Venous Stasis UlcersPhase 1NCT00823446
Feasibility Study to Evaluate the Safety of Topically Applied Revera in Subjects With Venous Leg Ulcers
A Phase 1 study testing Revera Wound Care and Normal Saline in people with Venous Stasis Ulcers, run by Revalesio Corporation at 1 site in United States.
Trial summary
The purpose of this study is to perform a preliminary evaluation of the safety of Revera Wound Care when topically applied to venous leg ulcers for 8 weeks of treatment. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Venous Stasis Ulcers
- What is being tested?
- Revera Wound Care and Normal Saline
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 13 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2008to Oct 2010
- Phase
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 years of age or older.
- Diagnosis of non-healing venous leg ulcer by the following criteria:
- dependent peripheral edema, dermatitis, hyperpigmentation.
- an ankle to arm arterial pressure ratio > 0.7 as measured by arterial Doppler.
- Venous Stasis Ulcer is ≥ 2 cm² in size.
- If female subject of reproductive age, have had a negative pregnancy test within one week of study entry and are using adequate birth control.
Who cannot join
- Subject known to be allergic to Aquacel dressing or components.
- Peripheral arterial insufficiency (as determined by Doppler ABI), uncontrolled congestive heart failure (CHF), vasculitis, uncontrolled diabetes mellitus.
- Severe contact dermatitis (allowable if it does not interfere with application of the dressings).
- Concomitantly receiving systemic corticosteroids in doses exceeding 20 mg per day.
- Involvement in another experimental drug trial within the last month.
- Clinical evidence of cellulitis or infection in or around the ulcer.
- History of non-compliance to medical regimens and is not considered reliable.
- Unable to understand the study evaluations and provide a written informed consent.
Trial locations and contacts
1 site in 1 country.
United States1 site
Roger Williams Medical Center
Providence, Rhode Island, 02908
About this study
Official title: A Feasibility, Double Blind, Randomized, Controlled Clinical Study to Evaluate the Safety of Topically Applied Revera vs. Control in Subjects With Venous Leg Ulcers.
The purpose of this study is to perform a preliminary evaluation of the safety of Revera Wound Care when topically applied to venous leg ulcers for 8 weeks of treatment.
Read the detailed description
The purpose of this study is to perform a preliminary evaluation of the safety of Revera Wound Care when topically applied to venous leg ulcers for 8 weeks of treatment.
This evaluation will be done through tabulations of adverse events (AE), review of complete blood counts (CBC) with differential and platelet, and measuring wound healing rate.
The secondary purpose of the study is a preliminary evaluation of an increase in the healing rate of venous leg ulcers treated with Revera Wound Care.
This evaluation will be done through measuring wound healing rate (which is also being used to evaluate safety) and complete wound healing.
- Conditions
- Venous Stasis Ulcers
- Being tested
- Revera Wound Care, Normal Saline
- Medical subject headings
- Varicose Ulcer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Revera Wound CareDevice
Revalesio Part Number MDW0060
Normal SalineDevice
Sodium Chloride for Irrigation
| Study group | Role | What they receive |
|---|---|---|
| Revera Wound Care | Experimental | Not described Receives: Device: Revera Wound Care |
| Normal Saline | Placebo comparator | Not described Receives: Device: Normal Saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tabulations of AEs (Adverse Event), review of CBC (Complete Blood Count) with differential and platelet.
Measured: CBC at initial screening and completion of dose regiment (8 weeks). AE's evaluated per protocol if and when they occur.
Secondary outcomes (2)
Wound edge healing rate
Measured: Weekly
Complete Wound Closure
Measured: Weekly
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jan 2009 (estimated)
- Study startMar 2008
- Primary completionOct 2010
- Study completionOct 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
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- Revalesio Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00823446
- Sponsor's protocol ID
- RC 03.1.1.HS1
- Status last verified
- Jun 2012
- First submitted
- 13 Jan 2009
- Last updated
- 26 Jun 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Feasibility, Double Blind, Randomized, Controlled Clinical Study to Evaluate the Safety of Topically Applied Revera vs. Control in Subjects With Venous Leg Ulcers.
