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
  Purpose

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.


Condition Intervention Phase
Venous Stasis Ulcers
Venous Insufficiency
Other: Taliderm wound healing dressing
Phase 0

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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.

Further study details as provided by Medical University of South Carolina:

Primary Outcome Measures:
  • wound healing [ Time Frame: 20 weeks ] [ Designated as safety issue: Yes ]

Enrollment: 50
Study Start Date: February 2008
Study Completion Date: August 2010
Primary Completion Date: September 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: 0
Experimental: 1
Experimental Group 1 (n = 10) will receive TalidermR to the wound once during the treatment phase.
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.

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

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


  Eligibility

Ages Eligible for Study:   45 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00720239

Locations
United States, South Carolina
Roper St. Francis Hospitals
Charleston, South Carolina, United States, 29401
Sponsors and Collaborators
Medical University of South Carolina
Investigators
Principal Investigator: Teresa J Kelechi, PhD, RN Medical University of South Carolina
  More Information

No publications provided

Responsible Party: Teresa Kelechi, Professor, Medical University of South Carolina
ClinicalTrials.gov Identifier: NCT00720239     History of Changes
Other Study ID Numbers: 86606
Study First Received: February 7, 2008
Last Updated: February 20, 2013
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Postphlebitic Syndrome
Postthrombotic Syndrome
Varicose Ulcer
Ulcer
Venous Insufficiency
Phlebitis
Peripheral Vascular Diseases
Vascular Diseases
Cardiovascular Diseases
Venous Thrombosis
Thrombosis
Embolism and Thrombosis
Varicose Veins
Leg Ulcer
Skin Ulcer
Skin Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on April 16, 2014