Pilot Study Comparing Negative Pressure Dressings to Conventional Dressings

Study Overview
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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.

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.

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

Conditions
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Venous Leg Ulcer

Intervention / Treatment
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* Device: PICO Negative Pressure Wound Therapy
* Procedure: Compression Dressing


Participation Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: All subjects will receive both treatment arms at the same time.
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Negative Pressure Wound Therapy<br>Subjects will have one venous stasis ulcer treated with the PICO Negative Pressure Wound Therapy Device | Device: PICO Negative Pressure Wound Therapy<br>* Negative Pressure Wound Therapy Device<br>|
| Active Comparator: Compression Dressing- Standard of Care<br>Subjects will have one venous stasis ulcer treated with the standard of care compression dressing. | Procedure: Compression Dressing<br>* Standard of Care Compression Dressing<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 |