Evaluate the Impact of Drawtex in Venous Leg Ulcers

NCT ID: NCT01319123

Last Updated: 2012-10-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-10-31

Study Completion Date

2011-08-31

Brief Summary

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This is a clinical study to comparatively evaluate the impact of Drawtex wound dressing against wound bioburden in moderately to highly exuding venous leg ulcers.

Detailed Description

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Each subject is expected to participate in this study for a period of four weeks or until reepithelialization, whichever occurs first. Subjects may participate for an additional period of four weeks or until reepithelialization, whichever occurs first: this it to be decided by the investigator and will be determined by the accessibility of the patient (physical location) and the suitability of the wound to further treatment. The maximum time period for the study is 8 weeks. The minimum time frame is at least 4 week, or until reepithelialization occurs.

Conditions

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Moderatley to Highly Exuding Venous Leg Ulcers

Keywords

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dressing for venous leg ulcers

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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wound dressing

The dressing is indicated for moderately to heavily exuding wounds such as venous leg ulcers.

Group Type OTHER

Drawtex dressing

Intervention Type DEVICE

The dressing is indicated for moderately to heavily exuding wounds such as venous leg ulcers

Interventions

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Drawtex dressing

The dressing is indicated for moderately to heavily exuding wounds such as venous leg ulcers

Intervention Type DEVICE

Other Intervention Names

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Beier Drawtex

Eligibility Criteria

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Inclusion Criteria

* Subject \> 18 years.
* Subject is attending weekly office visits at SW Wound Care Center as an out-patient.
* Subject has a moderately to highly exudative venous leg ulcer that would be indicated for treatment with Drawtex
* Subject or is informed about the trial, understands its nature of the study and provides written informed consent prior to study enrollment.
* Subject is willing and able to comply with all specified care and visit requirements

* Subject refuses to participate in the study.
* Subject already participates in the this study with one wound (only one wound per subject is allowed)
* Subject has known sensitivity to the trial product or any of its compounds.
* Subject is expected to be non-compliant.
* Subject's lesion is a primary skin cancer.
* Subject's lesion is the manifestation of a metastasis.
* Subject is pregnant.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Beier Drawtex Healthcare, (PTY). Ltd

UNKNOWN

Sponsor Role collaborator

Southwest Regional Wound Care Center

OTHER

Sponsor Role lead

Responsible Party

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Randall Wolcott

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Randall D Wolcott, M.D.

Role: PRINCIPAL_INVESTIGATOR

Southwest Regional Wound Care

Locations

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Southwest Regional Wound Care Center

Lubbock, Texas, United States

Site Status

Countries

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United States

Other Identifiers

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56-RW-019

Identifier Type: -

Identifier Source: org_study_id