N/A N=150 Randomized Treatment

Negative Pressure Wound Therapy as a Drug Delivery System

Diabetic Foot Ulcers

Bottom Line

View on ClinicalTrials.gov: NCT02463487 ↗

Enrolled (actual)

150

Serious AEs

53.3%

Results posted

Aug 2020

Primary outcome: Primary: Number of Participants Who Achieved Complete Healing or Coverage of the Study Wound — 44; 45 Participants — p=0.87

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Cardinal Pro +Simultaneous Irrigation (NPWTi) (Device); Cardinal Pro (NPWT) Therapy (Device)
Age: Adult, Older Adult · 21+ yrs
Sex: All
Sponsor: University of Texas Southwestern Medical Center
Primary completion: Dec 2019

Outcome Measures

Outcome	Result	p-value
PRIMARY Number of Participants Who Achieved Complete Healing or Coverage of the Study Wound	44; 45	0.87
SECONDARY Total Adverse Events of Participants	12; 18; 26; 27; 13; 14	—
SECONDARY Number of Participants With Wound Dehiscence After Hospital Discharge	46; 40	0.08

Summary

The investigators plan a randomized clinical trial of 150 patients with infected diabetes-related lower extremity wounds to compare the clinical and economic effectiveness of negative pressure wound therapy with continuous irrigation and negative pressure wound therapy without irrigation.

Eligibility Criteria

Inclusion Criteria

Diagnosis of diabetes mellitus Men/women ≥21 years old Foot or ankle wounds sized 5 cm2 -100 cm2 ABI≥0.5 or toe pressures >30 mmHg

Exclusion Criteria

Active Charcot arthropathy Unable to use NPWT at home Untreated bone or soft tissue infection Unable to keep research appointments Active alcohol or substance abuse

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Data sourced from ClinicalTrials.gov (NCT02463487). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.