Lower Extremity Chronic Venous UlcersPhase 1/2ENZ-DER-002-ILNCT00485329
Assessment of the Safety and Efficacy of DERMASTREAM™ - ENZYSTREAM™ System for the Treatment of Chronic Venous Ulcers
A Phase 1/2 study testing Papain in people with Lower Extremity Chronic Venous Ulcers, run by EnzySurge at 3 sites in Israel.
Trial summary
The study objectives are to evaluate DermastreamTM - EnzystreamTM system safety, tolerability and efficacy, as a potent method for debridement of nonhealing lower extremity chronic venous ulcers patients. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Lower Extremity Chronic Venous Ulcers
- What is being tested?
- Papain
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 3 sitesIsrael
- Study dates
- Jul 2007to Mar 2009
- 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 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient must have a venous leg ulcer
- Participants, either men or women are between 18 and 85 years of age.
- Clinical presentation of venous insufficiency demonstrated by Doppler
- Ankle-Brachial Index > 0.7 by Doppler
- Good palpable pulses in the Posterior Tibial and the Dorsalis Pedis arteries.
- Wound present for at least 6 weeks prior to enrolment.
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- Wound length is in the range of: 1.5 - 7 centimeters.
- The necrotic tissue area is at least 20% of wound area. (by clinical evaluation, i.e., inspection).
- Wound San Antonio classification: Grade 1 or 2, Stage A or B.
- Wound location: foot or calf, at a location where the device can be attached properly.
- Participant understands the nature of the procedure and provides written informed consent prior to any study procedure.
- Women of child bearing potential must use adequate birth-control precautions.
Who cannot join
- Documented sensitivity to Papain, by medical history records.
- Patients in need of surgical debridement.
- Patients with general skin disorders (Psoriasis, Peniculitis ect) that might deteriorate as a result of local trauma.
- Patients with skin disorders unrelated to the ulcer that are presented adjacent to the wound.
- Pain sensation is completely absent (wound area is anesthetic).
- Patients with renal failure. (Cr > 2 mg/dl).
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- Patients with impaired hepatic function (ALT, AST or GGT 2-fold higher than normal upper limit value).
- Patients having Hypoalbuminemia: (Albumin < 2gr/dl ).
- Patients with general Immunological disorders that might deteriorate as a result of local trauma.
- Right-side congestive heart failure (CHF) with edema of legs: (NYHA class 2 or higher see APPENDIX 5).
- Participation in another clinical trial within 1 month prior to start of this study.
- Subject unwilling or unable to comply with the requirements of the protocol
Trial locations and contacts
3 sites in 1 country.
Israel3 sites
Hillel Yafe Medical Center
Hadera, 38101
Rambam Medical Center
Haifa, 35254
Assaf Harofe Medical Center
Zriffin, Israel
About this study
Official title: A Phase I/II Randomized, Double Blind, Placebo-Controlled Dose- Escalating Study, to Assess The Safety and Efficacy of Enzystream™ Debriding Solution (Papain) Applied by Dermastream™ Device for the Treatment of Lower Extremity Chronic Venous Ulcers
The study objectives are to evaluate DermastreamTM - EnzystreamTM system safety, tolerability and efficacy, as a potent method for debridement of nonhealing lower extremity chronic venous ulcers patients.
Read the detailed description
This is a phase I/II prospective, randomized, double blind, placebo controlled, dose escalating, three patient-group study, to evaluate the safety and efficacy of DermaStream™ - EnzyStream™ System in non-healing lower extremity chronic venous ulcers patients. The DermaStream™ - EnzyStream™ System will be evaluated during continues streaming of 3 different doses of EnzystreamTM (papain based) solution given in an escalating order (15,000, 30,000 and 60,000 papain USP units/ml) up to 5 consecutive treatment days. Each treatment session lasts for 6 hours. This study is a Multi center trial. It is anticipated that three (3) sites will enroll subjects into this study. Overall, forty eight (48) patients will be recruited, and randomly allocated to placebo or EnzyStream™ treatment in each study dose group prior to EnzyStream™ administration. The ratio of drug to placebo treated patients will be 4;1, namely 12 patients will be administered with EnzyStream™ solution and 4 patients will be placebo treated in each of the three respective EnzyStream™ dose groups. Treatment will start with the lowest dose (15,000 papain USP units/ml) administered over a 6 hour period followed with saline wash for an additional half an hour. The treatment dose will be increased to the next highest dose, for the next patients group only following safety analysis, and the procedure will be repeated.
