Pilot Study Comparing Negative Pressure Dressings to Conventional Dressings

Venous Leg Ulcer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03450616
• Other study ID #: 17-0951
• Status: Withdrawn
• Phase: N/A
• Start date: June 2019
• Est. completion date: December 2019

Study information

• Verified date: May 2019
• Source: Northwell Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 2019
• Est. primary completion date: December 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Leg Ulcer
• Varicose Ulcer
• Venous Leg Ulcer

Intervention

Device:
• PICO Negative Pressure Wound Therapy
Negative Pressure Wound Therapy Device

Procedure:
• Compression Dressing
Standard of Care Compression Dressing

Locations

Country	Name	City	State
United States	Staten Island University Hospital	Staten Island	New York

Sponsors (1)

Lead Sponsor	Collaborator
Northwell Health

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of healing	Surface area and depth of wound measurements will be collected to determine rate of healing	Weekly for three weeks