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

Venous Leg Ulcer Clinical Trial

Official title:

TRIAL OF COMPASSIONATE USE OF HP802-247 TO TREAT VENOUS LEG ULCERS IN SUBJECTS WHO HAVE FAILED MULTIPLE OTHER HEALING TECHNOLOGIES

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01320605
• Other study ID #: E001
• Status: Recruiting
• Phase: Phase 2
• First received: March 21, 2011
• Last updated: March 21, 2011
• Start date: March 2011
• Est. completion date: June 2012

Study information

• Verified date: March 2011
• Source: Atlantic Health System
• Contact: David E Eisenbud, MD
• Phone: (908) 522-5900
• Email: David.Eisenbud[@]Atlantichealth.org
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 5
• Est. completion date: June 2012
• Est. primary completion date: June 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Leg Ulcer
• Ulcer
• Varicose Ulcer
• Venous Leg Ulcer

Intervention

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

Locations

Country	Name	City	State
United States	Overlook Hospital Wound Healing Program	Summit	New Jersey

Sponsors (1)

Lead Sponsor	Collaborator
Atlantic Health System

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of complete wound closure during the treatment period		24 weeks	No