Single-Use Negative Pressure Wound Therapy System vs. Traditional Negative Pressure Wound Therapy System (tNPWT)

Overview

The aim of this study is to compare the clinical efficacy of two types of NPWT systems; the traditional negative pressure wound therapy (tNPWT) system and the single-use negative pressure wound therapy (PICO) system.

Full Title of Study: “A Prospective, Randomized, Comparative Effectiveness Study of a Single-Use, Negative Pressure Wound Therapy System (PICO) Versus a Traditional Negative Pressure Wound Therapy System (tNPWT) in the Treatment of Lower Extremity Ulcers”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Other
    • Masking: None (Open Label)
  • Study Primary Completion Date: November 14, 2017

Detailed Description

The two types of NPWT systems include the tNPWT system that has successfully completed a coding verification request with CMS and has the following capabilities (e.g., range of negative pressure, connective tubing, canister, foam or gauze filler, and approved for home use), and a portable, canister-less, battery operated, disposable PICO system to see if there are any observed differences with regard to the clinical efficacy of the two devices.

Interventions

  • Device: PICO System
    • Negative Pressure Wound Therapy (NPWT) at 80mmHg (nominal) +/- 20 mmHg to the wound surface
  • Device: tNPWT System
    • NPWT from -25 mmHg and up to -200 mmHg; intensity settings of either low, medium and high; delivery modes of continuous or intermittent. The pressure, intensity and delivery settings will be left to the Investigator’s discretion at each study treatment visit.

Arms, Groups and Cohorts

  • Experimental: PICO System
    • Negative Pressure Wound Therapy (NPWT) at 80mmHg (nominal) +/- 20 mmHg to the wound surface
  • Active Comparator: tNPWT System
    • Traditional NPWT (tNPWT) from -25 mmHg and up to -200 mmHg; intensity settings of either low, medium and high; delivery modes of continuous or intermittent. The pressure, intensity and delivery settings will be left to the Investigator’s discretion at each study treatment visit.

Clinical Trial Outcome Measures

Primary Measures

  • Change in Ulcer Area From Baseline to the End of the Treatment Period
    • Time Frame: Baseline through 12 weeks
    • Ulcer area was photographed in order to determine the measurements of the post-debridement ulcer area (cm^2 and total percentage [%]) using the ARANZ Silhouette wound imaging and measurement device.
  • Percentage Change in Ulcer Area From Baseline to the End of the Treatment Period
    • Time Frame: Baseline through 12 weeks
    • Ulcer area was photographed in order to determine the measurements of the postdebridement ulcer area (cm^2 and total percentage [%]) using the ARANZ Silhouette wound imaging and measurement device.

Secondary Measures

  • Change in Target Ulcer Depth Following Treatment With Either PICO or tNPWT From Baseline Over the 12-week Treatment Period
    • Time Frame: Baseline through 12 weeks
    • Ulcer area was analyzed for depth measurement in millimeters (mm), volume measurement in cubic centimeters (cm^3), and percentage change (%) including terms for treatment, baseline depth, baseline volume, wound type, pooled sites, and wound duration using the ARANZ Silhouette wound imaging and measurement device.
  • Change in Target Ulcer Volume Following Treatment With Either PICO or tNPWT From Baseline Over the 12-week Treatment Period
    • Time Frame: Baseline through 12 weeks
    • Ulcer area was analyzed for depth measurement in millimeters (mm), volume measurement in cubic centimeters (cm^3), and percentage change (%) including terms for treatment, baseline depth, baseline volume, wound type, pooled sites, and wound duration using the ARANZ Silhouette wound imaging and measurement device.
  • Percentage Change in Target Ulcer Depth and Volume Following Treatment With Either PICO or tNPWT From Baseline Over the 12-week Treatment Period
    • Time Frame: Baseline through 12 weeks
    • Ulcer area was analyzed for depth measurement in millimeters (mm), volume measurement in cubic centimeters (cm^3), and percentage change (%) including terms for treatment, baseline depth, baseline volume, wound type, pooled sites, and wound duration using the ARANZ Silhouette wound imaging and measurement device.

Participating in This Clinical Trial

Inclusion Criteria

  • Provide informed consent
  • Age ≥ 18 years and of either sex
  • Willing to comply with protocol instructions, including allowing all study assessments
  • Have a Venous Leg Ulcer (VLU) between the knee and ankle (at or above the malleolus), with a surface area ≥ 2.0 cm2 and ≤ 36.0 cm2
  • Target ulcer duration ≥ 4 weeks but ≤ 104 weeks (24 months)
  • Have a Diabetic Foot Ulcer (DFU) present on any part of the plantar or dorsum surface of the foot, with a surface area ≥ 0.5 cm2 and ≤ 10.0 cm2
  • Target ulcer involves a full thickness skin loss, but WITHOUT exposure of tendon, muscle, or bone
  • Target ulcer duration ≥ 4 weeks but ≤ 52 weeks (12 months)
  • Acceptable state of health and nutrition

Exclusion Criteria

  • Therapy with another investigational agent within thirty (30) days of Screening, or during the study Ulcers which are deemed as highly exuding, per the Investigator's discretion.
  • Current diagnosis of osteomyelitis at the target wound location that is not currently receiving treatment [Documented history of resolved osteomyelitis is allowed].
  • Subjects with a VLU: Refusal of or inability to tolerate compression therapy.
  • Clinical evidence of target ulcer infection
  • Current systemic therapy with cytotoxic drugs.
  • Current therapy with chronic (> 10 days) oral corticosteroids.
  • Previous treatment with NPWT device or hyperbaric oxygen within 7 days of screening.
  • Malignancy in the target ulcer, or history of cancer in the preceding 5 years (other than carcinoma in situ of the cervix or adequately treated non-melanoma skin cancers)

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Smith & Nephew, Inc.
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Andy Weymann, MD, MBA, Study Chair, Smith & Nephew, Inc.

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