Trial of Compassionate Use of hp802-247 to Treat Venous Leg Ulcers in Subjects Who Have Failed Multiple Other Healing Technologies

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01320605
Recruitment Status : Unknown
Verified March 2011 by Atlantic Health System.
Recruitment status was:  Recruiting
First Posted : March 22, 2011
Last Update Posted : March 22, 2011
Information provided by:
Atlantic Health System

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.

Condition or disease Intervention/treatment Phase
Venous Leg Ulcer Biological: Weekly wound spray with components 1 and 2 of the compound HP802-247 Phase 2

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 5 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Study Start Date : March 2011
Estimated Primary Completion Date : June 2012
Estimated Study Completion Date : June 2012

Resource links provided by the National Library of Medicine

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

Primary Outcome Measures :
  1. Incidence of complete wound closure during the treatment period [ Time Frame: 24 weeks ]

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01320605

Contact: David E Eisenbud, MD (908) 522-5900

United States, New Jersey
Overlook Hospital Wound Healing Program Recruiting
Summit, New Jersey, United States, 07901
Contact: Concetta Lamore, RN    908-522-5900   
Sponsors and Collaborators
Atlantic Health System

Responsible Party: David Eisenbud, MD, Overlook Hospital Wound Healing Program Identifier: NCT01320605     History of Changes
Other Study ID Numbers: E001
First Posted: March 22, 2011    Key Record Dates
Last Update Posted: March 22, 2011
Last Verified: March 2011

Additional relevant MeSH terms:
Leg Ulcer
Varicose Ulcer
Pathologic Processes
Skin Ulcer
Skin Diseases
Varicose Veins
Vascular Diseases
Cardiovascular Diseases