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Taliderm Dressing for Venous Ulcers

Primary Purpose

Venous Stasis Ulcers, Venous Insufficiency

Status
Completed
Phase
Early Phase 1
Locations
United States
Study Type
Interventional
Intervention
Taliderm wound healing dressing
Sponsored by
Medical University of South Carolina
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Venous Stasis Ulcers

Eligibility Criteria

45 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Roper St. Francis Hospitals

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

No Intervention

Experimental

Experimental

Experimental

Arm Label

0

1

2

3

Arm Description

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

Outcomes

Primary Outcome Measures

wound healing

Secondary Outcome Measures

Full Information

First Posted
February 7, 2008
Last Updated
February 20, 2013
Sponsor
Medical University of South Carolina
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1. Study Identification

Unique Protocol Identification Number
NCT00720239
Brief Title
Taliderm Dressing for Venous Ulcers
Official Title
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.
Study Type
Interventional

2. Study Status

Record Verification Date
February 2013
Overall Recruitment Status
Completed
Study Start Date
February 2008 (undefined)
Primary Completion Date
September 2009 (Actual)
Study Completion Date
August 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Medical University of South Carolina

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Venous Stasis Ulcers, Venous Insufficiency

7. Study Design

Primary Purpose
Treatment
Study Phase
Early Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
0
Arm Type
No Intervention
Arm Title
1
Arm Type
Experimental
Arm Description
Experimental Group 1 (n = 10) will receive TalidermR to the wound once during the treatment phase.
Arm Title
2
Arm Type
Experimental
Arm Description
Experimental Group 2 (n = 10) will receive TalidermR to the wound every other week during the treatment phase.
Arm Title
3
Arm Type
Experimental
Arm Description
Experimental Group 3 (n = 10) will receive TalidermR to the wound every three weeks during the treatment phase.
Intervention Type
Other
Intervention Name(s)
Taliderm wound healing dressing
Intervention Description
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.
Primary Outcome Measure Information:
Title
wound healing
Time Frame
20 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Teresa J Kelechi, PhD, RN
Organizational Affiliation
Medical University of South Carolina
Official's Role
Principal Investigator
Facility Information:
Facility Name
Roper St. Francis Hospitals
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29401
Country
United States

12. IPD Sharing Statement

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Taliderm Dressing for Venous Ulcers

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