Taliderm Dressing for Venous Ulcers

Study Overview
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Brief Summary
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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.

Official Title
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Safety and Wound Healing Efficacy of the TalidermR Wound Dressing a Poly-N-acetyl Glucosamine-derived Membrane Material in Humans With Venous Stasis Ulcers: a Pilot Study.

Conditions
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Venous Stasis Ulcers, Venous Insufficiency

Intervention / Treatment
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* Other: Taliderm wound healing dressing


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 45 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: 0<br> | |
| Experimental: 1<br>Experimental Group 1 (n = 10) will receive TalidermR to the wound once during the treatment phase. | Other: Taliderm wound healing dressing<br>* 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.<br>|
| Experimental: 2<br>Experimental Group 2 (n = 10) will receive TalidermR to the wound every other week during the treatment phase. | Other: Taliderm wound healing dressing<br>* 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.<br>|
| Experimental: 3<br>Experimental Group 3 (n = 10) will receive TalidermR to the wound every three weeks during the treatment phase. | Other: Taliderm wound healing dressing<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| wound healing |  | 20 weeks |