Taliderm Dressing for Venous Ulcers

Venous Insufficiency Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00720239
• Other study ID #: 86606
• Status: Completed
• Phase: Phase 0
• First received: February 7, 2008
• Last updated: February 20, 2013
• Start date: February 2008
• Est. completion date: August 2010

Study information

• Verified date: February 2013
• Source: Medical University of South Carolina
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: August 2010
• Est. primary completion date: September 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 45 Years and older

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Postphlebitic Syndrome
• Postthrombotic Syndrome
• Ulcer
• Varicose Ulcer
• Venous Insufficiency
• Venous Stasis Ulcers

Intervention

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.

Locations

Country	Name	City	State
United States	Roper St. Francis Hospitals	Charleston	South Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of South Carolina

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	wound healing		20 weeks	Yes