Venous Stasis UlcersNCT01129986
A Post Marketing Clinical Study Utilizing DermaStream and Saline in Venous Ulcers
A study testing DermaStream in people with Venous Stasis Ulcers, run by EnzySurge at 1 site in United States.
Trial summary
An open-label, prospective, controlled, two-step approach, post-marketing clinical study, applying DermaStream with saline streaming, in conjunction with a sustained multi-compression wrap, on healthy individuals and on patients with a venous stasis ulcer of the lower extremity. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Venous Stasis Ulcers
- What is being tested?
- DermaStream
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2009to Nov 2011
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Group A:
- Must be male or female ≥18 years of age.
- Must be a healthy individual with intact skin
- Group B:
- Must be male or female ≥18 years of age
- Must have a venous stasis ulcer between the knee and the ankle (including the lateral and medial malleolus). The ulcer must have the typical appearance of venous leg ulceration and the diagnosis of venous origin.
- Ankle Brachial Pressure Index of >0.8 -<=1.2
- Must have a venous leg ulcer between 3 cm up to 5.6 cm maximum and an ulcer duration of 60 days or greater prior to enrollment in the study
Who cannot join
- Group A and Group B:
- Is unable to manage the self-treatment at home
- Is pregnant or is a nursing mother
- Is a woman of child bearing potential who is not using an adequate form of contraception (or abstinent)
- Is < 18 years of age
- With gross morbid obesity (i.e., a Body Mass Index ≥ 50)
Show all 24Show fewer
- Has a known allergy to any of the drugs and/or dressings that are part of this protocol
- Has previously participated in this study
- Group B:
- Has an ulcer that is deemed by the Investigator to be caused primarily by a medical condition other than venous insufficiency (e.g., diabetes, malignant ulceration [Marjolin's ulcer], vasculitis, etc.)
- Has evidence of current clinical infection although colonization is not an exclusion criterion (see definition section)
- Suffers from diabetes mellitus with HbA1c ≥ 10%
- Suffers from clinically significant arterial disease
- Has evidence of the ulcer and/or infection extending to the underlying muscle, tendon, or bone
- Has used any investigational drug(s)/device(s) within 30 days preceding screening or the physician or subject anticipates use of any of these treatments during the 2 weeks following start of the treatment portion of the study
- Has used or is anticipated to use any of the prohibited concomitant medications and treatments, as specified in study protocol, section 9.1.
- Suffers from a condition, other than venous insufficiency or venous hypertension which, in the opinion of the Investigator, would compromise the safety of the subject and/or the quality of the data.
- Suffers from a condition, other than venous insufficiency or venous hypertension which, in the opinion of the Investigator, would seriously interfere negatively with the normal wound healing process.
- Has laboratory values at screening outside ± 20% of the institution's normal range for any parameter other than HbA1c
- If laboratory values are outside ± 20% but the investigator deems the subject acceptable for enrollment, the Principal Investigator may approve the inclusion of the subject as long as there is no evidence of any comorbid condition where comorbidity could influence the trialIs using any of the prohibited concomitant medications or treatments.
- Wound surrounding skin not intact or has signs of active dermatitis or infection
- Wound over-bleeds
- Wound is severely ischemic
- Wound is larger than device aperture diameter
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Post Marketing Clinical Study Utilizing DermaStream and Saline for Safety and Efficacy in Venous Stasis Ulcers of the Lower Extremity
An open-label, prospective, controlled, two-step approach, post-marketing clinical study, applying DermaStream with saline streaming, in conjunction with a sustained multi-compression wrap, on healthy individuals and on patients with a venous stasis ulcer of the lower extremity.
- Conditions
- Venous Stasis Ulcers
- Being tested
- DermaStream
- Keywords
- venous ulcer Dermastream
- Medical subject headings
- Varicose Ulcer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DermaStreamDevice
Five treatment days. On each day DermaStream application for up to 4 hours of saline streaming.
| Study group | Role | What they receive |
|---|---|---|
| Dermastream | Experimental | Not described Receives: Device: DermaStream |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effect of DermaStream application
Reduction of slough tissue.
