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Dallas, Texas 75390

  • Ulcer

Purpose:

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. Primary outcomes will include rates of wound healing, time to closure by secondary intention, and recurrence rate.


Study summary:

Subjects will be taken to the operating room for the initial debridement procedure of the wound. At the end of the procedure, subjects who continue to meet all inclusion and no exclusion criteria will be randomized in a 1:1:1 ratio to be treated with either PRO, PRO with simultaneous irrigation (PROI), or KCI Ulta NPWT. Prior to study initiation sealed prenumbered randomization envelopes will be provided to the research staff and used to obtain randomization assignment. Opening of the randomization envelop will occur intraoperatively at the conclusion of the initial surgical debridement of the wound and conformation of all eligibility requirements. Study staff will use the randomization number labels contained in the envelop. The number will become the subject ID. The assignment will be subjects randomized to PRO, PRO with simultaneous irrigation, or KCI Ulta NPWT. The research staff will note treatment assignments on the intra operative randomization CRF and instruct the investigator. Treatment therapy wound dressings will be applied in the operating room or in the patient's room immediately after surgery per the investigators discretion, according to the manufacturer's recommendations. In order to ensure consistent study treatment, subjects will receive assigned treatment therapies within their study arm after the initial and any subsequent surgical debridements until the wound is deemed ready for closure or coverage by the Investigator. Subjects randomized to the PRO with simultaneous irrigation Treatment arm are the only subjects that will receive irrigation therapy at any time during the study treatment period. If irrigation therapy is discontinued, subjects in the Treatment arm will transition to PRO NPWT without irrigation. Subjects randomized to the PRO Control arm will receive NPWT only from the PRO therapy unit.


Criteria:

Inclusion Criteria: - 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. - 18 years of age or older Exclusion Criteria: - 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 - Current melanoma or history of melanoma at the wound - Current active or history of invasive squamous cell carcinoma at the wound - Sepsis (defined as positive blood culture with leukocytosis) and temperature >101.5 at the time of screening - Significant Hematologic disorders EXCLUDING anemia - HIV - Fever at screening > 101.5 - Deep X-ray therapy - Untreated bone or soft tissue infection (osteomyelitis) - Any concomitant illness(es) or medical condition(s) that in the opinion of the investigator would render the subject not suited for study participation - Subject is taking a regimen of any medication(s) in a significant enough dosage that may affect chronic wound healing, including corticosteroid, chemotherapeutic and non-steroidal anti-inflammatory (NSAID) medications - Less than 18 years of age - Developmental disability/significant psychological disorder that could impair the subject's ability to provide informed consent, participate in the study protocol or record study measures, including schizophrenia, bipolar disorder and psychiatric hospitalization within the last 2 years. - Females currently pregnant or planning pregnancy during the course of intended participation in the study - Active alcohol or substance abuse in the opinion of the investigator that could impair the subjects ability to provide informed consent, participate in the study protocol or record study measures.


Study is Available At:


Original ID:

032015-099


NCT ID:

NCT02519621


Secondary ID:


Study Acronym:


Brief Title:

NPWT PRO vs KCI Ulta® NPWT and to Compare NPWT PRO vs NPWT PRO With Simultaneous Irrigation on Wound Healing


Official Title:

A Pilot Study to Compare the Efficacy of NPWT PRO Versus KCI Ulta® NPWT and to Compare NPWT PRO Versus NPWT PRO With Simultaneous Irrigation on Wound Healing


Overall Status:

Active, not recruiting


Study Phase:

N/A


Genders:

N/A


Minimum Age:

18 Years


Maximum Age:

89 Years


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

University of Texas Southwestern Medical Center


Oversight Authority:

United States: Institutional Review Board


Reasons Why Stopped:


Study Type:

Interventional


Study Design:


Number of Arms:

3


Number of Groups:

0


Total Enrollment:

90


Enrollment Type:

Anticipated


Overall Contact Information

Official Name:Lawrence A Lavery, DPM
Principal Investigator
UT Southwestern Medical Center

Study Dates

Start Date:April 2016
Completion Date:December 2019
Completion Type:Anticipated
Primary Completion Date:January 2019
Primary Completion Type:Actual
Verification Date:February 2019
Last Changed Date:February 25, 2019
First Received Date:June 1, 2015

Study Outcomes

Outcome Type:Primary Outcome
Measure:Rate of healing as measured by wound imaging (acetate tracing, photo, ARANZ)
Time Frame:12 weeks
Safety Issues:False
Description:Comparison of reduction in wound volume between wounds treated with NPWT PRO versus KCI Ulta® NPWT and to Compare NPWT PRO versus NPWT PRO with Simultaneous Irrigation
Outcome Type:Primary Outcome
Measure:Time to closure by secondary intention
Time Frame:12 weeks
Safety Issues:False
Description:Number of wounds ready for closure by secondary intention
Outcome Type:Primary Outcome
Measure:Number of wounds that recur within 1 year after completion of the study
Time Frame:1 year
Safety Issues:False
Description:Number of wounds that recur within 1 year after completion of the study
Outcome Type:Secondary Outcome
Measure:Reduction in bacterial load in wounds treated with NPWT and NPWT with simultaneous irrigation.
Time Frame:Week12
Safety Issues:False
Description:Reduction in bacterial load in wounds treated with NPWT and NPWT with simultaneous irrigation.
Outcome Type:Secondary Outcome
Measure:Changes in molecular markers associated with wound healing and regeneration of healthy tissue
Time Frame:Week12
Safety Issues:False
Description:Analysis of growth factors, cytokines, and other molecular markers in wounds treated with NPWT and NPWT with simultaneous irrigation.

Study Interventions

Intervention Type:Device
Name:NPWT PRO without irrigation
Description:NPWT PRO without irrigation.
Arm Name:NPWT PRO without irrigation
Other Name:Cardinal Quantum NPWT PRO
Intervention Type:Device
Name:NPWT PRO with irrigation
Description:NPWT PRO with irrigation (saline)
Arm Name:NPWT PRO with Irrigation
Other Name:Cardinal Quantum NPWT PRO
Intervention Type:Device
Name:KCI Ulta
Description:KCI Ulta NPWT without irrigation
Arm Name:KCI Ulta NPWT

Study Arms

Study Arm Type:Active Comparator
Arm Name:NPWT PRO without irrigation
Description:Cardinal Health NPWT PRO system (K143016) continuous/intermittent vacuum-assisted drainage
Study Arm Type:Active Comparator
Arm Name:NPWT PRO with Irrigation
Description: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).
Study Arm Type:Active Comparator
Arm Name:KCI Ulta NPWT
Description:KCI Ulta NPWT without irrigation.

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:Larry Lavery

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: April 03, 2020

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