Back to resultsTrial of Compassionate Use of hp802-247 to Treat Venous Leg Ulcers in Subjects Who Have Failed Multiple Other Healing Technologies
Primary Purpose
Venous Leg Ulcer
Status
Unknown status
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Weekly wound spray with components 1 and 2 of the compound HP802-247
Sponsored by
About this trial
This is an interventional treatment trial for Venous Leg Ulcer
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
Sites / Locations
- Overlook Hospital Wound Healing ProgramRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Weekly HP802247 treatment
Arm Description
Outcomes
Primary Outcome Measures
Incidence of complete wound closure during the treatment period
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01320605
Brief Title
Trial of Compassionate Use of hp802-247 to Treat Venous Leg Ulcers in Subjects Who Have Failed Multiple Other Healing Technologies
Official Title
TRIAL OF COMPASSIONATE USE OF HP802-247 TO TREAT VENOUS LEG ULCERS IN SUBJECTS WHO HAVE FAILED MULTIPLE OTHER HEALING TECHNOLOGIES
Study Type
Interventional
2. Study Status
Record Verification Date
March 2011
Overall Recruitment Status
Unknown status
Study Start Date
March 2011 (undefined)
Primary Completion Date
June 2012 (Anticipated)
Study Completion Date
June 2012 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
Atlantic Health System
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Venous Leg Ulcer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
5 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Weekly HP802247 treatment
Arm Type
Experimental
Intervention Type
Biological
Intervention Name(s)
Weekly wound spray with components 1 and 2 of the compound HP802-247
Intervention Description
Weekly spray with HP802-247
Primary Outcome Measure Information:
Title
Incidence of complete wound closure during the treatment period
Time Frame
24 weeks
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
David E Eisenbud, MD
Phone
(908) 522-5900
Email
David.Eisenbud@Atlantichealth.org
Facility Information:
Facility Name
Overlook Hospital Wound Healing Program
City
Summit
State/Province
New Jersey
ZIP/Postal Code
07901
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Concetta Lamore, RN
Phone
908-522-5900
Email
Concetta.Lamore@AtlanticHealth.org
12. IPD Sharing Statement
Learn more about this trial
Trial of Compassionate Use of hp802-247 to Treat Venous Leg Ulcers in Subjects Who Have Failed Multiple Other Healing Technologies
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