NCT02519621

Brief 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
90

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2016

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 1, 2015

Completed
2 months until next milestone

First Posted

Study publicly available on registry

August 11, 2015

Completed
8 months until next milestone

Study Start

First participant enrolled

April 1, 2016

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2019

Completed
1.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 24, 2020

Completed
2 months 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

2.8 years

First QC Date

June 1, 2015

Results QC Date

July 17, 2020

Last Update Submit

July 20, 2023

Conditions

Partial-thickness BurnUlcer

Keywords

diabetic ulcerpressure ulcerchronic or traumatic woundsub-acute or dehisced wound

Outcome Measures

Primary Outcomes (1)

  • Number of Participants Who Achieved Complete Wound Healing

    Complete healing of wounds as defined by epithelialization with no drainage in three treatment arms: NPWT PRO versus KCI Ulta® NPWT and to Compare NPWT PRO versus NPWT PRO with Simultaneous Irrigation

    12 weeks

Secondary Outcomes (3)

  • Number of Surgeries

    12 weeks

  • Length of Stay

    12 weeks

  • Days to Heal

    12 weeks

Study Arms (3)

NPWT PRO without irrigation

ACTIVE COMPARATOR

Cardinal Health NPWT PRO system (K143016) continuous/intermittent vacuum-assisted drainage

Device: NPWT PRO without irrigation

NPWT PRO with Irrigation

ACTIVE COMPARATOR

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).

Device: NPWT PRO with irrigation

KCI Ulta NPWT

ACTIVE COMPARATOR

KCI Ulta NPWT without irrigation.

Device: KCI Ulta

Interventions

NPWT PRO without irrigationDEVICE

NPWT PRO without irrigation.

Also known as: Cardinal Quantum NPWT PRO
NPWT PRO without irrigation
NPWT PRO with irrigationDEVICE

NPWT PRO with irrigation (saline)

Also known as: Cardinal Quantum NPWT PRO
NPWT PRO with Irrigation
KCI UltaDEVICE

KCI Ulta NPWT without irrigation

KCI Ulta NPWT

Eligibility Criteria

Age18 Years - 89 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Presents with an existing chronic or traumatic wound, sub-acute or dehisced wound, partial-thickness burn, ulcer (such as a diabetic or pressure ulcer), flap or graft as diagnosed by a qualified and certified medical practitioner (M.D., D.O., or D.P.M)
  • Wound presents with full thickness loss of epidermis and dermis
  • The presentation of a wound that in the opinion of the investigators will require surgical debridement, and the wound is expected to be a good candidate for NPWT and eventual wound closure.
  • ABI≥0.5 or toe pressures \>30 PVR/mmHg
  • Subject is willing and able to abstain from partaking in any other form of treatment for his or her wound throughout the duration of his or her course of participation in the clinical study, other than the study procedures described herein.
  • years of age or older

You may not qualify if:

  • Does not present with an existing chronic or traumatic wound, sub-acute or dehisced wound, partial-thickness burn, ulcer (such as a diabetic or pressure ulcer), flap or graft, or a definitive diagnosis cannot be made, as diagnosed by a qualified and certified medical practitioner (M.D., D.O., or D.P.M)
  • Wound does not present with full thickness loss of epidermis and dermis
  • ABI\<0.5 or toe pressures \<30 PVR/mmHg
  • Subject is not willing or is not able or it is not medically prudent for the subject to abstain from partaking in any other form of treatment for his or her wound throughout the duration of his or her course of participation in the clinical study, other than the study procedures described.
  • Subject is unwilling or unable to use the NPWT device at home
  • Active Charcot arthropathy
  • Collagen vascular disease
  • Scleroderma
  • Non-enteric and unexplored fistula
  • Necrotic tissue with eschar present after debridement
  • General skin disorder in the area of the wound such as psoriasis or penicilitis
  • Malnutrition (defined as BMI \<19)
  • Hypercoagulable state based on documentation in their medical record
  • Acute deep vein thrombosis
  • Current active malignancy in the wound
  • +14 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

UT Southwestern Medical Center

Dallas, Texas, 75390, United States

Location

UT Southwestern

Dallas, Texas, 75390, United States

Location

MeSH Terms

Conditions

UlcerPressure UlcerBronchiolitis Obliterans Syndrome

Interventions

Therapeutic Irrigation

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and SymptomsSkin UlcerSkin DiseasesSkin and Connective Tissue DiseasesOrganizing PneumoniaBronchiolitis ObliteransBronchiolitisBronchitisBronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesGraft vs Host DiseaseImmune System Diseases

Intervention Hierarchy (Ancestors)

HydrotherapyPhysical Therapy ModalitiesTherapeuticsRehabilitationInvestigative 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
SPONSOR INVESTIGATOR
PI Title
Professor and Director of Research

Study Record Dates

First Submitted

June 1, 2015

First Posted

August 11, 2015

Study Start

April 1, 2016

Primary Completion

January 1, 2019

Study Completion

June 24, 2020

Last Updated

July 24, 2023

Results First Posted

August 14, 2020

Record last verified: 2023-07

Locations

US(2)