Venous UlcerPhase 4NCT01396304
Restore Calcium Alginate Dressing, Silver vs Aquacel Ag in the Treatment of Critically Colonized Venous Leg Ulcers
A Phase 4 study testing Restore Calcium Alginate Dressing and AquaCel Ag Wound Dressing in people with Venous Ulcer and Infection, run by Hollister Wound Care LLC at 5 sites in United States.
Trial summary
Calcium alginate dressings with silver have been found to be safe and effective for use for leg ulcers. The primary objective is to compare Restore Calcium Alginate Dressing, Silver to AqualCel Ag Dressing on the following parameters: No further progression toward infection (bioburden), ease of application and… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Venous Ulcer, Infection
- What is being tested?
- Restore Calcium Alginate Dressing and AquaCel Ag Wound Dressing
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- 5 sitesUnited States
- Study dates
- Oct 2011to Feb 2013
- Phase
- Phase 4
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Is 18 years or older; male or female.
- Previous diagnosis of venous insufficiency proven by a positive venous duplex with reflux.
- Has a venous ulcer with a wound area between 5 cm2 - 40 cm2.
- Has an ankle brachial index (ABI) >0.8.
- Has a venous ulcer with duration less than 24 months.
- Has a venous ulcer which is critically colonized (not infected) based on the Lazareth Study Model. Ulcers are considered to be critically colonized if at least three of the five following signs are present:
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- Severe spontaneous pain between two dressing changes,Perilesional erythema,Local edema,Malodour,Heavy Exudation
- Is currently using Profore as their standard of care.
- Has not received antibiotics for 6 weeks prior to enrollment.
Who cannot join
- Has an allergy to one of the components of the dressings (calcium alginate, hydrocolloid [carboxymethylceullose], silver).
- Is currently on antibiotics.
- Has a negative venous duplex.
- Is unable to tolerate 4 layer compression.
- Is unable to continue contact with the investigator for a period of at least two weeks.
- Is unwilling or unable to comply with the study protocol.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
Lake Washington Vascular Surgeons
Bellevue, Washington, 98004
Wound Institute & Research Center
Dunmore, Pennsylvania, 18512
Bayshore Community Hospital
Holmdel, New Jersey, 07733
LSU Health Sciences Center
Shreveport, Louisiana, 71103
Palms of Pasadena Hospital
St. Petersburg, Florida, 33707
About this study
Calcium alginate dressings with silver have been found to be safe and effective for use for leg ulcers. The primary objective is to compare Restore Calcium Alginate Dressing, Silver to AqualCel Ag Dressing on the following parameters: No further progression toward infection (bioburden), ease of application and removal, and percent progression to closure. The secondary objective is to obtain photographic documentation of the leg ulcers during the course of the study.
- Conditions
- Venous Ulcer, Infection
- Being tested
- Restore Calcium Alginate Dressing, AquaCel Ag Wound Dressing
- Keywords
- leg ulcer, infection, closure, wound dressings
- Medical subject headings
- Varicose Ulcer, Infections, Leg Ulcer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Restore Calcium Alginate DressingDevice
Wound dressing appropriate for venous leg ulcers. Dressing to be changed minimally once per week.
AquaCel Ag Wound DressingDevice
Wound dressing appropriate for venous leg ulcers. Dressing to be changed minimally once per week.
| Study group | Role | What they receive |
|---|---|---|
| Restore Calcium Alginate Dressing Silver | Experimental | Restore Calcium Alginate Dressing Silver under compression wrap Receives: Device: Restore Calcium Alginate Dressing |
| Aquacel Ag Wound Dressing | Active comparator | Aquacel Ag Wound Dressing under compression wrap Receives: Device: AquaCel Ag Wound Dressing |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary objective is to compare Restore Calcium Alginate Dressing, Silver to AqualCel Ag Dressing on the following parameters: No further progression toward infection (bioburden), ease of application and removal, and percent progression to closure.
Measured: Observations will be collected over 6 weeks for a total of 7 visits
Secondary outcomes (1)
The secondary objective is to obtain photographic documentation of the venous leg ulcers during the course of the study.
