The main purpose of the study is to compare treatment of non-infected venous leg ulcers using ICXP007 combined with four-layer compression bandaging, placebo combined with four-layer compression bandaging and four-layer compression bandaging alone.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
396
Incidence of 100% closure (epithelialized) at any time during the initial 12 weeks of the treatment period.
Time frame: 12 weeks
Overall rate of wound area reduction during treatment.
Time to first closure.
Incidence of closure at 16, 20 and 24 weeks.
Incidence of reopening at up to 16, 20 and 24 weeks.
Incidence of re-closure at 16, 20 and 24 weeks.
Qualitative levels of wound pain.
Percentage of Day 0 wound surface area.
Percentage reduction in wound surface area from previous visit.
Percentage reduction in wound surface area from Day 0.
Appearance of new ulcer in the target wound area post closure.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Institute for Advanced Wound Care
Montgomery, Alabama, United States
TERMINATEDHOPE Research Institute
Phoenix, Arizona, United States
RECRUITINGSouthern Arizona VA Health Care System
Tucson, Arizona, United States
RECRUITINGAlameda County Medical Center
Alameda, California, United States
WITHDRAWNManzainto Medical Clinic
Carmichael, California, United States
RECRUITINGBay Area Foot Care
Castro Valley, California, United States
ACTIVE_NOT_RECRUITINGM Limova, MD
Fresno, California, United States
ACTIVE_NOT_RECRUITINGVA Medical Center
Sacramento, California, United States
ACTIVE_NOT_RECRUITINGBay Area Foot care
San Francisco, California, United States
ACTIVE_NOT_RECRUITINGUniversity of Florida, Department of Surgery
Gainesville, Florida, United States
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