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Taliderm Dressing for Venous Ulcers

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Teresa Kelechi, Medical University of South Carolina
ClinicalTrials.gov Identifier:
NCT00720239
First received: February 7, 2008
Last updated: February 20, 2013
Last verified: February 2013

February 7, 2008
February 20, 2013
February 2008
September 2009   (final data collection date for primary outcome measure)
wound healing [ Time Frame: 20 weeks ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT00720239 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Taliderm Dressing for Venous Ulcers
Safety and Wound Healing Efficacy of the TalidermR Wound Dressing a Poly-N-acetyl Glucosamine-derived Membrane Material in Humans With Venous Stasis Ulcers: a Pilot Study.

The study will test a new wound healing dressing called Taliderm® on leg ulcers caused by chronic venous insufficiency (CVI). Some people with CVI have poor vein circulation that causes ulcers to develop on the lower legs. This new dressing is hoped to help the ulcers heal more quickly. The study hypothesis is to determine whether the TalidermR Wound Dressing, a poly-N-acetyl glucosamine (pGlcNAc) derived membrane material expedites wound healing in humans with venous stasis ulcers.

Not Provided
Interventional
Phase 0
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Venous Stasis Ulcers
  • Venous Insufficiency
Other: Taliderm wound healing dressing

Taliderm wound healing dressing will be applied to the wound site as follows depending on assignment to group:

Control group receives no intervention. Experimental Group 1 (n = 10) will receive TalidermR only one time at the beginning of the treatment phase.

Experimental Group 2 (n = 10) will receive TalidermR to the wound every other week during the treatment phase.

Experimental Group 3 (n = 10) will receive TalidermR to the wound every three weeks during the treatment phase.

  • No Intervention: 0
  • Experimental: 1
    Experimental Group 1 (n = 10) will receive TalidermR to the wound once during the treatment phase.
    Intervention: Other: Taliderm wound healing dressing
  • Experimental: 2
    Experimental Group 2 (n = 10) will receive TalidermR to the wound every other week during the treatment phase.
    Intervention: Other: Taliderm wound healing dressing
  • Experimental: 3
    Experimental Group 3 (n = 10) will receive TalidermR to the wound every three weeks during the treatment phase.
    Intervention: Other: Taliderm wound healing dressing
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
50
August 2010
September 2009   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Adults ≥45 years of age
  • Diagnosis venous partial thickness ulcer diagnosed within the past
  • 4 weeks without recent enzymatic, autolytic or chemical treatment
  • Viable and clean wound bed with granulation tissue and ≥ 90% free of necrotic debris
  • Wound measures between 5 and 20 cm2
  • Extends through epidermis and into the dermis

Exclusion Criteria:

  • Full thickness ulcers extending beyond the dermis
  • Current wound, skin, or systemic infection
  • Wound bed ≤90% free of necrotic debris
  • Recent treatment with enzymatic, autolytic or chemical agents
  • History or collagen vascular disease, severe arterial disease, organ transplant, Charcot, sickle cell
  • Insufficient blood supply to ulcer (ankle-brachial index <.8 or >1.3)
  • History of radiation therapy to the site
  • Cellulitis/osteomyelitis/avascular ulcer bed
  • Currently receiving hemodialysis
  • Pregnancy
  • Currently receiving treatment with another investigational drug or device or within the past 30 days
  • Unable to comply with the study protocol
Both
45 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00720239
86606
Yes
Teresa Kelechi, Medical University of South Carolina
Medical University of South Carolina
Not Provided
Principal Investigator: Teresa J Kelechi, PhD, RN Medical University of South Carolina
Medical University of South Carolina
February 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP