NCT02463487

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2015

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 16, 2015

Completed
2 months until next milestone

Study Start

First participant enrolled

June 2, 2015

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 4, 2015

Completed
4.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 28, 2019

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2020

Completed
13 days until next milestone

Results Posted

Study results publicly available

August 14, 2020

Completed
Last Updated

July 24, 2023

Status Verified

July 1, 2023

Enrollment Period

4.6 years

First QC Date

April 16, 2015

Results QC Date

July 24, 2020

Last Update Submit

July 20, 2023

Conditions

Diabetic Foot Ulcers

Outcome Measures

Primary Outcomes (1)

  • Number of Participants Who Achieved Complete Healing or Coverage of the Study Wound

    How many wounds fully healed in 16 weeks. Healing defined as fully epithelialized skin with no drainage.

    16 weeks

Secondary Outcomes (2)

  • Total Adverse Events of Participants

    16 Weeks

  • Number of Participants With Wound Dehiscence After Hospital Discharge

    16 weeks

Study Arms (2)

Cardinal Pro + Irrigation (NPWTi)

ACTIVE COMPARATOR

Negative Pressure Wound Therapy with Irrigation: Quantum™ +Simultaneous Irrigation (NPWTi) - Negative Pressure Wound Therapy with Prontosan® Intervention is receiving the Cardinal Vac with Irrigation

Device: Cardinal Pro +Simultaneous Irrigation (NPWTi)

Cardinal Pro (NPWT) Therapy

ACTIVE COMPARATOR

Negative Pressure Wound Therapy without Irrigation: Quantum™ (NPWT) -Negative Pressure Wound Therapy (without Prontosan®) Intervention is receiving the Cardinal Vac without Irrigation

Device: Cardinal Pro (NPWT) Therapy

Interventions

Cardinal Pro +Simultaneous Irrigation (NPWTi)DEVICE

NPWT with low volume irrigation (15 cc/hr) with 1% polyhexanide biguanide (PHMB), Prontosan®

Also known as: • Negative Pressure Wound Therapy with Irrigation
Cardinal Pro + Irrigation (NPWTi)
Cardinal Pro (NPWT) TherapyDEVICE

NPWT 125 mm Hg continuous pressure with foam interface

Also known as: • Negative Pressure Wound Therapy without Irrigation
Cardinal Pro (NPWT) Therapy

Eligibility Criteria

Age21 Years - 89 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UT Southwestern Medical Center at Dallas

Dallas, Texas, 75390, United States

Location

Related Publications (1)

  • Lavery LA, Davis KE, La Fontaine J, Farrar JD, Bhavan K, Oz OK, Crisologo PA. Does negative pressure wound therapy with irrigation improve clinical outcomes? A randomized clinical trial in patients with diabetic foot infections. Am J Surg. 2020 Oct;220(4):1076-1082. doi: 10.1016/j.amjsurg.2020.02.044. Epub 2020 Feb 27.

    PMID: 32139102DERIVED

MeSH Terms

Conditions

Diabetic Foot

Interventions

Negative-Pressure Wound TherapyTherapeutic IrrigationTherapeutics

Condition Hierarchy (Ancestors)

Diabetic AngiopathiesVascular DiseasesCardiovascular DiseasesFoot UlcerLeg UlcerSkin UlcerSkin DiseasesSkin and Connective Tissue DiseasesDiabetes ComplicationsDiabetes MellitusEndocrine System DiseasesDiabetic Neuropathies

Intervention Hierarchy (Ancestors)

DrainageSurgical Procedures, OperativeWound Closure TechniquesHydrotherapyPhysical Therapy ModalitiesRehabilitationInvestigative Techniques

Results Point of Contact

Title
Lawrence Lavery, DPM, MPH
Organization
UT Southwestern Medical Center at Dallas
Larry.Lavery@UTSouthwestern.edu
214-645-0544

Study Officials

  • Lawrence A Lavery, DPM

    University of Texas Southwestern Medical Center

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor, Department of Plastic Surgery

Study Record Dates

First Submitted

April 16, 2015

First Posted

June 4, 2015

Study Start

June 2, 2015

Primary Completion

December 28, 2019

Study Completion

August 1, 2020

Last Updated

July 24, 2023

Results First Posted

August 14, 2020

Record last verified: 2023-07

Locations

US(1)