Taliderm Dressing for Venous Ulcers

NCT00720239 | Completed Early Phase 1 DMC

• 1 other identifier: 86606
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Venous Stasis Ulcers; Venous Insufficiency

Outcome Measures

Primary Outcomes (1)

• wound healing

  20 weeks

Study Arms (4)

0

NO INTERVENTION

1

EXPERIMENTAL

Experimental Group 1 (n = 10) will receive TalidermR to the wound once during the treatment phase.

Other: Taliderm wound healing dressing

2

EXPERIMENTAL

Experimental Group 2 (n = 10) will receive TalidermR to the wound every other week during the treatment phase.

Other: Taliderm wound healing dressing

3

EXPERIMENTAL

Experimental Group 3 (n = 10) will receive TalidermR to the wound every three weeks during the treatment phase.

Other: Taliderm wound healing dressing

Interventions

Taliderm wound healing dressing OTHER

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.

1; 2; 3

Eligibility Criteria

• Age: 45 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults ≥45 years of age
• Diagnosis venous partial thickness ulcer diagnosed within the past
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Medical University of South Carolina: lead

Study Sites (1)

Roper St. Francis Hospitals

Charleston, South Carolina, 29401, United States

Location

MeSH Terms

Conditions

Varicose Ulcer; Venous Insufficiency

Condition Hierarchy (Ancestors)

Varicose Veins; Vascular Diseases; Cardiovascular Diseases; Leg Ulcer; Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Teresa J Kelechi, PhD, RN

  Medical University of South Carolina

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: February 7, 2008
• First Posted: July 22, 2008
• Study Start: February 1, 2008
• Primary Completion: September 1, 2009
• Study Completion: August 1, 2010
• Last Updated: February 22, 2013

Record last verified: 2013-02

Locations

US (1)