Foot UlcerPhase 4NCT00235196
Evaluation of the Clinical Effectiveness of a Collagen-ORC Antimicrobial Matrix in Full-Thickness, Neuropathic Diabetic Foot Ulcers
A Phase 4 study testing Collagen ORC Antimicrobial Matrix (CAM) in people with Foot Ulcer, run by Ethicon, Inc. at 3 sites in United States.
Trial summary
This is a randomized (1:1), prospective, open label, multicenter, comparative study to be examine the effectiveness of Collagen-ORC Antimicrobial matrix, a new wound dressing, on diabetic foot ulcers. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Foot Ulcer
- What is being tested?
- Collagen ORC Antimicrobial Matrix (CAM)
- Type of treatment
- Medical device
- How many people
- 48 participants
- Where
- 3 sitesUnited States
- Study dates
- Jul 2004to Dec 2005
- 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
- Adult, Older adult
Who may be able to join
- 18 years of age or older.
- Ambulatory (i.e. walking is the primary method of mobilization. Crutches, walker, walking frame or other ambulation aids are permitted).
- Diagnosed Type 2 diabetic (i.e. not juvenile onset).
- Have a DFU on the plantar surface of either foot.
- Have a DFU of >4 wks but <6 months duration.
- Willing and capable of cooperating to the extent and degree required by the study protocol
Who cannot join
- Be < 1cm2 or >10cm2 in area, by planimetry.
- Demonstrate overt signs of infection.
- Be located on the dorsal, lateral, or posterior heel area of the foot (Change 2, Amendment 1).
- Have visible exposed bone or tendon.
- Have an adjacent thermal injury or wound of an etiology other than diabetes.
- Be within 5 cm of any other wound, regardless of etiology.
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- Have received enzymatic debriding agents in the past 7 days.
- Have received topical antibiotic therapy in the past 7 days.
- Be less than 1 cm2 or exceed 10cm2 in area by planimetry, after debridement.
- Have exposed bone or tendon, after debridement
- The study subject MUST NOT:
- Have received previous treatment for the study ulcer by this Investigator.
- Have more than 3 full thickness ulcers, in total.
- Be pregnant or nursing an infant
- Have a concurrent illness or condition which may interfere with wound healing, such as carcinoma, vasculitis, immune system disorders or connective tissue disorder.
- Be a known alcohol or drug abuser.
- Have received systemic corticosteroids, immunosuppressive or chemotherapeutic agents in the past 30 days.
- Have received radiotherapy, which includes the lower extremity, at any time.
- Have a marked Charcot foot or claw foot deformity which would limit the ability of the subject to wear or be compliant with the wearing of the standardized off-loading device used in this study.
- Have received an investigational drug or device in the past 30 days.
- Have a known hypersensitivity to bovine collagen, oxidized regenerated cellulose (ORC) or silver.
- Be unwilling or unable to be fitted or compliant with the wearing of an ulcer off-loading device.
- Known to be non-compliant or unlikely to complete the study.
- Have ABPI < 0.7, OR, if ABPI >1.0 and toe pressure >0.6.
- Have serum Creatinine > 3 mg/dL25. have Hgb A1C>9%
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Wound Care Center
Fort Lauderdale, Florida
Foot and Ankle Institute of South Florida
South Miami, Florida
Penn North Centers for Advanced Wound Care
Warren, Pennsylvania, 16365
About this study
Official title: A Study to Evaluate the Clinical Effectiveness of a Collagen-ORC Antimicrobial Matrix in Full-Thickness, Neuropathic Diabetic Foot Ulcers
This is a randomized (1:1), prospective, open label, multicenter, comparative study to be examine the effectiveness of Collagen-ORC Antimicrobial matrix, a new wound dressing, on diabetic foot ulcers.
- Conditions
- Foot Ulcer
- Being tested
- Collagen ORC Antimicrobial Matrix (CAM)
- Medical subject headings
- Foot Ulcer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Collagen ORC Antimicrobial Matrix (CAM)Device
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical effectiveness of CAM in DFU by comparing the reduction in wound area between 2 treatment groups.
Secondary outcomes (5)
Rate of wound closure
Ease of use and adverse events
Wound odor
Quality of life
Wound characteristics
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2005 (estimated)
- Study startJul 2004
- Study completionDec 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Foot 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
- 48 participants
Sponsor and investigators
- Lead sponsor
- Ethicon, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- James Hart, MD, Study director, Ethicon, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00235196
- Sponsor's protocol ID
- 400-04-001
- Status last verified
- Oct 2006
- First submitted
- 6 Oct 2005
- Last updated
- 13 Oct 2006
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study to Evaluate the Clinical Effectiveness of a Collagen-ORC Antimicrobial Matrix in Full-Thickness, Neuropathic Diabetic Foot Ulcers
- ClinicalTrials.gov ID
- NCT00235196
- Acronym / sponsor ID
- 400-04-001
- Conditions
- Foot Ulcer
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants
- Lead sponsor
- Ethicon, Inc.Industry (pharma, biotech, devices)
- Study start
- Jul 2004
- Study completion
- Dec 2005
- First posted
- 10 Oct 2005 (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.
This is a randomized (1:1), prospective, open label, multicenter, comparative study to be examine the effectiveness of Collagen-ORC Antimicrobial matrix, a new wound dressing, on diabetic foot ulcers.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 18 years of age or older.
- Ambulatory (i.e. walking is the primary method of mobilization. Crutches, walker, walking frame or other ambulation aids are permitted).
- Diagnosed Type 2 diabetic (i.e. not juvenile onset).
- Have a DFU on the plantar surface of either foot.
- Have a DFU of >4 wks but <6 months duration.
Key exclusion criteria (25 listed)
- Be < 1cm2 or >10cm2 in area, by planimetry.
- Demonstrate overt signs of infection.
- Be located on the dorsal, lateral, or posterior heel area of the foot (Change 2, Amendment 1).
- Have visible exposed bone or tendon.
- Have an adjacent thermal injury or wound of an etiology other than diabetes.
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 |
|---|---|---|
| Collagen ORC Antimicrobial Matrix (CAM) | Device | – |
Primary outcome
Clinical effectiveness of CAM in DFU by comparing the reduction in wound area between 2 treatment groups.
5 secondary outcomes
Rate of wound closure
Ease of use and adverse events
Wound odor
Quality of life
Wound characteristics
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 13 Oct 2006.
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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.
James Hart, MD study director
Ethicon, Inc.
3 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 Collagen ORC Antimicrobial Matrix (CAM) in people with Foot Ulcer, run by Ethicon, Inc. at 3 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 6 inclusion and 25 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 13 Oct 2006. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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 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?
Clinical effectiveness of CAM in DFU by comparing the reduction in wound area between 2 treatment groups.. 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 13 Oct 2006.