The treatment period will be followed by a 3 month follow up period. During the follow up period patients will be observed for every 2 weeks during the first month and once a month (every 20 days) during the 2 additional months (allowing a time window of ± 3 days).
- Conditions
- Lower Extremity Chronic Venous Ulcers
- Being tested
- Papain
- Keywords
- Chronic Wounds, Venous Ulcers, Papain, Debridement, Continuous streaming, DermaStream-EnzyStream
- Medical subject headings
- Varicose Ulcer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PapainOther
15,000 USP U/ml
PapainOther
30,000 USP U/ml
PapainOther
60,000 USP U/ml
| Study group | Role | What they receive |
|---|---|---|
| Low dose papain | Experimental | Ratio of drug to placebo treated patients will be 4:1 Receives: Other: Papain |
| Medium dose papain | Experimental | Ratio of drug to placebo treated patients will be 4:1 Receives: Other: Papain |
| High dose papain | Experimental | Ratio of drug to placebo treated patients will be 4:1 Receives: Other: Papain |
What is being measured
The primary outcome is the main question the study is designed to answer.
To demonstrate Dermastream-Enzystream safety
Skin irritation score
Measured: Up to 88 days
To demonstrate Dermastream-Enzystream safety
Severity and incidence of adverse events
Measured: Up to 88 days
To demonstrate Dermastream-Enzystream safety
No deterioration in clinical laboratory parameters
Measured: 5 days
Secondary outcomes (4)
•Assessment of changes in wound debridement status during treatment period
Change in non viable tissue area
Measured: Days 1-5
Assessment of wound closure
Reduction of nonviable tissue area
Measured: Up to 88 days
Assessment of wound closure
Increase of granulation tissue area
Measured: Up to 88 days
Assessment of wound closure
Time (in days) for wound closure
Measured: Up to 88 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2007 (estimated)
- Study startJul 2007
- Primary completionMar 2009
- Study completionMar 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lower Extremity Chronic Venous 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- EnzySurge
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Arie Bass, Prof., Principal investigator, Assaf Harofe Medical CenterSami Nitezki, Dr., Principal investigator, Rambam Health Care Campus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00485329
- Sponsor's protocol ID
- ENZ-DER-002-IL
- Acronym
- ENZ-DER-002-IL
- Status last verified
- May 2010
- First submitted
- 10 Jun 2007
- Last updated
- 25 May 2010
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 25 May 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I/II Randomized, Double Blind, Placebo-Controlled Dose- Escalating Study, to Assess The Safety and Efficacy of Enzystream™ Debriding Solution (Papain) Applied by Dermastream™ Device for the Treatment of Lower Extremity Chronic Venous Ulcers
- ClinicalTrials.gov ID
- NCT00485329
- Acronym / sponsor ID
- ENZ-DER-002-IL / ENZ-DER-002-IL
- Conditions
- Lower Extremity Chronic Venous Ulcers
- Keywords
- Chronic Wounds, Venous Ulcers, Papain, Debridement, Continuous streaming, DermaStream-EnzyStream
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- EnzySurgeIndustry (pharma, biotech, devices)
- Study start
- Jul 2007
- Primary completion
- Mar 2009 (actual)
- Study completion
- Mar 2009 (actual)
- First posted
- 12 Jun 2007 (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 study objectives are to evaluate DermastreamTM - EnzystreamTM system safety, tolerability and efficacy, as a potent method for debridement of nonhealing lower extremity chronic venous ulcers patients.
