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Completed

NCT Number: NCT01319123

Evaluate the Impact of Drawtex in Venous Leg Ulcers

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.

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Key information

Conditions

Moderatley to Highly Exuding Venous Leg Ulcers

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Southwest Regional Wound Care Center

Lubbock, Texas, 79410, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Exclusion criteria

  • Subject has a lesion that does not meet the inclusion criteria.
  • 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.

Treatment and study plan

Drawtex dressing

Device

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

Other names: Beier Drawtex

Primary outcomes

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

    Time frame: 2 years

    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

Secondary outcomes

  1. Tolerance

    Time frame: 2 years

    To further investigate whether Drawtex

    • Will have an overall benefit on the wound healing process.
    • Patient's tolerance and acceptance of the dressings. The overall effect on wound healing, as expressed by percentages of necrosis, slough, granulation and/or epithelium at the wound surface.
    • Condition of periwound skin
    • Mobility restrictions, related to the dressing
    • The number of dressings per dressing change, the number of dressing changes and the amount of nursing time involved

Sponsors and collaborators

Lead sponsor

Southwest Regional Wound Care Center

Other

Collaborators

  • Beier Drawtex Healthcare, (PTY). Ltd

Registry information

Official study title

Clinical Study to Comparatively Evaluate the Impact of Drawtex Wound Dressing Against Wound Bioburden in Moderately to Highly Exuding Venous Leg Ulcers

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Mar 21, 2011
Registry last updated
Oct 30, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.