Clinical trials: Pressure Ulcer of Skin
Pressure Ulcer, Diabetes Mellitus
A Study of GM-XANTHO in Pressure Ulcer Patients
This is a randomized, placebo-controlled, double-blind, 3-arm, single-center, phase IIa, parallel study to assess the efficacy, safety, and tolerability of topically applied 2.5%, 5% GM-XANTHO plus standard of care in patients…
- Trial name
- NCT05199077
- Testing
- GM-XANTHO
- Where
- Taiwan
- Volunteers
- 58 people
- Sponsor
- Xantho Biotechnology Co., LTD
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.
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.
Plantar Ulcer, Diabetes
The CareFUL Prevention Trial
To assess the efficacy of TrueContour® Insoles versus the current standard of care insoles in recurrence of plantar MTH ulcers in men and women, 18 years of age or older at the time of consent with clinical diagnosis of Diabetes…
- Conditions
- Plantar Ulcer, Diabetes, Neuropathy Causing Loss of Protective Sensation
- Trial name
- CareFULPrevent (NCT00803608)
- Testing
- TrueContour® Insole, Current standard of care insole
- Where
- 11 sites in United States
- Volunteers
- 130 people
- Sponsor
- DIApedia, LLC
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
Pressure Ulcers Stage III, Pressure Ulcer, Stage IV
Comparing Concomitant Use of ACell MicroMatrix® and ACell Cytal™ to Standard of Care in Stage 3 or 4 Pressure Injuries
The purpose of this study is to evaluate incidence of complete epithelialization in stage 3 \& 4 pressure ulcers using ACell products.
- Conditions
- Pressure Ulcers Stage III, Pressure Ulcer, Stage IV, Pressure Ulcer
- Trial name
- NCT03283787
- Testing
- MicroMatrix® and Cytal™ Wound Matrix 2-Layer, MicroMatrix® and Cytal™ Wound Matrix 2-Layer plus NPWT, Negative Pressure Wound Therapy
- Where
- United States
- Volunteers
- 60 people
- Sponsor
- Integra LifeSciences Corporation
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
Diabetic Foot Ulcer, Venous Leg Ulcer
ChitoCare Medical Wound Healing Gel PMCF Study on Healing of Chronic Wounds
We are testing a gel intended for the protection and healing of chronic wounds as a support for standard therapy. The main component of the gel is chitosan, a natural polymer that has the ability to stop bleeding, has a positive…
- Conditions
- Diabetic Foot Ulcer, Venous Leg Ulcer, Pressure Ulcer
- Trial name
- CHITOCHRONIC (NCT05570877)
- Testing
- ChitoCare medical Wound Healing Gel
- Where
- 9 sites in Croatia, Slovenia
- Volunteers
- 92 people
- Sponsor
- Primex ehf
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
Evaluate the Noninferiority of Medicines Treating Uninfected Pressure Ulcers.
This is a Clinical study Phase III, Prospective, Randomized, Controlled, Double-blind, Multicenter, National, Non-inferiority. Its purpose is to determine the noninferiority in efficacy of an investigational product in relation…
- Trial name
- NCT02004626
- Testing
- Collagenase, Kollagenase
- Where
- Brazil
- Sponsor
- Cristália Produtos Químicos Farmacêuticos Ltda.
Burn Wound, Pressure Ulcers Stage II
Study to Evaluate the Performance and Safety of the Medical Device Argogen
A wound, i.e., a break in the skin, can result from several reasons. Pressure ulcers (also called pressure sores, bed sores and decubitus ulcers) are localized damage to the skin and underlying soft tissue usually over a bony…
- Conditions
- Burn Wound, Pressure Ulcers Stage II, Pressure Ulcers Stage III
- Trial name
- NCT05649332
- Testing
- Argogen (silver zeolite powder)
- Where
- 2 sites in Romania
- Volunteers
- 58 people
- Sponsor
- Signorini Medicale S.r.l.
Pressure Ulcer
Phage Therapy for the Prevention and Treatment of Pressure Ulcers.
This study will evaluate a topical bacteriophage therapy product (BACTELIDE) as an adjunct to standard therapy for the prevention and treatment of pressure ulcers colonized with S. aureus, P. aeruginosa, or K. pneumoniae species.
- Trial name
- NCT04815798
- Testing
- Bacteriophage-loaded Microcapsule Spray, Standard of Care
- Volunteers
- 69 people
- Sponsor
- Precisio Biotix Therapeutics, Inc.
Heel Pressure Ulceration Prevention Strategies
Evaluation of Heel Offloading Devices for Reducing Heel Contact Pressures in Healthy Volunteers
Prevention of heel pressure ulceration is a major clinical concern. Clinical research has shown that heel-offloading devices are effective at preventing heel ulceration when compared to no offloading or sub-optimal offloading…
- Trial name
- NCT02811965
- Testing
- Pillow Condition 1, Pillow Condition 2, Heel Foam Pillow
- Where
- United States
- Volunteers
- 21 people, healthy volunteers welcome
- Sponsor
- DeRoyal Industries, Inc.
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.
Diabetic Foot Ulcer, Pressure Injury
Evaluating Clinical Acceptance of a NPWT Wound Care System
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
- Trial name
- NCT03670225
- Testing
- Invia Motion Endure
- Where
- United States
- Volunteers
- 10 people
- Sponsor
- Medela AG
Patient Positioning, Monitoring, Physiologic
An Assessment of the Zephyr BioPatch and Its Ability to Monitor Patient Position
The primary objective of the study is to examine the effectiveness of the Zephyr BioPatch in measuring position changes of a non-patient subject in a lab setting and to examine the effectiveness of the Zephyr BioPatch in…
- Conditions
- Patient Positioning, Monitoring, Physiologic, Pressure Ulcer
- Trial name
- NCT02548624
- Testing
- Zephyr BioPatch
- Where
- United States
- Volunteers
- healthy volunteers welcome
- Sponsor
- Medtronic - MITG
Pressure Ulcers
Study of Thymosin Beta 4 in Patients With Pressure Ulcers
The purpose of this study is to evaluate the safety, tolerability and effectiveness of Thymosin Beta 4 administered topically in patients with Pressure Ulcers
- Trial name
- NCT00382174
- Testing
- Thymosin Beta 4
- Where
- 12 sites in United States
- Volunteers
- 72 people
- Sponsor
- RegeneRx Biopharmaceuticals, Inc.
Venous Leg Ulcer (VLU)
Assessing Sensor-Guided Compression Therapy for Venous Leg Ulcers Healing Outcomes
The investigators are conducting a study to find out if a new system can help improve the care of people with venous leg ulcers (VLU).
- Trial name
- NCT07268482
- Testing
- A connected-health, pressure-sensing system for monitoring sub-bandage pressure during compression therapy
- Where
- Ireland
- Volunteers
- 40 people
- Sponsor
- Feeltect 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.
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.