Pilot Study Comparing Negative Pressure Dressings to Conventional Dressings

Pilot Study Comparing Negative Pressure Dressings to Conventional Dressings for the Management of Patients With Venous Stasis Ulcers.

This study is being conducted to determine how the PICO™ Negative Pressure Wound Therapy compares to standard care treatment for venous stasis ulcers, as there is no evidence to date.

Study Overview

• Status: Withdrawn
• Conditions: Venous Leg Ulcer
• Intervention / Treatment: Device: PICO Negative Pressure Wound Therapy; Procedure: Compression Dressing

Detailed Description

This is a single-blind, randomized pilot study conducted in patients with bilateral venous stasis leg ulcers.

The aim of the study is to compare the rate of healing for venous stasis ulcers when using the PICO™ single use Negative pressure wound therapy (NPWT) system versus standard care.

The primary objective is to determine if the PICO™ NPWT system results in an increased rate of healing when compared to standard of care for the treatment of venous stasis ulcers.

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • Staten Island, New York, United States, 10305
      • Staten Island University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Patient with bilateral venous leg ulcers (one on each lower extremity) (defined as any break in the skin that has either been present for longer than 6 wks or occurred in a person with a history of venous leg ulceration).
• The ulcer is required to be venous in appearance (ie: moist, shallow, and of an irregular shape), and judged unlikely to heal within 21 days.
• 18 years old or older
• Have an ankle brachial pressure index of at least 0.8 that was measured within the previous 3 months.

Exclusion Criteria:

• • Patients on anticoagulants- (ie: warfarin, direct thrombin inhibitors).

  • Patients who have a pressure index measured within the previous 3 months to be greater than 1.20
  • Patients with venous stasis ulcers greater than 17cm by 17cm.
  • Gross leg edema
  • Severe wound exudate
  • Patients with malignancy in the wound bed or margins of the wound
  • Previously confirmed and untreated osteomyelitis.
  • Patients with necrotic tissue with eschar present.
  • Patients with wounds that involve exposed arteries, veins, nerves, bone fragments or sharp edges.
  • Patients with wounds that requires surgical suction.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Negative Pressure Wound Therapy; Subjects will have one venous stasis ulcer treated with the PICO Negative Pressure Wound Therapy Device	Device: PICO Negative Pressure Wound Therapy; Negative Pressure Wound Therapy Device
ACTIVE_COMPARATOR: Compression Dressing- Standard of Care; Subjects will have one venous stasis ulcer treated with the standard of care compression dressing.	Procedure: Compression Dressing; Standard of Care Compression Dressing

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of healing	Surface area and depth of wound measurements will be collected to determine rate of healing	Weekly for three weeks

Collaborators and Investigators

• Sponsor: Northwell Health

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): June 1, 2019
• Primary Completion (ANTICIPATED): December 1, 2019
• Study Completion (ANTICIPATED): December 1, 2019

Study Registration Dates

• First Submitted: February 23, 2018
• First Submitted That Met QC Criteria: February 23, 2018
• First Posted (ACTUAL): March 1, 2018

Study Record Updates

• Last Update Posted (ACTUAL): May 29, 2019
• Last Update Submitted That Met QC Criteria: May 24, 2019
• Last Verified: May 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Skin Diseases; Skin Ulcer; Varicose Veins; Leg Ulcer; Varicose Ulcer
• Other Study ID Numbers: 17-0951

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Data will not be made available to other researchers.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No