Pilot Study Comparing Negative Pressure Dressings to Conventional Dressings

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2019-06-30

Study Completion Date

2019-12-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Venous Leg Ulcer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Caregivers

Subjects and treating physician will be blinded to treatment.

Study Groups

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Negative Pressure Wound Therapy

Subjects will have one venous stasis ulcer treated with the PICO Negative Pressure Wound Therapy Device

Group Type EXPERIMENTAL

PICO Negative Pressure Wound Therapy

Intervention Type DEVICE

Negative Pressure Wound Therapy Device

Compression Dressing- Standard of Care

Subjects will have one venous stasis ulcer treated with the standard of care compression dressing.

Group Type ACTIVE_COMPARATOR

Compression Dressing

Intervention Type PROCEDURE

Standard of Care Compression Dressing

Interventions

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PICO Negative Pressure Wound Therapy

Negative Pressure Wound Therapy Device

Intervention Type DEVICE

Compression Dressing

Standard of Care Compression Dressing

Intervention Type PROCEDURE

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No