Clinical trials: Pressure Sores
Stage IV Pressure Ulcer, Diabetic Foot Osteomyelitis
Expanded Access Program (EAP) STIMULAN VG
Individual (single) patient expanded access may be considered.
- Trial name
- EAPSTIMVG (NCT06808568)
- Testing
- STIMULAN VG
- Sponsor
- Biocomposites Ltd
Venous Leg Ulcer, Pressure Ulcer
Confirm Safety and Performance of Avance Solo and Avance Solo Adapt NPWT Systems
The primary objective of this post market clinical follow-up (PMCF) investigation is to confirm the safety and performance of Avance®Solo and Avance®Solo Adapt NPWT Systems in low to moderate exuding chronic wounds when used in…
- Conditions
- Venous Leg Ulcer, Pressure Ulcer, Diabetic Foot Ulcer, Chronic Ulcer
- Trial name
- ASOLO-CW (NCT04753294)
- Testing
- Avance Solo NPWT System, Avance Solo Adapt NPWT System
- Where
- 13 sites in Belgium, Denmark and 5 more
- Volunteers
- 136 people
- Sponsor
- Molnlycke Health Care AB
Venous Leg Ulcer, Diabetic Foot Ulcer
EUREKA Italy - Evaluation of Real-life Use of KLOX BioPhotonic System in Chronic Wounds Management
Multi-center, prospective, interventional, uncontrolled open-label study evaluating the real-life use of KLOX LumiHeal BioPhotonic System in chronic wounds management (venous leg ulcers, diabetic foot ulcers, pressure ulcers).
- Conditions
- Venous Leg Ulcer, Diabetic Foot Ulcer, Pressure Ulcer
- Trial name
- NCT03021811
- Testing
- KLOX LumiHeal BioPhotonic System
- Volunteers
- 100 people
- Sponsor
- KLOX Technologies Inc.
Pressure Injury, Fall Prevention
Clinical Investigation Evaluating the Use of NETSmart Solution , Incorporated to NETSoins Software, in the Care and Support of Elderly People Living in Nursing Homes
NETSmart software is designed to help doctors, nurses and care assistants adapt the care of elderly people living in nursing homes to the following risks: pressure injuries undernutrition interactions between different drugs…
- Conditions
- Pressure Injury, Fall Prevention, Undernutrition, Drug Interaction
- Trial name
- NETSMART DM (NCT07027358)
- Testing
- NETSmart software
- Where
- France
- Volunteers
- 30 people
- Sponsor
- Teranga Software
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
Pressure Injury Prevention
Evaluation of Commercially Available Heel Pads for the Prevention of Pressure Ulcers: An Observational Study of Incidence and Usability in Adult Surgical Patients.
This study will evaluate the incidence of heel pressure ulcers in adult patients undergoing elective surgery while using the Oasis Elite Heel Pad (EL130) as part of routine pressure ulcer prevention.
- Trial name
- NCT07852897
- Testing
- Oasis Elite Heel Pad (EL130)
- Where
- Ireland
- Volunteers
- 35 people, healthy volunteers welcome
- Sponsor
- Trulife
Venous Ulcers, Bedsores
HealiAid in the Treatment of Different Wounds
The goal of this open-label, post-market clinical follow-up study is to demonstrate the safety and effectiveness of HealiAid Collagen Wound Dressing in patients classified into different types of wounds: venous ulcers, bedsores…
- Conditions
- Venous Ulcers, Bedsores, Diabetic Foot Wound, Burn Wound
- Trial name
- NCT06280053
- Testing
- HealiAid Collagen Wound Dressing
- Volunteers
- 18 people
- Sponsor
- Maxigen Biotech Inc.
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
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
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
Chronic Pressure Ulcers
PuraPly® AM Plus the Standard of Care to Standard of Care Alone for the Management of Stage II-IV Pressure Ulcers.
This is a prospective, multi-center, randomized, controlled clinical study Of PuraPly® AM and standard of care (SOC) compared to SOC alone for the management of Stage II-IV pressure ulcers located in the gluteal, ischial, hip…
- Trial name
- NCT03502824
- Testing
- PuraPly® Antimicrobial Wound Matrix, SOC for Pressure Ulcers
- Where
- 2 sites in United States
- Volunteers
- 40 people
- Sponsor
- Organogenesis
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
Efficacy of Quantum NPWT With Simultaneous Irrigation on Reduction of Wound Volume in Stage III/IV Pressure Ulcers.
Negative-pressure wound therapy (NPWT) is an important adjunct for management of wounds, and promotes granulation tissue and angiogenesis.
- Trial name
- NCT01734109
- Testing
- Quantum Negative Pressure Wound Therapy Device
- Where
- United States
- Volunteers
- 90 people
- Sponsor
- Innovative Therapies, Inc.
Skin Lesion, Traumatic Ulcer
Clinical Investigation EUCLIDES-01 for the Calculation of the Area of Skin Lesions
The aim of this clinical investigation is to collect skin lesion area data for the comparison of the agreement among the results obtained between the following three wound area measurement methods: Ruler using the Kundin method…
- Conditions
- Skin Lesion, Traumatic Ulcer, Hematoma, Pressure Ulcer
- Trial name
- NCT05729334
- Testing
- Clinicgram Euclides
- Where
- Spain
- Volunteers
- 65 people
- Sponsor
- Skilled Skin S.L.
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.
Pressure Ulcers, Venous Ulcers
Prospective PuraPly™ AM Case Series Study
The PuraPly AM case series is a prospective, observational study for patients who have received PuraPly AM which consists of a collagen sheet coated with polyhexamethylene biguanide hydrochloride (PHMB) and is intended for the…
- Conditions
- Pressure Ulcers, Venous Ulcers, Diabetic Ulcers, Surgical Wounds
- Trial name
- NCT03070925
- Testing
- PuraPly™ Antimicrobial Wound Matrix
- Where
- United States
- Volunteers
- 43 people
- Sponsor
- Organogenesis
Pressure Ulcer, Diabetic Foot Ulcer
Efficacy of Wound Dressings With Copper Oxide
Thirty patients of 18-85 years of age, with 2-30 cm2 pressure ulcers or post-op wounds, will be recruited and treated with either wound dressing containing silver or wound dressings containing copper oxide microparticles.
- Trial name
- NCT04634838
- Testing
- MedCu Antibacterial Wound Dressings with Copper Oxide
- Where
- Israel
- Volunteers
- 20 people
- Sponsor
- MedCu Technologies Ltd.
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 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 Ulcers
A Pilot Study of the Envision® Surface
This study is to evaluate the clinical safety and effectiveness of the Envision® surface.
- Trial name
- NCT00405834
- Testing
- Envision® Patient Support System
- Where
- United States
- Volunteers
- 30 people
- Sponsor
- Hill-Rom