Trial of Compassionate Use of hp802-247 to Treat Venous Leg Ulcers in Subjects Who Have Failed Multiple Other Healing Technologies
TRIAL OF COMPASSIONATE USE OF HP802-247 TO TREAT VENOUS LEG ULCERS IN SUBJECTS WHO HAVE FAILED MULTIPLE OTHER HEALING TECHNOLOGIES
1 other identifier
interventional
5
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2
Started Mar 2011
Shorter than P25 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2011
CompletedFirst Submitted
Initial submission to the registry
March 21, 2011
CompletedFirst Posted
Study publicly available on registry
March 22, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2012
CompletedMarch 22, 2011
March 1, 2011
1.3 years
March 21, 2011
March 21, 2011
Conditions
Outcome Measures
Primary Outcomes (1)
Incidence of complete wound closure during the treatment period
24 weeks
Study Arms (1)
Weekly HP802247 treatment
EXPERIMENTALInterventions
Weekly spray with HP802-247
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Overlook Hospital Wound Healing Program
Summit, New Jersey, 07901, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
March 21, 2011
First Posted
March 22, 2011
Study Start
March 1, 2011
Primary Completion
June 1, 2012
Study Completion
June 1, 2012
Last Updated
March 22, 2011
Record last verified: 2011-03