Back to resultsPilot Study Comparing Negative Pressure Dressings to Conventional Dressings
Primary Purpose
Venous Leg Ulcer
Status
Withdrawn
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
PICO Negative Pressure Wound Therapy
Compression Dressing
Sponsored by
About this trial
This is an interventional treatment trial for Venous Leg Ulcer
Eligibility Criteria
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.
Sites / Locations
- Staten Island University Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Negative Pressure Wound Therapy
Compression Dressing- Standard of Care
Arm Description
Subjects will have one venous stasis ulcer treated with the PICO Negative Pressure Wound Therapy Device
Subjects will have one venous stasis ulcer treated with the standard of care compression dressing.
Outcomes
Primary Outcome Measures
Rate of healing
Surface area and depth of wound measurements will be collected to determine rate of healing
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03450616
Brief Title
Pilot Study Comparing Negative Pressure Dressings to Conventional Dressings
Official Title
Pilot Study Comparing Negative Pressure Dressings to Conventional Dressings for the Management of Patients With Venous Stasis Ulcers.
Study Type
Interventional
2. Study Status
Record Verification Date
May 2019
Overall Recruitment Status
Withdrawn
Why Stopped
Unable to begin study due to funding. PI has left organization
Study Start Date
June 2019 (Anticipated)
Primary Completion Date
December 2019 (Anticipated)
Study Completion Date
December 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Northwell Health
4. Oversight
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
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Venous Leg Ulcer
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
All subjects will receive both treatment arms at the same time.
Masking
ParticipantCare Provider
Masking Description
Subjects and treating physician will be blinded to treatment.
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Negative Pressure Wound Therapy
Arm Type
Experimental
Arm Description
Subjects will have one venous stasis ulcer treated with the PICO Negative Pressure Wound Therapy Device
Arm Title
Compression Dressing- Standard of Care
Arm Type
Active Comparator
Arm Description
Subjects will have one venous stasis ulcer treated with the standard of care compression dressing.
Intervention Type
Device
Intervention Name(s)
PICO Negative Pressure Wound Therapy
Intervention Description
Negative Pressure Wound Therapy Device
Intervention Type
Procedure
Intervention Name(s)
Compression Dressing
Intervention Description
Standard of Care Compression Dressing
Primary Outcome Measure Information:
Title
Rate of healing
Description
Surface area and depth of wound measurements will be collected to determine rate of healing
Time Frame
Weekly for three weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Staten Island University Hospital
City
Staten Island
State/Province
New York
ZIP/Postal Code
10305
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
Data will not be made available to other researchers.
Learn more about this trial
Pilot Study Comparing Negative Pressure Dressings to Conventional Dressings
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