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Negative Pressure Wound Therapy Device

NPWT PRO with Irrigation for Ulcer

N/A
Waitlist Available
Led By Lawrence A Lavery, DPM
Research Sponsored by Larry Lavery
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 12 weeks
Awards & highlights

Study Summary

This study is designed to assess the efficacy and economics of two NPWT (negative pressure wound therapy) branded devices of wound healing outcomes. It is also designed to assess the effectiveness of negative pressure and negative pressure with continuous irrigation on multiple parameters of wound healing. It is a single-center, open-label, active controlled, parallel-group trial that aims to determine the efficacy of Quantum with simultaneous irrigation in the treatment of diabetic foot ulcers. Specifically, eligible participants will be randomized to receive either PRO negative press therapy with simultaneous irrigation; or PRO negative pressure therapy without irrigation; or KCI Ulta negative pressure therapy. Outcomes will include rates of wound healing, time to closure, number of surgeries, length of stay, and days to heal.

Eligible Conditions
  • Partial Thickness Burns
  • Ulcer

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Number of Participants Who Achieved Complete Wound Healing
Secondary outcome measures
Days to Heal
Length of Stay
Number of Surgeries

Trial Design

3Treatment groups
Active Control
Group I: NPWT PRO with IrrigationActive Control1 Intervention
Cardinal Health NPWT PRO system (K143016) continuous/intermittent vacuum-assisted drainage with simultaneous delivery of topical wound treatment solutions and suspensions over the wound bed (saline irrigant).
Group II: NPWT PRO without irrigationActive Control1 Intervention
Cardinal Health NPWT PRO system (K143016) continuous/intermittent vacuum-assisted drainage
Group III: KCI Ulta NPWTActive Control1 Intervention
KCI Ulta NPWT without irrigation.

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Who is running the clinical trial?

Larry LaveryLead Sponsor
Lawrence A Lavery, DPMPrincipal InvestigatorUT Southwestern Medical Center
3 Previous Clinical Trials
233 Total Patients Enrolled
1 Trials studying Ulcer
23 Patients Enrolled for Ulcer
~10 spots leftby Jun 2025
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