Evaluate the Impact of Drawtex in Venous Leg Ulcers

This study has been completed.
Sponsor:
Collaborator:
Beier Drawtex Healthcare, (PTY). Ltd
Information provided by (Responsible Party):
Randall Wolcott, Southwest Regional Wound Care Center
ClinicalTrials.gov Identifier:
NCT01319123
First received: March 10, 2011
Last updated: October 29, 2012
Last verified: October 2012
  Purpose

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.


Condition Intervention
Moderatley to Highly Exuding Venous Leg Ulcers
Device: Drawtex dressing

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Clinical Study to Comparatively Evaluate the Impact of Drawtex Wound Dressing Against Wound Bioburden in Moderately to Highly Exuding Venous Leg Ulcers

Resource links provided by NLM:


Further study details as provided by Southwest Regional Wound Care Center:

Primary Outcome Measures:
  • To investigate the impact of Drawtex on wound surface bioburden. [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
    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 Outcome Measures:
  • Tolerance [ Time Frame: 2 years ] [ Designated as safety issue: No ]

    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


Enrollment: 10
Study Start Date: October 2010
Study Completion Date: August 2011
Primary Completion Date: August 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
wound dressing
The dressing is indicated for moderately to heavily exuding wounds such as venous leg ulcers.
Device: Drawtex dressing
The dressing is indicated for moderately to heavily exuding wounds such as venous leg ulcers
Other Name: Beier Drawtex

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01319123

Locations
United States, Texas
Southwest Regional Wound Care Center
Lubbock, Texas, United States, 79410
Sponsors and Collaborators
Southwest Regional Wound Care Center
Beier Drawtex Healthcare, (PTY). Ltd
Investigators
Principal Investigator: Randall D Wolcott, M.D. Southwest Regional Wound Care
  More Information

No publications provided

Responsible Party: Randall Wolcott, Principal Investigator, Southwest Regional Wound Care Center
ClinicalTrials.gov Identifier: NCT01319123     History of Changes
Other Study ID Numbers: 56-RW-019
Study First Received: March 10, 2011
Last Updated: October 29, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Southwest Regional Wound Care Center:
dressing for venous leg ulcers

Additional relevant MeSH terms:
Ulcer
Varicose Ulcer
Leg Ulcer
Pathologic Processes
Varicose Veins
Vascular Diseases
Cardiovascular Diseases
Skin Ulcer
Skin Diseases

ClinicalTrials.gov processed this record on September 16, 2014