NCT00000431

Brief Summary

Most chronic (long-lasting) wounds of the leg (also known as venous ulcers) fail to heal in a reasonable period of time. Although researchers have made great progress in understanding how the body repairs wounds, attempts to develop new treatments have been disappointing. In general, treatments based on recent findings about the details of wound repair have not greatly reduced the number of people who have chronic wounds. The long-term goal of this study is to evaluate a new approach for healing a chronic wound. Current methods of directly applying substances that are involved in wound healing to a chronic wound do not cause enough healing. PDGF-B (platelet-derived growth factor B), a factor associated with wound healing, might dramatically enhance healing if a genetically engineered virus is injected into the wound that causes cells in the wound to produce PDGF-B in large quantities.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Jan 2005

Longer than P75 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 18, 2000

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 19, 2000

Completed
5 years until next milestone

Study Start

First participant enrolled

January 1, 2005

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2008

Completed
2.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2011

Completed
Last Updated

May 13, 2013

Status Verified

March 1, 2009

Enrollment Period

3.5 years

First QC Date

January 18, 2000

Last Update Submit

May 8, 2013

Conditions

Varicose Ulcer

Keywords

Venous leg ulcerWound healingSomatic gene therapyPDGF-B

Outcome Measures

Primary Outcomes (1)

  • Safety of treatment

    Wtihin 28 days of administration

Secondary Outcomes (1)

  • Proof of concept

    Within 28 days of administration

Study Arms (1)

1

EXPERIMENTAL

Upon evaluation, participant will be treated with a single intra-ulcer injection of PDGF-B/Ad5 in the wound. Patients will receive only one dose, which will be administered during a 72-hour inpatient stay in a research unit at the Hospital of the University of Pennsylvania. This study will use a standard three-six dose-escalation scheme.

Drug: PDGF-B/Ad5

Interventions

PDGF-B/Ad5DRUG

This is a dose finding study to evaluate the safety of a single injection of PDGF dna in an adenoviral vector.

1

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patient must have a venous leg ulcer.
  • Patient must have failed at least 6 weeks of limb compression.
  • Wound must be free of necrotic debris.
  • Wound must be greater than 5 cm2 and less than 20 cm2.
  • Wound must be more than 6 months old.
  • Affected limb must have an ankle-brachial index (ABI) \> 0.85.
  • Patient must be more than 18 years old.

You may not qualify if:

  • Any active cancer or cancer in remission for less than 10 years.
  • Patients with life expectancy of less than 6 months.
  • Liver function tests (Alanine Transaminase(ALT) Aspartate Amino Transfer (AST) Alkaline Phosphatase (ALK PHOS) and bilirubin) greater than 1.5x upper limit of normal for the reference lab.
  • Patients with intercurrent organ damage or medical problems.
  • Pregnant or lactating females.
  • Any requirement for systemic corticosteroids or immunosuppressives, or history of corticosteroid or immunosuppressive use in the 4 weeks previous to study entry.
  • Seropositive for hepatitis B surface antigen or hepatitis C antibody.
  • Any concurrent medical illness that may be exacerbated by PDGF-B/Ad5 administration.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

MeSH Terms

Conditions

Varicose Ulcer

Condition Hierarchy (Ancestors)

Varicose VeinsVascular DiseasesCardiovascular DiseasesLeg UlcerSkin UlcerSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • David J. Margolis, MD

    University of Pennsylvania

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 18, 2000

First Posted

January 19, 2000

Study Start

January 1, 2005

Primary Completion

July 1, 2008

Study Completion

March 1, 2011

Last Updated

May 13, 2013

Record last verified: 2009-03

Locations

US(1)