An interventional study of Dynamic Oxygen Skin Therapy (DOST) and Standard Wound Care in Incontinence-associated Dermatitis and Decubitus Ulcer, sponsored by RashEndZ Inc.. Terminated at 1 site in United States. Open to participants aged 21 Years and older. Per ClinicalTrials.gov, last updated 2026-10-27.
Sponsored by RashEndZ Inc. · Not applicable, Interventional, and Device feasibility
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.
To achieve this aim, this study will evaluate the following objectives:
Objective 1:
Assess the safety and tolerability of the RashEndZ therapeutic liner technology with Dynamic Oxygen Skin Therapy for the treatment of Incontinent Associated Dermatitis (IAD) and Decubitus Ulcers (DU) in adult patients.
Objective 2:
Compare treatment responses (symptomatic and clinical) to RashEndZ therapeutic liner technology with Dynamic Oxygen Skin Therapy and current standard of care in patients with IAD and DU
Objective 3:
Compare time course of symptom improvement in IAD and DU patients treated with RashEndZ therapeutic liner technology with Dynamic Oxygen Skin Therapy and current standards of care
The hypotheses to be tested in this study are as follows:
528 studies on the registry are indexed under Pressure Ulcer; 120 are open to participants now.
This study's enrollment of 10 is below the median of 70 across 403 interventional studies indexed under Pressure Ulcer.
Browse Pressure Ulcer studies →This is the only study on the registry with RashEndZ Inc. as lead sponsor.
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Exclusion Criteria:
Application of Dynamic Oxygen Skin Therapy, a non-pressurized, continuous topical oxygen therapy at 3-4 L/min.
Device: Dynamic Oxygen Skin Therapy (DOST)
Application of standard therapies for candidate wound types
Other: Standard Wound Care
Continuous application of respiratory oxygen, at 3-4 L/min, to each wound using the patented RashEndZ Wound Aeration Technology
Also known as: Topical Oxygen Therapy (TOT), RashEndZ Advanced Occlusive Wound Dressing (AOWD)
Existing protocols typically include topical medications and barrier ointments
Number of Participants With Device-Related Adverse Events
Count of participants with adverse events, including skin irritation or patient-reported discomfort, attributed to Dynamic Oxygen Skin Therapy (DOST) delivered via RashEndZ Wound Aeration Technology, recorded on daily assessment datasheets.
Time frame: Start of treatment until wound closure or discharge, up to 8 days
Number of Participants Who Discontinued DOST Due to Intolerance
Count of participants whose DOST treatment was stopped because side effects or adverse events required cessation of DOST and initiation of standard-of-care treatment, per the protocol definition of "poorly tolerated."
Time frame: Start of treatment until end of treatment, up to 8 days
Rate of Change in IADS Score per Treatment Day
Change from baseline in IADS score (range 0-52, lower scores indicate less severe IAD) divided by number of treatment days, to describe the time course of change in each group.
Time frame: Baseline (enrollment) to end of treatment, up to 8 days
Change From Baseline in IADS Score at End of Treatment
Incontinence-Associated Dermatitis Severity (IADS) score (Borchert et al., 2010; range 0-52, lower scores indicate less severe IAD) at end of treatment minus score at enrollment, reported descriptively for each group in participants with IAD.
Time frame: Baseline (enrollment) and end of treatment, up to 8 days
Plan to share: No
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is terminated, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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