Recruiting
Phase 2

hp802-247

Sponsor:

Atlantic Health System

Code:

NCT01320605

Conditions

Venous Leg Ulcer

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

Interventions

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

Study Details

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.

Conditions

Venous Leg Ulcer

Study ID

NCT01320605

Start date

Mar, 2011

Status verified date

Mar, 2011

Completion date

Jun, 2012

Anticipated

Primary completion date

Jun, 2012

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

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 Design

Enrollment

5 participants

Anticipated

Allocation

Non randomized

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Weekly HP802247 treatment

Interventions

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

Weekly spray with HP802-247

Primary outcome measure

  • Incidence of complete wound closure during the treatment period [ Time Frame: 24 weeks ]

Central Contacts and Locations

Central contacts

David E Eisenbud, MD

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

Locations

Overlook Hospital Wound Healing Program

Recruiting

Summit, New Jersey, United States, 07901

Contacts

Concetta Lamore, RN

908-522-5900Concetta.Lamore@AtlanticHealth.org

More Information

Sponsor

Atlantic Health System

Last update posted

Mar 22, 2011

Last verified

Mar, 2011

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Atlantic Health System on 2011-03-22.