Measured: Up to 21 days
Adverse Events
Incidence of investigational product related adverse events
Measured: Up to 21 days
Effect of DermaStream application
Increase of granulation tissue
Measured: Up to 21 days
Effect of DermaStream application
Pain recording on 1-10 scale
Measured: Up to 21 days
Secondary outcomes (3)
Usability
Device malfunction reports and device replacements as measures of usability
Measured: 1-5 days
Wound size
Decrease in wound size at 2 weeks following last treatment day
Measured: Up to 21 days
Quality of Life
Improved "Quality of Life" at 2 weeks following last treatment day
Measured: Up to 21 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2010 (estimated)
- Study startJun 2009
- Primary completionJul 2010
- Study completionNov 2011
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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- EnzySurge
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Daniel Ihnat, Principal investigator, S.A.L.S.A, Tucson Arizona
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01129986
- Sponsor's protocol ID
- ENZ-DER-003-US
- Status last verified
- Jun 2011
- First submitted
- 10 May 2010
- Last updated
- 4 Sep 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Post Marketing Clinical Study Utilizing DermaStream and Saline for Safety and Efficacy in Venous Stasis Ulcers of the Lower Extremity
- ClinicalTrials.gov ID
- NCT01129986
- Acronym / sponsor ID
- ENZ-DER-003-US
- Conditions
- Venous Stasis Ulcers
- Keywords
- venous ulcer Dermastream
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- EnzySurgeIndustry (pharma, biotech, devices)
- Study start
- Jun 2009
- Primary completion
- Jul 2010 (actual)
- Study completion
- Nov 2011 (actual)
- First posted
- 25 May 2010 (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.
An open-label, prospective, controlled, two-step approach, post-marketing clinical study, applying DermaStream with saline streaming, in conjunction with a sustained multi-compression wrap, on healthy individuals and on patients with a venous stasis ulcer of the lower extremity.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Dermastream | Experimental | Device: DermaStream |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Must be male or female ≥18 years of age.
- Must be a healthy individual with intact skin
- Must be male or female ≥18 years of age
- Must have a venous stasis ulcer between the knee and the ankle (including the lateral and medial malleolus). The ulcer must have the typical appearance of venous leg ulceration and the diagnosis of venous origin.
- Ankle Brachial Pressure Index of >0.8 -<=1.2
Key exclusion criteria (24 listed)
- Is unable to manage the self-treatment at home
- Is pregnant or is a nursing mother
- Is a woman of child bearing potential who is not using an adequate form of contraception (or abstinent)
- Is < 18 years of age
- With gross morbid obesity (i.e., a Body Mass Index ≥ 50)
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 |
|---|---|---|
| DermaStreamFive treatment days. On each day DermaStream application for up to 4 hours of saline streaming. | Device | Dermastream |
Primary outcome
Effect of DermaStream application
Time frame: Up to 21 days
Reduction of slough tissue.
Adverse Events
Time frame: Up to 21 days
Incidence of investigational product related adverse events
Effect of DermaStream application
Time frame: Up to 21 days
Increase of granulation tissue
Effect of DermaStream application
Time frame: Up to 21 days
Pain recording on 1-10 scale
3 secondary outcomes
Usability
Time frame: 1-5 days
Wound size
Time frame: Up to 21 days
Quality of Life
Time frame: Up to 21 days
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 4 Sep 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.
Daniel Ihnat principal investigator
S.A.L.S.A, Tucson Arizona
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing DermaStream in people with Venous Stasis Ulcers, run by EnzySurge 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 8 inclusion and 24 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 4 Sep 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.
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?
Effect of DermaStream application (time frame: Up to 21 days). The study lists 4 primary outcomes in all. 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 4 Sep 2013.