Primary Investigator:
Sandra Tidwell. ARNP

Description:
This is a 16-week study for subjects with a venous leg ulcer between the knee and ankle. This research is being done to determine the wound healing effectiveness of two dosing frequencies and two concentrations of a cell-based study spray, together with standard care, compared to placebo, plus standard care. The primary outcome measures the percent of change from baseline in the target wound area

Eligibility:

• Have a venous leg ulcer between the knee and ankle, at or above the malleolus.
• Venous insufficiency confirmed by ultrasound examination for valvular or venous incompetence.
• Target ulcer duration greater than or equal to 6 weeks but less than or equal to 24 months. 
• Other eligibility criteria may apply. Please contact study coordinator.

Exclusions:

• A leg ulcer caused by non-venous conditions, such as: sickle cell anemia.
• Inability to tolerate therapy with compression wraps.
• Women who are pregnant or lactating.
•  Other exclusion criteria may apply. Please contact study coordinator.

Study Timeline:
Closed to Enrollment

Study Contact:

Claudia Flores RN CCRC Claudia.Flores@providence.org
509-4744306

Study Sponsor:
Healthpoint