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

March 21, 2011
March 21, 2011
March 2011
June 2012   (final data collection date for primary outcome measure)
Incidence of complete wound closure during the treatment period [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
Same as current
No Changes Posted
Not Provided
Not Provided
Not Provided
Not Provided
 
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.

Not Provided
Interventional
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Venous Leg Ulcer
Biological: Weekly wound spray with components 1 and 2 of the compound HP802-247
Weekly spray with HP802-247
Experimental: Weekly HP802247 treatment
Intervention: Biological: Weekly wound spray with components 1 and 2 of the compound HP802-247
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
5
June 2012
June 2012   (final data collection date for primary outcome measure)

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
Both
Not Provided
No
Contact: David E Eisenbud, MD (908) 522-5900 David.Eisenbud@Atlantichealth.org
United States
 
NCT01320605
E001
No
David Eisenbud, MD, Overlook Hospital Wound Healing Program
Atlantic Health System
Not Provided
Not Provided
Atlantic Health System
March 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP