Trial of Compassionate Use of hp802-247 to Treat Venous Leg Ulcers in Subjects Who Have Failed Multiple Other Healing Technologies
| Status: | Completed |
|---|---|
| Conditions: | Other Indications, Cardiology, Gastrointestinal |
| Therapuetic Areas: | Cardiology / Vascular Diseases, Gastroenterology, Other |
| Healthy: | No |
| Age Range: | Any |
| Updated: | 4/2/2016 |
| Start Date: | March 2011 |
| End Date: | June 2012 |
| Contact: | David E Eisenbud, MD |
| Email: | David.Eisenbud@Atlantichealth.org |
| Phone: | (908) 522-5900 |
TRIAL OF COMPASSIONATE USE OF HP802-247 TO TREAT VENOUS LEG ULCERS IN SUBJECTS WHO HAVE FAILED MULTIPLE OTHER HEALING TECHNOLOGIES
Compound HP802-247 comprises two topical sprays, administered sequentially right after
another; these deliver a suspension of fibroblasts and keratinocytes to the wound surface.
HP802-247 is the subject of a larger Phase 2 multi-center trial for treating venous leg
ulcers. The present study will enroll up to five patients who are suffering venous leg
ulcers, have failed a prolonged course of standard wound therapy and one or more advanced
technologies, but who would not qualify for the Phase 2 study.
another; these deliver a suspension of fibroblasts and keratinocytes to the wound surface.
HP802-247 is the subject of a larger Phase 2 multi-center trial for treating venous leg
ulcers. The present study will enroll up to five patients who are suffering venous leg
ulcers, have failed a prolonged course of standard wound therapy and one or more advanced
technologies, but who would not qualify for the Phase 2 study.
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
We found this trial at
1
site
Click here to add this to my saved trials
