Pilot Study Comparing Negative Pressure Dressings to Conventional Dressings for the Management of Patients With Venous Stasis Ulcers.
Trial Snapshot
- Phase
- Not Applicable
- Status
- Withdrawn
- Sponsor
- Northwell Health
- Locations
- 1
- Primary Endpoint
- Rate of healing
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Care Provider)
Masking Description
Subjects and treating physician will be blinded to treatment.
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
Negative Pressure Wound Therapy
Subjects will have one venous stasis ulcer treated with the PICO Negative Pressure Wound Therapy Device
Intervention: PICO 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.
Intervention: Compression Dressing (Procedure)
Outcomes
Primary Outcomes
Rate of healing
Time Frame: Weekly for three weeks
Surface area and depth of wound measurements will be collected to determine rate of healing
Secondary Outcomes
No secondary outcomes reported