Where
- France
- Volunteers
- 90 people
- Sponsor
- Nausicaa Medical
Pressure Injury
Evaluating the Efficacy of NeoThelium FT in the Treatment of Pressure Injuries
This is a randomized controlled trial evaluating the efficacy of NeoThelium FT in conjunction with standard of care vs. standard of care alone in treating pressure injuries.
- Trial name
- NCT06918548
- Testing
- Standard of Care, NeoThelium FT
- Volunteers
- 148 people
- Sponsor
- NuScience Medical Biologics, LLC
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
Pressure Injury, Venous Ulcer
MicroMatrix® Flex in Tunneling Wounds
To evaluate the safety and performance of MicroMatrix® Flex in subjects with wounds complicated by tunneling and/or undermining features.
- Conditions
- Pressure Injury, Venous Ulcer, Necrotizing Soft Tissue Infection, Diabetic Ulcers
- Trial name
- NCT06629506
- Testing
- MicroMatrix® Flex, MicroMatrix® UBM Particulate, Cytal® Wound Matrix 2-Layer
- Where
- 3 sites in United States
- Volunteers
- 25 people
- Sponsor
- Integra LifeSciences Corporation