Venous Insufficiency, Venous Stasis Ulcers
Conditions
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.
Interventions
OTHERTaliderm 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.
Sponsors
Medical University of South Carolina
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
45 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| wound healing | 20 weeks |
Countries
United States
Outcome results
None listed