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

History of Changes

Tracking Information

First Received Date ^ICMJE

February 7, 2008

Last Updated Date

February 20, 2013

Start Date ^ICMJE

February 2008

Primary Completion Date

September 2009 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

wound healing [ Time Frame: 20 weeks ] [ Designated as safety issue: Yes ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00720239 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Taliderm Dressing for Venous Ulcers

Official Title ^ICMJE

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.

Brief Summary

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.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 0

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Condition ^ICMJE

Venous Stasis Ulcers
Venous Insufficiency

Intervention ^ICMJE

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.

Study Arm (s)

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

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

August 2010

Primary Completion Date

September 2009 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

45 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT00720239

Other Study ID Numbers ^ICMJE

86606

Has Data Monitoring Committee

Yes

Responsible Party

Teresa Kelechi, Medical University of South Carolina

Study Sponsor ^ICMJE

Medical University of South Carolina

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Teresa J Kelechi, PhD, RN

Medical University of South Carolina

Information Provided By

Medical University of South Carolina

Verification Date

February 2013

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

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