Evaluation of Bilayered Cellular Matrix (OrCel) for the T... | NCT00270946

Studies
Evaluation of Bilayered Cellular Matrix (OrCel) for the Treatment of Venous Ulcers

NCT00270946

Sponsor

Ortec International

Status

Completed

Last Update Posted

Dec 29, 2005Estimated

Enrollment

130

Phase

Not Applicable

Conditions

Venous Leg Ulcer
Venous Stasis Ulcer

Interventions

Bilayered Cellular Matrix (OrCel)

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2005

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Not provided

Start Date

Apr 2002

Primary Completion Date

Not provided

Completion Date

Dec 2003

First Submitted Date

Dec 28, 2005

First Submission Date that Met QC Criteria

Dec 28, 2005

First Posted Date

Dec 29, 2005Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 28, 2005

Last Update Posted Date

Dec 29, 2005Estimated

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

130

Name	Type	Description	Arm Group Labels	Other Names
Bilayered Cellular Matrix (OrCel)	Device

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Investigator assessment of wound healing

Secondary Outcomes

Measure	Description	Time Frame
Planimetric assessment of wound healing
Photographic assessment of wound healing

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

85 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Terry Treadwell, MD		Montgomery	Alabama	33134	United States

Condition Browse Module

MeSH Terms

ID	Term
D014647	Varicose Ulcer

Ancestor Terms

ID	Term
D014648	Varicose Veins
D014652	Vascular Diseases
D002318	Cardiovascular Diseases
D007871	Leg Ulcer

Browse Leaves

Not provided

Browse Branches

Not provided