Summit, New Jersey 07901

  • Venous Leg Ulcer

Purpose:

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.


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


Study is Available At:


Original ID:

E001


NCT ID:

NCT01320605


Secondary ID:


Study Acronym:


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


Overall Status:

Recruiting


Study Phase:

Phase 2


Genders:

Both


Minimum Age:

N/A


Maximum Age:

N/A


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Atlantic Health System


Oversight Authority:

United States: Food and Drug Administration


Reasons Why Stopped:


Study Type:

Interventional


Study Design:

Allocation: Non-Randomized, Endpoint Classificati


Number of Arms:

1


Number of Groups:

0


Total Enrollment:

5


Enrollment Type:

Anticipated


Overall Contact Information

Primary Contact:David E Eisenbud, MD
(908) 522-5900
David.Eisenbud@Atlantichealth.org

Study Dates

Start Date:March 2011
Completion Date:June 2012
Completion Type:Anticipated
Primary Completion Date:June 2012
Primary Completion Type:Anticipated
Verification Date:March 2011
Last Changed Date:March 21, 2011
First Received Date:March 21, 2011

Study Outcomes

Outcome Type:Primary Outcome
Measure:Incidence of complete wound closure during the treatment period
Time Frame:24 weeks
Safety Issues:False

Study Interventions

Intervention Type:Biological
Name:Weekly wound spray with components 1 and 2 of the
Description:Weekly spray with HP802-247
Arm Name:Weekly HP802247 treatment

Study Arms

Study Arm Type:Experimental
Arm Name:Weekly HP802247 treatment

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:Atlantic Health System

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: February 02, 2023

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