Venous Stasis UlcersEarly Phase 1NCT00720239
Taliderm Dressing for Venous Ulcers
A Early Phase 1 study testing Taliderm wound healing dressing in people with Venous Stasis Ulcers and Venous Insufficiency, run by Medical University of South Carolina at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 45 years and older
- Conditions the study is for
- Venous Stasis Ulcers, Venous Insufficiency
- What is being tested?
- Taliderm wound healing dressing
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2008to Aug 2010
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Show all 12Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Roper St. Francis Hospitals
Charleston, South Carolina, 29401
About this study
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.
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.
- Conditions
- Venous Stasis Ulcers, Venous Insufficiency
- Being tested
- Taliderm wound healing dressing
- Medical subject headings
- Varicose Ulcer, Venous Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Taliderm wound healing dressingOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 0 | No intervention | Not described |
| 1 | Experimental | Experimental Group 1 (n = 10) will receive TalidermR to the wound once during the treatment phase. Receives: Other: Taliderm wound healing dressing |
| 2 | Experimental | Experimental Group 2 (n = 10) will receive TalidermR to the wound every other week during the treatment phase. Receives: Other: Taliderm wound healing dressing |
| 3 | Experimental | Experimental Group 3 (n = 10) will receive TalidermR to the wound every three weeks during the treatment phase. Receives: Other: Taliderm wound healing dressing |
What is being measured
The primary outcome is the main question the study is designed to answer.
wound healing
Measured: 20 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2008 (estimated)
- Study startFeb 2008
- Primary completionSep 2009
- Study completionAug 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Venous Stasis UlcersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of South Carolina
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Teresa Kelechi, Medical University of South Carolina
- Investigators
- Teresa J Kelechi, PhD, RN, Principal investigator, Medical University of South Carolina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00720239
- Sponsor's protocol ID
- 86606
- Status last verified
- Feb 2013
- First submitted
- 7 Feb 2008
- Last updated
- 22 Feb 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 22 Feb 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT00720239
- Acronym / sponsor ID
- 86606
- Conditions
- Venous Stasis Ulcers, Venous Insufficiency
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Medical University of South CarolinaUniversity, hospital or other
- Study start
- Feb 2008
- Primary completion
- Sep 2009 (actual)
- Study completion
- Aug 2010 (actual)
- First posted
- 22 Jul 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 0 | No intervention | – |
| 1 | Experimental | Other: Taliderm wound healing dressingExperimental Group 1 (n = 10) will receive TalidermR to the wound once during the treatment phase. |
| 2 | Experimental | Other: Taliderm wound healing dressingExperimental Group 2 (n = 10) will receive TalidermR to the wound every other week during the treatment phase. |
| 3 | Experimental | Other: Taliderm wound healing dressingExperimental Group 3 (n = 10) will receive TalidermR to the wound every three weeks during the treatment phase. |
Who may qualify
- Ages
- 45 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Taliderm wound healing dressingTaliderm 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. | Other | 1, 2, 3 |
Primary outcome
wound healing
Time frame: 20 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Feb 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Teresa J Kelechi, PhD, RN principal investigator
Medical University of South Carolina
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Taliderm wound healing dressing in people with Venous Stasis Ulcers and Venous Insufficiency, run by Medical University of South Carolina at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Feb 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
wound healing (time frame: 20 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Feb 2013.