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

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.

Study Overview

• Status: Unknown
• Conditions: Venous Leg Ulcer
• Intervention / Treatment: Biological: Weekly wound spray with components 1 and 2 of the compound HP802-247

• Study Type: Interventional
• Enrollment (Anticipated): 5
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • New Jersey
    • Summit, New Jersey, United States, 07901
      • Recruiting
      • Overlook Hospital Wound Healing Program
      • Contact: Concetta Lamore, RN; Phone Number: 908-522-5900; Email: Concetta.Lamore@AtlanticHealth.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Weekly HP802247 treatment	Biological: Weekly wound spray with components 1 and 2 of the compound HP802-247; Weekly spray with HP802-247

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Atlantic Health System

Study record dates

Study Major Dates

• Study Start: March 1, 2011
• Primary Completion (Anticipated): June 1, 2012
• Study Completion (Anticipated): June 1, 2012

Study Registration Dates

• First Submitted: March 21, 2011
• First Submitted That Met QC Criteria: March 21, 2011
• First Posted (Estimate): March 22, 2011

Study Record Updates

• Last Update Posted (Estimate): March 22, 2011
• Last Update Submitted That Met QC Criteria: March 21, 2011
• Last Verified: March 1, 2011

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Skin Diseases; Skin Ulcer; Varicose Veins; Ulcer; Leg Ulcer; Varicose Ulcer
• Other Study ID Numbers: E001