Pilot Study Comparing Negative Pressure Dressings to Conventional Dressings

NCT03450616 | Withdrawn FDA Device

• 1 other identifier: 17-0951
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Venous Leg Ulcer

Outcome Measures

Primary Outcomes (1)

• Rate of healing

  Surface area and depth of wound measurements will be collected to determine rate of healing

  Weekly for three weeks

Study Arms (2)

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

PICO Negative Pressure Wound Therapy DEVICE

Negative Pressure Wound Therapy Device

Negative Pressure Wound Therapy

Compression Dressing PROCEDURE

Standard of Care Compression Dressing

Compression Dressing- Standard of Care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• years old or older
• Have an ankle brachial pressure index of at least 0.8 that was measured within the previous 3 months.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Northwell Health: lead

Study Sites (1)

Staten Island University Hospital

Staten Island, New York, 10305, United States

Location

MeSH Terms

Conditions

Varicose Ulcer

Condition Hierarchy (Ancestors)

Varicose Veins; Vascular Diseases; Cardiovascular Diseases; Leg Ulcer; Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Masking Details: Subjects and treating physician will be blinded to treatment.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: All subjects will receive both treatment arms at the same time.

Study Record Dates

• First Submitted: February 23, 2018
• First Posted: March 1, 2018
• Study Start: June 1, 2019
• Primary Completion: December 1, 2019
• Study Completion: December 1, 2019
• Last Updated: May 29, 2019

Record last verified: 2019-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)