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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

NCT01320605 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 5

Last updated 2011-03-22

No results posted yet for this study

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

Interventions

BIOLOGICAL

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

Weekly spray with HP802-247

Sponsors & Collaborators

  • Atlantic Health System

    lead OTHER

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-03-31
Primary Completion
2012-06-30
Completion
2012-06-30

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01320605 on ClinicalTrials.gov