Taliderm Dressing for Venous Ulcers

Medical University of South Carolina (MUSC)

Status and phase: Completed; Early Phase 1

Conditions: Venous Insufficiency; Venous Stasis Ulcers

Treatments: Other: Taliderm wound healing dressing

Study type: Interventional

Funder types: Other

Identifiers

NCT00720239

86606

Details and patient eligibility

About

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.

Enrollment: 50 patients

Sex: All

Ages: 45+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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50 participants in 4 patient groups

0

No Intervention group

1

Experimental group

Description:

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

Treatment:

Other: Taliderm wound healing dressing

2

Experimental group

Description:

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

Treatment:

Other: Taliderm wound healing dressing

3

Experimental group

Description:

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

Treatment:

Other: Taliderm wound healing dressing