Back to resultsEvaluate the Impact of Drawtex in Venous Leg Ulcers
Primary Purpose
Moderatley to Highly Exuding Venous Leg Ulcers
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Drawtex dressing
Sponsored by
About this trial
This is an interventional treatment trial for Moderatley to Highly Exuding Venous Leg Ulcers focused on measuring dressing for venous leg ulcers
Eligibility 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.
Sites / Locations
- Southwest Regional Wound Care Center
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
wound dressing
Arm Description
The dressing is indicated for moderately to heavily exuding wounds such as venous leg ulcers.
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Tolerance
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
Full Information
NCT ID
NCT01319123
First Posted
March 10, 2011
Last Updated
October 29, 2012
Sponsor
Southwest Regional Wound Care Center
Collaborators
Beier Drawtex Healthcare, (PTY). Ltd
1. Study Identification
Unique Protocol Identification Number
NCT01319123
Brief Title
Evaluate the Impact of Drawtex in Venous Leg Ulcers
Official Title
Clinical Study to Comparatively Evaluate the Impact of Drawtex Wound Dressing Against Wound Bioburden in Moderately to Highly Exuding Venous Leg Ulcers
Study Type
Interventional
2. Study Status
Record Verification Date
October 2012
Overall Recruitment Status
Completed
Study Start Date
October 2010 (undefined)
Primary Completion Date
August 2011 (Actual)
Study Completion Date
August 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Southwest Regional Wound Care Center
Collaborators
Beier Drawtex Healthcare, (PTY). Ltd
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Moderatley to Highly Exuding Venous Leg Ulcers
Keywords
dressing for venous leg ulcers
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Actual)
8. Arms, Groups, and Interventions
Arm Title
wound dressing
Arm Type
Other
Arm Description
The dressing is indicated for moderately to heavily exuding wounds such as venous leg ulcers.
Intervention Type
Device
Intervention Name(s)
Drawtex dressing
Other Intervention Name(s)
Beier Drawtex
Intervention Description
The dressing is indicated for moderately to heavily exuding wounds such as venous leg ulcers
Primary Outcome Measure Information:
Title
To investigate the impact of Drawtex on wound surface bioburden.
Description
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
Time Frame
2 years
Secondary Outcome Measure Information:
Title
Tolerance
Description
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
Time Frame
2 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Randall D Wolcott, M.D.
Organizational Affiliation
Southwest Regional Wound Care
Official's Role
Principal Investigator
Facility Information:
Facility Name
Southwest Regional Wound Care Center
City
Lubbock
State/Province
Texas
ZIP/Postal Code
79410
Country
United States
12. IPD Sharing Statement
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Evaluate the Impact of Drawtex in Venous Leg Ulcers
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