Taliderm Dressing for Venous Ulcers (NCT00720239) | Clinical Trial Compass
CompletedEarly Phase 1
Taliderm Dressing for Venous Ulcers
United States50 participantsStarted 2008-02
Plain-language 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.
Who can participate
Age range
45 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.