Evaluate the Impact of Drawtex in Venous Leg Ulcers

NCT01319123 | Completed

• 1 other identifier: 56-RW-019
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Moderatley to Highly Exuding Venous Leg Ulcers

Keywords

dressing for venous leg ulcers

Outcome Measures

Primary Outcomes (1)

• To investigate the impact of Drawtex on wound surface bioburden.

  The dressing is indicated for moderately to heavily exuding wounds such as venous leg ulcers.• The safety of Drawtex will be measured by the number and type of any adverse events. Patient's tolerance and acceptance of the different dressings

  2 years

Secondary Outcomes (1)

• Tolerance

  2 years

Study Arms (1)

wound dressing

OTHER

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

Device: Drawtex dressing

Interventions

Drawtex dressing DEVICE

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

Also known as: Beier Drawtex

wound dressing

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Southwest Regional Wound Care Center: lead
• Beier Drawtex Healthcare, (PTY). Ltd: collaborator

Study Sites (1)

Southwest Regional Wound Care Center

Lubbock, Texas, 79410, United States

Location

Study Officials

• Randall D Wolcott, M.D.

  Southwest Regional Wound Care

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 10, 2011
• First Posted: March 21, 2011
• Study Start: October 1, 2010
• Primary Completion: August 1, 2011
• Study Completion: August 1, 2011
• Last Updated: October 30, 2012

Record last verified: 2012-10

Locations

US (1)