Taliderm Dressing for Venous Ulcers

Early Phase 1CompletedNCT00720239

Medical University of South Carolina50 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Venous Stasis Ulcers Venous Insufficiency

Interventions

Taliderm wound healing dressingOTHER

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.

Eligibility

Sex: ALLMin age: 45 Years

Medical Language ↔ Plain English

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

Locations (1)

Roper St. Francis Hospitals

Charleston, South Carolina, United States

Outcomes

Primary Outcomes

wound healing

Time frame: 20 weeks

Data from ClinicalTrials.gov

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