NCT00270972

Brief Summary

This study was designed to confirm the clinical benefits and safety of OrCel in the treatment of venous ulcers. OrCel and standard care are compared to standard care alone. Standard care consists of currently accepted compression therapy. Patients are treated for 12 weeks. Patients with healed ulcers are followed for an additional 12 weeks to assess durability of the healed wound.

Trial Health

55
Monitor

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Geographic Reach
1 country

10 active sites

Status
unknown

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

Study Start

First participant enrolled

September 1, 2005

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

December 28, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 29, 2005

Completed
Last Updated

June 5, 2006

Status Verified

June 1, 2006

First QC Date

December 28, 2005

Last Update Submit

June 2, 2006

Conditions

Venous InsufficiencyLeg Ulcer

Keywords

Venous leg ulcerVenous insufficiencyOrCel

Outcome Measures

Primary Outcomes (1)

  • Investigator Assessment of wound healing

Secondary Outcomes (2)

  • Planimetric assessment of wound healing

  • Photographic assessment of wound healing

Interventions

Bilayered Cellular Matrix (OrCel)DEVICE

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Any race, between 18 and 85 years of age
  • Male or female
  • Chronic venous insufficiency
  • Ulcer size between 2 and 20 sq cm, inclusive
  • Ulcer present for at least one month
  • ABI \>0.7

You may not qualify if:

  • Decrease in wound size \>35% during Screening Phase
  • Infection at ulcer site
  • Uncontrolled diabetes mellitus
  • Malnutrition
  • Previous treatment with excluded medications

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (10)

Baptist Medical Center South

Montgomery, Alabama, 36116, United States

Location

Associated Foot and Ankle Specialists

Phoenix, Arizona, 85015, United States

Location

Eden Podiatry Group

Castro Valley, California, 94546, United States

Location

PPH Center for Wound Care and Hyperbaric Medicine

Poway, California, 92064, United States

Location

Wound Healing Center

Terre Haute, Indiana, 47807, United States

Location

Southside Hospital

Bay Shore, New York, 11706, United States

Location

St Luke's Roosevelt

New York, New York, 10025, United States

Location

Center for Advanced Wound Care

Reading, Pennsylvania, 19601, United States

Location

Warren General Hospital

Warren, Pennsylvania, 16365, United States

Location

Hyperbaric and Wound Care Associates

Milwaukee, Wisconsin, 53215, United States

Location

MeSH Terms

Conditions

Venous InsufficiencyLeg UlcerVaricose Ulcer

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular DiseasesSkin UlcerSkin DiseasesSkin and Connective Tissue DiseasesVaricose Veins

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

December 28, 2005

First Posted

December 29, 2005

Study Start

September 1, 2005

Last Updated

June 5, 2006

Record last verified: 2006-06

Locations

US(10)