Evaluate the Impact of Drawtex in Venous Leg Ulcers

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

Study Overview

• Status: Completed
• Conditions: Moderatley to Highly Exuding Venous Leg Ulcers
• Intervention / Treatment: Device: Drawtex dressing

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.

• Study Type: Interventional
• Enrollment (Actual): 10
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Texas
    • Lubbock, Texas, United States, 79410
      • Southwest Regional Wound Care Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: 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 Names: Beier Drawtex

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	2 years

Collaborators and Investigators

• Sponsor: Southwest Regional Wound Care Center
• Collaborators: Beier Drawtex Healthcare, (PTY). Ltd
• Investigators: Principal Investigator: Randall D Wolcott, M.D., Southwest Regional Wound Care

Study record dates

Study Major Dates

• Study Start: October 1, 2010
• Primary Completion (Actual): August 1, 2011
• Study Completion (Actual): August 1, 2011

Study Registration Dates

• First Submitted: March 10, 2011
• First Submitted That Met QC Criteria: March 17, 2011
• First Posted (Estimate): March 21, 2011

Study Record Updates

• Last Update Posted (Estimate): October 30, 2012
• Last Update Submitted That Met QC Criteria: October 29, 2012
• Last Verified: October 1, 2012

More Information

Terms related to this study

• Keywords: dressing for venous leg ulcers
• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Skin Diseases; Skin Ulcer; Varicose Veins; Ulcer; Leg Ulcer; Varicose Ulcer
• Other Study ID Numbers: 56-RW-019