Taliderm Dressing for Venous Ulcers - Full Text View

Sponsored by:	Medical University of South Carolina
Information provided by:	Medical University of South Carolina
ClinicalTrials.gov Identifier:	NCT00720239

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

Drug Information available for: Glucosamine Glucosamine hydrochloride Glucosamine sulfate

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Single Group Assignment, Safety/Efficacy Study
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 ]

Estimated Enrollment:	50
Study Start Date:	February 2008
Estimated Study Completion Date:	March 2009
Estimated Primary Completion Date:	February 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: No Intervention The control arm (Group 5) will receive no intervention except standard of care for venous ulcers	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 once per week during the treatment phase. Experimental Group 3 (n = 10) will receive TalidermR to the wound every other week during the treatment phase. Experimental Group 4 (n = 10) will receive TalidermR to the wound every three weeks during the treatment phase.
2: Experimental Experimental Group 1 (n = 10) will receive TalidermR only one time at the beginning of 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 once per week during the treatment phase. Experimental Group 3 (n = 10) will receive TalidermR to the wound every other week during the treatment phase. Experimental Group 4 (n = 10) will receive TalidermR to the wound every three weeks during the treatment phase.
3: Experimental Experimental Group 2 (n = 10) will receive TalidermR to the wound once per 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 once per week during the treatment phase. Experimental Group 3 (n = 10) will receive TalidermR to the wound every other week during the treatment phase. Experimental Group 4 (n = 10) will receive TalidermR to the wound every three weeks during the treatment phase.
4: Experimental Experimental Group 3 (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 once per week during the treatment phase. Experimental Group 3 (n = 10) will receive TalidermR to the wound every other week during the treatment phase. Experimental Group 4 (n = 10) will receive TalidermR to the wound every three weeks during the treatment phase.
5: Experimental Experimental Group 4 (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 once per week during the treatment phase. Experimental Group 3 (n = 10) will receive TalidermR to the wound every other week during the treatment phase. Experimental Group 4 (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

Contacts

Contact: Teresa j Kelechi, PhD, RN

843-792-4602

kelechtj@musc.edu

Locations

United States, South Carolina
Roper St. Francis Hospitals	Recruiting
Charleston, South Carolina, United States, 29401
Contact: Teresa J Kelechi, PhD, RN 843-792-4602 kelechtj@musc.edu
Principal Investigator: Teresa J Kelechi, PhD, RN

Sponsors and Collaborators

Medical University of South Carolina

Investigators

Principal Investigator:

Teresa J Kelechi, PhD, RN

Medical University of South Carolina

More Information

Responsible Party:	Medical University of South Carolina ( Teresa J. Kelechi, PhD, RN )
Study ID Numbers:	86606
Study First Received:	February 7, 2008
Last Updated:	July 21, 2008
ClinicalTrials.gov Identifier:	NCT00720239
Health Authority:	United States: Institutional Review Board

Study placed in the following topic categories:

Peripheral Vascular Diseases
Skin Diseases
Ulcer
Vascular Diseases
Postthrombotic Syndrome
Thrombosis
Varicose Ulcer
Embolism and Thrombosis

Varicose Veins
Embolism
Venous Insufficiency
Phlebitis
Venous Thrombosis
Skin Ulcer
Postphlebitic Syndrome
Leg Ulcer

Additional relevant MeSH terms:

Pathologic Processes
Cardiovascular Diseases

ClinicalTrials.gov processed this record on January 16, 2009