Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 3:11 AM
Ignite Modification Date:
2025-12-25 @ 3:11 AM
NCT ID:
NCT01320605
Eligibility Criteria:
Inclusion Criteria:
* Chronic (duration greater than six months) open wound that has been diagnosed as a venous leg ulcer on the basis of consultation with a vascular surgeon and/or venous ultrasound evaluation
* Patient has been under continuous care at the Overlook Hospital Wound Healing Program for at least four months for treatment of the study lesion(s)
* Total study wound surface area greater than or equal to 12 cm2, but less than 48 cm2
* Wounds must have failed to heal despite the patient's compliance with elevation, compression and regular debridement, as well as at least one advanced wound therapy (for example, bioengineered dressing such as Oasis® or MatriStem®, low-frequency ultrasound, or cultured skin substitute (Apligraf®, Dermagraft®)
* Patient has no reasonable likelihood of healing with additional attempts to treat with FDA-approved products and treatments
Exclusion Criteria:
* Patients eligible to participate in a Healthpoint sponsored clinical study of HP802-247 trial (IND 13,900)
* Patients who have been previously treated with HP802-247
* Women of child-bearing potential
* Patients who are allergic to any of the components of HP802-247
Healthy Volunteers:
False
Sex:
ALL
Study:
NCT01320605
Study Brief:
Protocol Section:
NCT01320605