Venous InsufficiencyPhase 1/2NCT00310752
Evaluation of DermStream(tm) - an Irrigation Product for Chronic Wound Management
A Phase 1/2 study testing DermaStream(tm) application and Streaming of Saline in people with Venous Insufficiency and Diabetes, run by EnzySurge at 1 site in Israel.
Trial summary
The primary purpose of this study is to evaluate the safety of DermaStream(tm) in the management of chronic wounds. Other goals of this study are to gain feedback from patients and healthcare providers on the ease of use (the ergonomic aspect) of the device, and to make a preliminary evaluation of the efficacy of… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Venous Insufficiency, Diabetes
- What is being tested?
- DermaStream(tm) application and Streaming of Saline
- Type of treatment
- Medical device
- How many people
- 11 participants
- Where
- 1 siteIsrael
- Study dates
- Mar 2006to Dec 2006
- Phase
- Phase 1/2
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diabetic ulcer, OR Venous insufficiency ulcer
- Age range: 18-80 years
- Wound max. diameter range: 1.5 - 10 centimeters
- Wound San Antonio assessment system: grade 1 and 2, stage A and B
- Palpable pulses in the Posterior Tibial and the Dorsalis Pedis arteries
- Ankle-Brachial Index > 0.7 by Doppler
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- Wound present for at least 6 weeks
- Wound location: foot or calf, at a location where the device can be attached properly
- Lack of purulent discharge from the wound.
Who cannot join
- Hypoalbuminemia: Albumin < 2gr/dl
- Right-side congestive heart failure with edema of legs: +2 or higher
- Renal insufficiency: Cr > 2 mg/dl
- Abnormal liver function: ALT or AST>300
- Skin disorders adjacent to the wound, unrelated to the pathology of the wound
- Non-cooperative patient
Trial locations and contacts
1 site in 1 country.
About this study
The primary purpose of this study is to evaluate the safety of DermaStream(tm) in the management of chronic wounds.
Other goals of this study are to gain feedback from patients and healthcare providers on the ease of use (the ergonomic aspect) of the device, and to make a preliminary evaluation of the efficacy of DermaStream(tm) in chronic wound management.
Read the detailed description
Until now no expected or unexpected adverse events were occurred
- Conditions
- Venous Insufficiency, Diabetes
- Being tested
- DermaStream(tm) application and Streaming of Saline
- Medical subject headings
- Venous Insufficiency, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DermaStream(tm) application and Streaming of SalineDevice
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2006 (estimated)
- Study startMar 2006
- Primary completionDec 2006
- Study completionDec 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Venous InsufficiencyStudies 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 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- EnzySurge
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Arie Bass, Prof., Principal investigator, Asaf Harofe Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00310752
- Sponsor's protocol ID
- DS-1
- Status last verified
- Jul 2008
- First submitted
- 3 Apr 2006
- Last updated
- 1 Aug 2008
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of DermStream(tm) - an Irrigation Product for Chronic Wound Management
- ClinicalTrials.gov ID
- NCT00310752
- Acronym / sponsor ID
- DS-1
- Conditions
- Venous Insufficiency, Diabetes
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- EnzySurgeIndustry (pharma, biotech, devices)
- Study start
- Mar 2006
- Primary completion
- Dec 2006 (actual)
- Study completion
- Dec 2006 (actual)
- First posted
- 4 Apr 2006 (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 primary purpose of this study is to evaluate the safety of DermaStream(tm) in the management of chronic wounds.
Other goals of this study are to gain feedback from patients and healthcare providers on the ease of use (the ergonomic aspect) of the device, and to make a preliminary evaluation of the efficacy of DermaStream(tm) in chronic wound management.
Detailed description
Until now no expected or unexpected adverse events were occurred
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Diabetic ulcer, OR Venous insufficiency ulcer
- Age range: 18-80 years
- Wound max. diameter range: 1.5 - 10 centimeters
- Wound San Antonio assessment system: grade 1 and 2, stage A and B
- Palpable pulses in the Posterior Tibial and the Dorsalis Pedis arteries
Key exclusion criteria (6 listed)
- Hypoalbuminemia: Albumin < 2gr/dl
- Right-side congestive heart failure with edema of legs: +2 or higher
- Renal insufficiency: Cr > 2 mg/dl
- Abnormal liver function: ALT or AST>300
- Skin disorders adjacent to the wound, unrelated to the pathology of the wound
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 |
|---|---|---|
| DermaStream(tm) application and Streaming of Saline | Device | – |
Primary outcome
Not reported in the source record.
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 1 Aug 2008.
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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.
Arie Bass, Prof. principal investigator
Asaf Harofe Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing DermaStream(tm) application and Streaming of Saline in people with Venous Insufficiency and Diabetes, run by EnzySurge at 1 site in Israel.
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: finished, as of the sponsor's last update on 1 Aug 2008. 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 Israel. 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 combined 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.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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.
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 1 Aug 2008; AzTrials last refreshed its copy on 7 Nov 2026.