NCT00270946

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

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

Enrollment
130

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2002

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2002

Completed
1.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2003

Completed
2.1 years 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

December 29, 2005

Status Verified

December 1, 2005

First QC Date

December 28, 2005

Last Update Submit

December 28, 2005

Conditions

Venous Leg UlcerVenous Stasis Ulcer

Keywords

Venous leg ulcerOrCelCompression therapy

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 the ulcer site
  • Uncontrolled diabetes mellitus
  • Previous treatment with excluded medications

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Terry Treadwell, MD

Montgomery, Alabama, 33134, United States

Location

MeSH Terms

Conditions

Varicose Ulcer

Condition Hierarchy (Ancestors)

Varicose VeinsVascular DiseasesCardiovascular DiseasesLeg UlcerSkin UlcerSkin DiseasesSkin and Connective Tissue Diseases

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

April 1, 2002

Study Completion

December 1, 2003

Last Updated

December 29, 2005

Record last verified: 2005-12

Locations

US(1)