Pilot Study Comparing Negative Pressure Dressings to Conventional Dressings
Withdrawn before enrolling · Not applicable
Conditions studied: Venous Leg Ulcer
In brief
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.
Key facts
- Study ID
- NCT03450616
- Run by
- Northwell Health
- People needed
- 0
- Starts
- 2019-06-01
- Expected to finish
- 2019-12-01
- Last updated by the study team
- 2019-05-29
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
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.
- 18 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.
Where it is running
- Staten Island University Hospital — Staten Island, New York, United States
Full record on ClinicalTrials.gov
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