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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
No Placebo-Only Group

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

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~4 week
This trial's timeline: 3 weeks for screening, Varies for treatment, and 4 week for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Wound Reduction in Surface Area
Secondary study objectives
Pain assessment

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

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
29 Previous Clinical Trials
3,398 Total Patients Enrolled
Dabir Surfaces IncIndustry Sponsor
2 Previous Clinical Trials
407 Total Patients Enrolled
Laura SerenaStudy Directorcro
~7 spots leftby Oct 2025
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