- ClinicalTrials.gov ID
- NCT00823446
- Acronym / sponsor ID
- RC 03.1.1.HS1
- Conditions
- Venous Stasis Ulcers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- Revalesio CorporationIndustry (pharma, biotech, devices)
- Study start
- Mar 2008
- Primary completion
- Oct 2010 (actual)
- Study completion
- Oct 2010 (actual)
- First posted
- 15 Jan 2009 (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 purpose of this study is to perform a preliminary evaluation of the safety of Revera Wound Care when topically applied to venous leg ulcers for 8 weeks of treatment.
Detailed description
The purpose of this study is to perform a preliminary evaluation of the safety of Revera Wound Care when topically applied to venous leg ulcers for 8 weeks of treatment.
This evaluation will be done through tabulations of adverse events (AE), review of complete blood counts (CBC) with differential and platelet, and measuring wound healing rate.
The secondary purpose of the study is a preliminary evaluation of an increase in the healing rate of venous leg ulcers treated with Revera Wound Care.
This evaluation will be done through measuring wound healing rate (which is also being used to evaluate safety) and complete wound healing.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Revera Wound Care | Experimental | Device: Revera Wound Care |
| Normal Saline | Placebo comparator | Device: Normal Saline |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 18 years of age or older.
- Diagnosis of non-healing venous leg ulcer by the following criteria:
- Venous Stasis Ulcer is ≥ 2 cm² in size.
- If female subject of reproductive age, have had a negative pregnancy test within one week of study entry and are using adequate birth control.
Key exclusion criteria (8 listed)
- Subject known to be allergic to Aquacel dressing or components.
- Peripheral arterial insufficiency (as determined by Doppler ABI), uncontrolled congestive heart failure (CHF), vasculitis, uncontrolled diabetes mellitus.
- Severe contact dermatitis (allowable if it does not interfere with application of the dressings).
- Concomitantly receiving systemic corticosteroids in doses exceeding 20 mg per day.
- Involvement in another experimental drug trial within the last month.
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 |
|---|---|---|
| Revera Wound CareRevalesio Part Number MDW0060 | Device | Revera Wound Care |
| Normal SalineSodium Chloride for Irrigation | Device | Normal Saline |
Primary outcome
Tabulations of AEs (Adverse Event), review of CBC (Complete Blood Count) with differential and platelet.
Time frame: CBC at initial screening and completion of dose regiment (8 weeks). AE's evaluated per protocol if and when they occur.
2 secondary outcomes
Wound edge healing rate
Time frame: Weekly
Complete Wound Closure
Time frame: Weekly
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 26 Jun 2012.
Related trials for Venous Stasis Ulcers
Recruiting
PAW-Hydrogel for Chronic Wound Healing
Diabetic Foot Ulcer (DFU), Pressure Ulcer (PU)
Recruiting
Vacuum Compression Therapy and Tissue Oxygenation in Chronic Leg Ulcers
Leg Ulcers, Leg Ulcers Venous
Recruiting
Dose-Response Structured Calf Muscle Pump Activation Strategies Versus Unsupervised Home Walks
Venous Ulcer of Leg
RecruitingPhase 4
Topical Sevoflurane for Treatment of Chronic Leg Ulcers
Leg Ulcer
Recruiting
The GORE® VIABAHN® FORTEGRA Venous Stent Post-Approval Study
Venous Thromboses, Venous Disease
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 Phase 1 study testing Revera Wound Care and Normal Saline in people with Venous Stasis Ulcers, run by Revalesio Corporation 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 8 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 26 Jun 2012. 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. Some participants in this study may receive a placebo. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Tabulations of AEs (Adverse Event), review of CBC (Complete Blood Count) with differential and platelet. (time frame: CBC at initial screening and completion of dose regiment (8 weeks). AE's evaluated per protocol if and when they occur.). 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 26 Jun 2012.