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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00720239
Other study ID # 86606
Secondary ID
Status Completed
Phase Phase 0
First received February 7, 2008
Last updated February 20, 2013
Start date February 2008
Est. completion date August 2010

Study information

Verified date February 2013
Source Medical University of South Carolina
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 50
Est. completion date August 2010
Est. primary completion date September 2009
Accepts healthy volunteers No
Gender Both
Age group 45 Years and older
Eligibility 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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment


Intervention

Other:
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.

Locations

Country Name City State
United States Roper St. Francis Hospitals Charleston South Carolina

Sponsors (1)

Lead Sponsor Collaborator
Medical University of South Carolina

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary wound healing 20 weeks Yes
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