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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.
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 envelope 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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| NPWT PRO without irrigation | Active Comparator | Cardinal Health NPWT PRO system (K143016) continuous/intermittent vacuum-assisted drainage |
|
| 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). |
|
| KCI Ulta NPWT | Active Comparator | KCI Ulta NPWT without irrigation. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NPWT PRO without irrigation | Device | NPWT PRO without irrigation. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Surgeries | Number of surgeries required to debride infection before wound was ready for closure or coverage. | 12 weeks |
| Length of Stay | Number of days the patient stayed in the hospital |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Lawrence A Lavery, DPM | University of Texas Southwestern Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UT Southwestern Medical Center | Dallas | Texas | 75390 | United States | ||
| UT Southwestern |
93 were consented but 3 of them did not have the vac/treatment, so therefore 90 total (30 in each group).
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| ID | Title | Description |
|---|---|---|
| FG000 | NPWT PRO Without Irrigation | Cardinal Health NPWT PRO system (K143016) continuous/intermittent vacuum-assisted drainage NPWT PRO without irrigation: NPWT PRO without irrigation. |
| FG001 | NPWT PRO With Irrigation | 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). NPWT PRO with irrigation: NPWT PRO with irrigation (saline) |
| FG002 | KCI Ulta NPWT | KCI Ulta NPWT without irrigation. KCI Ulta: KCI Ulta NPWT without irrigation |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | NPWT PRO Without Irrigation | Cardinal Health NPWT PRO system (K143016) continuous/intermittent vacuum-assisted drainage NPWT PRO without irrigation: NPWT PRO without irrigation. |
| BG001 | NPWT PRO With Irrigation |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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 | Posted | Count of Participants | Participants | 12 weeks |
|
Adverse events during 12 weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | NPWT PRO Without Irrigation | Cardinal Health NPWT PRO system (K143016) continuous/intermittent vacuum-assisted drainage NPWT PRO without irrigation: NPWT PRO without irrigation. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Foot related readmission | Infections and infestations | Systematic Assessment | Serious adverse event - readmission to the hospital for foot-related problem. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Reinfection of study foot | Infections and infestations | Systematic Assessment | New infection of the study foot during the study |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Lawrence Lavery, DPM, MPH | UT Southwestern Medical Center at Dallas | 214-645-0544 | Larry.Lavery@UTSouthwestern.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jun 5, 2020 | Jul 17, 2020 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D014456 | Ulcer |
| D003668 | Pressure Ulcer |
| D000092122 | Bronchiolitis Obliterans Syndrome |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012883 | Skin Ulcer |
| D012871 | Skin Diseases |
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| ID | Term |
|---|---|
| D007507 | Therapeutic Irrigation |
| ID | Term |
|---|---|
| D006875 | Hydrotherapy |
| D026741 | Physical Therapy Modalities |
| D013812 | Therapeutics |
| D012046 | Rehabilitation |
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| NPWT PRO with irrigation | Device | NPWT PRO with irrigation (saline) |
|
|
| KCI Ulta | Device | KCI Ulta NPWT without irrigation |
|
| 12 weeks |
| Days to Heal | The number of days to heal the wound after last surgery was performed. | 12 weeks |
| Dallas |
| Texas |
| 75390 |
| United States |
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).
NPWT PRO with irrigation: NPWT PRO with irrigation (saline)
| BG002 | KCI Ulta NPWT | KCI Ulta NPWT without irrigation. KCI Ulta: KCI Ulta NPWT without irrigation |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG002 | KCI Ulta NPWT | KCI Ulta NPWT without irrigation. KCI Ulta: KCI Ulta NPWT without irrigation |
|
|
| Secondary | Number of Surgeries | Number of surgeries required to debride infection before wound was ready for closure or coverage. | Posted | Mean | Standard Deviation | surgeries | 12 weeks |
|
|
|
| Secondary | Length of Stay | Number of days the patient stayed in the hospital | Posted | Mean | Standard Deviation | days | 12 weeks |
|
|
|
| Secondary | Days to Heal | The number of days to heal the wound after last surgery was performed. | Posted | Mean | Standard Deviation | days | 12 weeks |
|
|
|
| 0 |
| 30 |
| 4 |
| 30 |
| 4 |
| 30 |
| EG001 | NPWT PRO With Irrigation | 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). NPWT PRO with irrigation: NPWT PRO with irrigation (saline) | 0 | 30 | 4 | 30 | 5 | 30 |
| EG002 | KCI Ulta NPWT | KCI Ulta NPWT without irrigation. KCI Ulta: KCI Ulta NPWT without irrigation | 0 | 30 | 4 | 30 | 5 | 30 |
|
|
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| D017437 | Skin and Connective Tissue Diseases |
| D000092124 | Organizing Pneumonia |
| D001989 | Bronchiolitis Obliterans |
| D001988 | Bronchiolitis |
| D001991 | Bronchitis |
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D006086 | Graft vs Host Disease |
| D007154 | Immune System Diseases |
| D008919 |
| Investigative Techniques |