Measured: Observations will be collected over 6 weeks in a total of 7 visits.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2011 (estimated)
- Study startOct 2011
- Primary completionFeb 2013
- Study completionFeb 2013
Why it stopped: slow accrual
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Venous UlcerStudies 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
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hollister Wound Care LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Rita Kaurs, MSHSA MT NMT, Study director, Hollister Incorporated
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01396304
- Sponsor's protocol ID
- 4835-W
- Status last verified
- Feb 2013
- First submitted
- 14 Jul 2011
- Last updated
- 15 Feb 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Restore Calcium Alginate Dressing, Silver vs Aquacel Ag in the Treatment of Critically Colonized Venous Leg Ulcers
- ClinicalTrials.gov ID
- NCT01396304
- Acronym / sponsor ID
- 4835-W
- Conditions
- Venous Ulcer, Infection
- Keywords
- leg ulcer, infection, closure, wound dressings
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: slow accrual
- Enrolment
- 19 participants (actual)
- Lead sponsor
- Hollister Wound Care LLCIndustry (pharma, biotech, devices)
- Study start
- Oct 2011
- Primary completion
- Feb 2013 (actual)
- Study completion
- Feb 2013 (actual)
- First posted
- 18 Jul 2011 (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.
Calcium alginate dressings with silver have been found to be safe and effective for use for leg ulcers. The primary objective is to compare Restore Calcium Alginate Dressing, Silver to AqualCel Ag Dressing on the following parameters: No further progression toward infection (bioburden), ease of application and removal, and percent progression to closure. The secondary objective is to obtain photographic documentation of the leg ulcers during the course of the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Restore Calcium Alginate Dressing Silver | Experimental | Device: Restore Calcium Alginate DressingRestore Calcium Alginate Dressing Silver under compression wrap |
| Aquacel Ag Wound Dressing | Active comparator | Device: AquaCel Ag Wound DressingAquacel Ag Wound Dressing under compression wrap |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Is 18 years or older; male or female.
- Previous diagnosis of venous insufficiency proven by a positive venous duplex with reflux.
- Has a venous ulcer with a wound area between 5 cm2 - 40 cm2.
- Has an ankle brachial index (ABI) >0.8.
- Has a venous ulcer with duration less than 24 months.
Key exclusion criteria (6 listed)
- Has an allergy to one of the components of the dressings (calcium alginate, hydrocolloid [carboxymethylceullose], silver).
- Is currently on antibiotics.
- Has a negative venous duplex.
- Is unable to tolerate 4 layer compression.
- Is unable to continue contact with the investigator for a period of at least two weeks.
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 |
|---|---|---|
| Restore Calcium Alginate DressingWound dressing appropriate for venous leg ulcers. Dressing to be changed minimally once per week. | Device | Restore Calcium Alginate Dressing Silver |
| AquaCel Ag Wound DressingWound dressing appropriate for venous leg ulcers. Dressing to be changed minimally once per week. | Device | Aquacel Ag Wound Dressing |
Primary outcome
The primary objective is to compare Restore Calcium Alginate Dressing, Silver to AqualCel Ag Dressing on the following parameters: No further progression toward infection (bioburden), ease of application and removal, and percent progression to closure.
Time frame: Observations will be collected over 6 weeks for a total of 7 visits
1 secondary outcome
The secondary objective is to obtain photographic documentation of the venous leg ulcers during the course of the study.
Time frame: Observations will be collected over 6 weeks in a total of 7 visits.
Results and safety
The study was stopped early (reason given: slow accrual). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 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.
Rita Kaurs, MSHSA MT NMT study director
Hollister Incorporated
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Restore Calcium Alginate Dressing and AquaCel Ag Wound Dressing in people with Venous Ulcer and Infection, run by Hollister Wound Care LLC at 5 sites 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 9 inclusion and 6 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: stopped early, as of the sponsor's last update on 15 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 5 sites 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?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 was stopped early (reason given: slow accrual). Results are not available in the source record.
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?
The primary objective is to compare Restore Calcium Alginate Dressing, Silver to AqualCel Ag Dressing on the following parameters: No further progression toward infection (bioburden), ease of application and removal, and percent progression to closure. (time frame: Observations will be collected over 6 weeks for a total of 7 visits). 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 15 Feb 2013.