Taliderm Dressing for Venous Ulcers

NCT ID: NCT00720239

Last Updated: 2013-02-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-02-29
• Study Completion Date: 2010-08-31

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

0

Group Type: NO_INTERVENTION

No interventions assigned to this group

1

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

Group Type: EXPERIMENTAL

Taliderm wound healing dressing

Intervention Type: 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.

2

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

Group Type: EXPERIMENTAL

Taliderm wound healing dressing

Intervention Type: 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.

3

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

Group Type: EXPERIMENTAL

Taliderm wound healing dressing

Intervention Type: 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.

Interventions

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.

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Medical University of South Carolina

OTHER

Sponsor Role: lead

Responsible Party

Teresa Kelechi

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Teresa J Kelechi, PhD, RN

Role: PRINCIPAL_INVESTIGATOR

Medical University of South Carolina

Locations

Roper St. Francis Hospitals

Charleston, South Carolina, United States

Countries

United States

Other Identifiers

86606

Identifier Type: -

Identifier Source: org_study_id