Venous Leg Ulcer
Conditions
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.
Interventions
Negative Pressure Wound Therapy Device
PROCEDURECompression Dressing
Standard of Care Compression Dressing
Sponsors
Northwell Health
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Caregiver)
Masking description
Subjects and treating physician will be blinded to treatment.
Intervention model description
All subjects will receive both treatment arms at the same time.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Rate of healing | Weekly for three weeks | Surface area and depth of wound measurements will be collected to determine rate of healing |
Countries
United States
Outcome results
None listed