Taliderm Dressing for Venous Ulcers

Early Phase 1

Completed

• Conditions: Venous Stasis Ulcers; Venous Insufficiency
• Interventions: Other: Taliderm wound healing dressing

• Registration Number: NCT00720239
• Lead Sponsor: Medical University of South Carolina

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 available

Study Timeline

• Study Start: 2008-02
• Study First Submitted: 2008-02-07
• Study First Submitted QC: 2008-07-21
• Study First Posted: 2008-07-22
• Primary Completion: 2009-09
• Study Completion: 2010-08
• Status Verified: 2013-02
• Last Update Submitted: 2013-02-20
• Last Update Posted: 2013-02-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
1	Taliderm wound healing dressing	Experimental Group 1 (n = 10) will receive TalidermR to the wound once during the treatment phase.
2	Taliderm wound healing dressing	Experimental Group 2 (n = 10) will receive TalidermR to the wound every other week during the treatment phase.
3	Taliderm wound healing dressing	Experimental Group 3 (n = 10) will receive TalidermR to the wound every three weeks during the treatment phase.

Primary Outcome Measures

Name	Time	Method
wound healing	20 weeks

Trial Locations

Locations (1)

Roper St. Francis Hospitals; 🇺🇸 Charleston, South Carolina, United States