Pilot Study Comparing Negative Pressure Dressings to Conv... | NCT03450616

Studies
Pilot Study Comparing Negative Pressure Dressings to Conventional Dressings

NCT03450616

Sponsor

Northwell Health

Status

Withdrawn

Last Update Posted

May 29, 2019Actual

Enrollment

0Actual

Phase

Not Applicable

Conditions

Venous Leg Ulcer

Interventions

PICO Negative Pressure Wound Therapy
Compression Dressing

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2019

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Unable to begin study due to funding. PI has left organization

Expanded Access Info

Start Date

Jun 2019Estimated

Primary Completion Date

Dec 2019Estimated

Completion Date

Dec 2019Estimated

First Submitted Date

Feb 23, 2018

First Submission Date that Met QC Criteria

Feb 23, 2018

First Posted Date

Mar 1, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 24, 2019

Last Update Posted Date

May 29, 2019Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Yes

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Negative Pressure Wound Therapy	Experimental	Subjects will have one venous stasis ulcer treated with the PICO Negative Pressure Wound Therapy Device	Device: PICO Negative Pressure Wound Therapy
Compression Dressing- Standard of Care	Active Comparator	Subjects will have one venous stasis ulcer treated with the standard of care compression dressing.	Procedure: Compression Dressing

Interventions

Name	Type	Description	Arm Group Labels	Other Names
PICO Negative Pressure Wound Therapy	Device	Negative Pressure Wound Therapy Device	Negative Pressure Wound Therapy

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Facility	Status	City	State	ZIP	Country	Contacts
Staten Island University Hospital		Staten Island	New York	10305	United States

IPD Sharing Statement Module

Plan to Share IPD

Description

Data will not be made available to other researchers.

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

ID	Term
D014648	Varicose Veins
D014652	Vascular Diseases
D002318	Cardiovascular Diseases
D007871	Leg Ulcer