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

Status

UNKNOWN

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01320605

Enrollment

Registered

2011-03-22

Start date

2011-03-31

Completion date

2012-06-30

Last updated

2011-03-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Venous Leg Ulcer

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.

Interventions

BIOLOGICALWeekly wound spray with components 1 and 2 of the compound HP802-247

Weekly spray with HP802-247

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Incidence of complete wound closure during the treatment period	24 weeks

Countries

United States

Contacts

Primary ContactDavid E Eisenbud, MD

David.Eisenbud@Atlantichealth.org(908) 522-5900

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026