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Dabir Mattress Overlay System for Pressure Sore (DABIRPrU Trial)
N/A
Recruiting
Research Sponsored by SerenaGroup, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 4 week
Awards & highlights
DABIRPrU Trial Summary
This trial will test a mattress overlay system to see if it helps heal full thickness pressure ulcers. The overlay has bluetooth so clinicians can monitor if patients are using it correctly.
Eligible Conditions
- Pressure Sore
DABIRPrU Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 4 week
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~4 week
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Wound Reduction in Surface Area
Secondary outcome measures
Pain assessment
DABIRPrU Trial Design
1Treatment groups
Experimental Treatment
Group I: Dabir Surface Mattress Overlay SystemExperimental Treatment1 Intervention
Eligible patients are treated with a mattress overlay system and standard of care (debridement, proper moisture balance, reduction of bacterial burden and nutritional counseling). Subjects will be seen weekly for 4 weeks. Patients who respond to the offloading device, may use the overlay for an additional 12 weeks with monthly follow-up visits in the clinic or their home. Subjects undergo study procedures on a weekly basis.
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Who is running the clinical trial?
SerenaGroup, Inc.Lead Sponsor
21 Previous Clinical Trials
1,806 Total Patients Enrolled
Dabir Surfaces IncIndustry Sponsor
2 Previous Clinical Trials
407 Total Patients Enrolled
Laura SerenaStudy Directorcro
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there any enrollment opportunities currently available for this research project?
"As evidenced by clinicaltrials.gov, this medical research is presently recruiting participants. The trial began on October 4th 2021 and the last update was November 3rd 2022."
Answered by AI
What is the current enrollment capacity for this clinical trial?
"Affirmative, clinicaltrials.gov's records show that this trial is actively looking for patients to join. The initial posting was on October 4th 2021 and the most recent update came November 3rd 2022. Specifically, 30 participants are needed from a single medical facility."
Answered by AI
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