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.

Study Overview

• Status: Completed
• Conditions: Venous Insufficiency; Venous Stasis Ulcers
• Intervention / Treatment: Other: Taliderm wound healing dressing

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Early Phase 1

Contacts and Locations

Study Locations

• United States
  • South Carolina
    • Charleston, South Carolina, United States, 29401
      • Roper St. Francis Hospitals

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 45 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
wound healing	20 weeks

Collaborators and Investigators

• Sponsor: Medical University of South Carolina

Study record dates

Study Major Dates

• Study Start: February 1, 2008
• Primary Completion (Actual): September 1, 2009
• Study Completion (Actual): August 1, 2010

Study Registration Dates

• First Submitted: February 7, 2008
• First Submitted That Met QC Criteria: July 21, 2008
• First Posted (Estimate): July 22, 2008

Study Record Updates

• Last Update Posted (Estimate): February 22, 2013
• Last Update Submitted That Met QC Criteria: February 20, 2013
• Last Verified: February 1, 2013

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Skin Diseases; Leg Ulcer; Skin Ulcer; Varicose Veins; Ulcer; Varicose Ulcer; Venous Insufficiency
• Other Study ID Numbers: 86606

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No