Venous Leg UlcerNCT00270946
Evaluation of Bilayered Cellular Matrix (OrCel) for the Treatment of Venous Ulcers
A study testing Bilayered Cellular Matrix (OrCel) in people with Venous Leg Ulcer and Venous Stasis Ulcer, run by Ortec International at 1 site in United States.
Trial summary
This study was designed to evaluate the clinical benefits and safety of OrCel in the treatment of venous ulcers. OrCel and standard care were compared to standard care alone. Standard care consisted of currently accepted compression therapy. Patients were treated for 12 weeks. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Venous Leg Ulcer, Venous Stasis Ulcer
- What is being tested?
- Bilayered Cellular Matrix (OrCel)
- Type of treatment
- Medical device
- How many people
- 130 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2002to Dec 2003
- Phase
- Interventional
- 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 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Any race, between 18 and 85 years of age
- Male or female
- Chronic venous insufficiency
- Ulcer size between 2 and 20 sq cm, inclusive
- Ulcer present for at least one month
- ABI >0.7
Who cannot join
- Decrease in wound size >35% during Screening Phase
- Infection at the ulcer site
- Uncontrolled diabetes mellitus
- Previous treatment with excluded medications
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Pivotal Study to Evaluate the Safety and Efficacy of Cryopreserved Bilayered Cellular Matrix (OrCel) for the Treatment of Venous Ulcers
This study was designed to evaluate the clinical benefits and safety of OrCel in the treatment of venous ulcers. OrCel and standard care were compared to standard care alone. Standard care consisted of currently accepted compression therapy.
Patients were treated for 12 weeks. Patients with healed ulcers were followed for an additional 12 weeks to assess durability of the healed wound.
- Conditions
- Venous Leg Ulcer, Venous Stasis Ulcer
- Being tested
- Bilayered Cellular Matrix (OrCel)
- Keywords
- Venous leg ulcer, OrCel, Compression therapy
- Medical subject headings
- Varicose Ulcer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bilayered Cellular Matrix (OrCel)Device
What is being measured
The primary outcome is the main question the study is designed to answer.
Investigator assessment of wound healing
Secondary outcomes (2)
Planimetric assessment of wound healing
Photographic assessment of wound healing
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Dec 2005 (estimated)
- Study startApr 2002
- Study completionDec 2003
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Venous Leg 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 130 participants
Sponsor and investigators
- Lead sponsor
- Ortec International
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00270946
- Sponsor's protocol ID
- 100-VLU-01-CLN
- Status last verified
- Dec 2005
- First submitted
- 28 Dec 2005
- Last updated
- 29 Dec 2005
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Dec 2005. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pivotal Study to Evaluate the Safety and Efficacy of Cryopreserved Bilayered Cellular Matrix (OrCel) for the Treatment of Venous Ulcers
- ClinicalTrials.gov ID
- NCT00270946
- Acronym / sponsor ID
- 100-VLU-01-CLN
- Conditions
- Venous Leg Ulcer, Venous Stasis Ulcer
- Keywords
- Venous leg ulcer, OrCel, Compression therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 130 participants
- Lead sponsor
- Ortec InternationalIndustry (pharma, biotech, devices)
- Study start
- Apr 2002
- Study completion
- Dec 2003
- First posted
- 29 Dec 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 study was designed to evaluate the clinical benefits and safety of OrCel in the treatment of venous ulcers. OrCel and standard care were compared to standard care alone. Standard care consisted of currently accepted compression therapy.
Patients were treated for 12 weeks. Patients with healed ulcers were followed for an additional 12 weeks to assess durability of the healed wound.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Any race, between 18 and 85 years of age
- Male or female
- Chronic venous insufficiency
- Ulcer size between 2 and 20 sq cm, inclusive
- Ulcer present for at least one month
Key exclusion criteria (4 listed)
- Decrease in wound size >35% during Screening Phase
- Infection at the ulcer site
- Uncontrolled diabetes mellitus
- Previous treatment with excluded medications
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 |
|---|---|---|
| Bilayered Cellular Matrix (OrCel) | Device | – |
Primary outcome
Investigator assessment of wound healing
2 secondary outcomes
Planimetric assessment of wound healing
Photographic assessment of wound healing
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 29 Dec 2005.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bilayered Cellular Matrix (OrCel) in people with Venous Leg Ulcer and Venous Stasis Ulcer, run by Ortec International 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 4 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 29 Dec 2005. 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.
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?
Investigator assessment of wound healing. 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 29 Dec 2005.