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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2011 by Atlantic Health System.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Atlantic Health System
ClinicalTrials.gov Identifier:
NCT01320605
First received: March 21, 2011
Last updated: NA
Last verified: March 2011
History: No changes posted
  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.


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

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: TRIAL OF COMPASSIONATE USE OF HP802-247 TO TREAT VENOUS LEG ULCERS IN SUBJECTS WHO HAVE FAILED MULTIPLE OTHER HEALING TECHNOLOGIES

Resource links provided by NLM:


Further study details as provided by Atlantic Health System:

Primary Outcome Measures:
  • Incidence of complete wound closure during the treatment period [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 5
Study Start Date: March 2011
Estimated Study Completion Date: June 2012
Estimated Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Weekly HP802247 treatment Biological: Weekly wound spray with components 1 and 2 of the compound HP802-247
Weekly spray with HP802-247

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01320605

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

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

No publications provided

Responsible Party: David Eisenbud, MD, Overlook Hospital Wound Healing Program
ClinicalTrials.gov Identifier: NCT01320605     History of Changes
Other Study ID Numbers: E001
Study First Received: March 21, 2011
Last Updated: March 21, 2011
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on November 25, 2014