Randomized Controlled 8-week Crossover Evaluation of Comp... | NCT00301496 | Trialant

Home
Search
Collections
Views
Audits

Terms of Service
Privacy Policy

Randomized Controlled 8-week Crossover Evaluation of Comp... | NCT00301496 | Trialant

Studies
Randomized Controlled 8-week Crossover Evaluation of Compression Bandage Systems for Venous Leg Ulcers

NCT00301496

Sponsor

Solventum US LLC

Status

Completed

Last Update Posted

Oct 2, 2024Actual

Enrollment

80

Phase

Not Applicable

Conditions

Venous Ulcer

Interventions

Coban 2 Layer Compression System

Countries

United States
Canada
United Kingdom

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

NCT00301496

Obsolete or Duplicate NCT IDs

Not provided

Organization Study

05-010302

Secondary IDs

Not provided

Brief Title

Randomized Controlled 8-week Crossover Evaluation of Compression Bandage Systems for Venous Leg Ulcers

Official Title

Randomized Controlled Eight Week Cross-over Clinical Evaluation of the 3M Coban 2-Layer Compression System to Evaluate the Product Performance in Patients With Venous Leg Ulcers

Acronym

Not provided

Organization

Solventum US LLCINDUSTRY

Status Module

Record Verification Date

Sep 2024

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

No

Start Date

Mar 2006

Primary Completion Date

Not provided

Completion Date

Apr 2007Actual

First Submitted Date

Mar 10, 2006

First Submission Date that Met QC Criteria

Mar 10, 2006

First Posted Date

Mar 13, 2006Estimated

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

Sep 30, 2024

Last Update Posted Date

Oct 2, 2024Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Not provided

Lead Sponsor

Solventum US LLCINDUSTRY

Collaborators

Name	Class
3M	INDUSTRY

Oversight Module

No data available

No data is available for this block.

Description Module

Brief Summary

The purpose of this study is to evaluate the product performance of a new 2-layer compression bandage for the treatment of venous leg ulcers.

Detailed Description

The purpose of this study is to evaluate the product performance of a new 2-layer compression bandage for the treatment of venous leg ulcers. The new bandage is a 2-layer compression system. It will be used over primary dressings to provide the compression that is beneficial to venous leg ulcers.

Conditions Module

Conditions

Venous Ulcer

Keywords

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

80

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Coban 2 Layer Compression System	Device

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Product Performance

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

venous leg ulcer
patient can walk

Exclusion Criteria:

cancerous ulcers
diabetic foot ulcer

Accepts Healthy Volunteers

No

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

21 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Christine Moffatt, PhD, MA, RGN	Centre for Research and Implementation of Clinical Practice	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Institute for Advanced Wound Care		Montgomery	Alabama	36111	United States
Center for Clinical Research, Inc.

References Module

No data available

No data is available for this block.

IPD Sharing Statement Module

No data available

No data is available for this block.

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

Jul 10, 2026

Removed Countries

Not provided

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

MeSH Terms

Intervention Browse Module

No data available

No data is available for this block.

Randomized

Intervention Model

Crossover Assignment

Intervention Model Description

Not provided

Primary Purpose

Treatment

Observational Model

Not provided

Time Perspective

Not provided

Masking Info

Masking

None (Open Label)

Masking Description

Not provided

Who Masked

Not provided

Castro Valley

California

94546

United States

Gwinnet Hospital System

Lawrenceville

Georgia

30045

United States

Wound Healing and Treatment Center - Silver Cross Hospital

Joliet

Illinois

60432

United States

Wound Healing Center

Terre Haute

Indiana

47807

United States

Dermatology Clinic - Montreal General Hospital

Montreal

Quebec

H3G 1A4

Canada

Dermatology Clinic

Mississauga, Ontario

L4Y 1A6

Canada

Wound Healing Research Unit

Cardiff

United Kingdom

Grantham & District Hospital

Grantham

United Kingdom

Clayponds Hospital

London

United Kingdom

ID	Term
D014647	Varicose Ulcer

Ancestor Terms

ID	Term
D014648	Varicose Veins
D014652	Vascular Diseases
D002318	Cardiovascular Diseases
D007871	Leg Ulcer
D012883	Skin Ulcer
D012871	Skin Diseases
D017437	Skin and Connective Tissue Diseases

Browse Leaves

Not provided

Browse Branches

Not provided