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Preliminary Testing of New Treatment for Chronic Leg Wounds

NCT01858272 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2017-01-11

No results posted yet for this study

Summary

The primary objectives of this study are to evaluate the efficacy, dosing, and safety of an intra-ulcer injection H5.020CMV.PDGF-b in adults who have a venous leg ulcer. The primary endpoint of this Phase I trial is the determination of the Maximum Tolerated Dose (MTD) for the intra-ulcer injection of H5.020CMV.PDGF-b.

Conditions

  • Venous Ulcer

Interventions

DRUG

H5.020CMV.PDGF-b and limb compression bandage

Sponsors & Collaborators

Principal Investigators

  • David J. Margolis, MD, PhD · University of Pennsylvania

Study Design

Allocation
NA
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2004-09-30
Primary Completion
2008-08-31
Completion
2009-06-30

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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 NCT01858272 on ClinicalTrials.gov