Detailed description
This is a phase I/II prospective, randomized, double blind, placebo controlled, dose escalating, three patient-group study, to evaluate the safety and efficacy of DermaStream™ - EnzyStream™ System in non-healing lower extremity chronic venous ulcers patients. The DermaStream™ - EnzyStream™ System will be evaluated during continues streaming of 3 different doses of EnzystreamTM (papain based) solution given in an escalating order (15,000, 30,000 and 60,000 papain USP units/ml) up to 5 consecutive treatment days. Each treatment session lasts for 6 hours. This study is a Multi center trial. It is anticipated that three (3) sites will enroll subjects into this study. Overall, forty eight (48) patients will be recruited, and randomly allocated to placebo or EnzyStream™ treatment in each study dose group prior to EnzyStream™ administration. The ratio of drug to placebo treated patients will be 4;1, namely 12 patients will be administered with EnzyStream™ solution and 4 patients will be placebo treated in each of the three respective EnzyStream™ dose groups. Treatment will start with the lowest dose (15,000 papain USP units/ml) administered over a 6 hour period followed with saline wash for an additional half an hour. The treatment dose will be increased to the next highest dose, for the next patients group only following safety analysis, and the procedure will be repeated.
The treatment period will be followed by a 3 month follow up period. During the follow up period patients will be observed for every 2 weeks during the first month and once a month (every 20 days) during the 2 additional months (allowing a time window of ± 3 days).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Low dose papain | Experimental | Other: PapainRatio of drug to placebo treated patients will be 4:1 |
| Medium dose papain | Experimental | Other: PapainRatio of drug to placebo treated patients will be 4:1 |
| High dose papain | Experimental | Other: PapainRatio of drug to placebo treated patients will be 4:1 |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Patient must have a venous leg ulcer
- Participants, either men or women are between 18 and 85 years of age.
- Clinical presentation of venous insufficiency demonstrated by Doppler
- Ankle-Brachial Index > 0.7 by Doppler
- Good palpable pulses in the Posterior Tibial and the Dorsalis Pedis arteries.
Key exclusion criteria (12 listed)
- Documented sensitivity to Papain, by medical history records.
- Patients in need of surgical debridement.
- Patients with general skin disorders (Psoriasis, Peniculitis ect) that might deteriorate as a result of local trauma.
- Patients with skin disorders unrelated to the ulcer that are presented adjacent to the wound.
- Pain sensation is completely absent (wound area is anesthetic).
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 |
|---|---|---|
| Papain15,000 USP U/ml | Other | Low dose papain |
| Papain30,000 USP U/ml | Other | Medium dose papain |
| Papain60,000 USP U/ml | Other | High dose papain |
Primary outcome
To demonstrate Dermastream-Enzystream safety
Time frame: Up to 88 days
Skin irritation score
To demonstrate Dermastream-Enzystream safety
Time frame: Up to 88 days
Severity and incidence of adverse events
To demonstrate Dermastream-Enzystream safety
Time frame: 5 days
No deterioration in clinical laboratory parameters
4 secondary outcomes
•Assessment of changes in wound debridement status during treatment period
Time frame: Days 1-5
Assessment of wound closure
Time frame: Up to 88 days
Assessment of wound closure
Time frame: Up to 88 days
Assessment of wound closure
Time frame: Up to 88 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 25 May 2010.
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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
Assaf Harofe Medical Center
Sami Nitezki, Dr. principal investigator
Rambam Health Care Campus
3 sites 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 Papain in people with Lower Extremity Chronic Venous Ulcers, run by EnzySurge at 3 sites 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 12 inclusion and 12 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 25 May 2010. 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 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.
What does the primary outcome measure?
To demonstrate Dermastream-Enzystream safety (time frame: Up to 88 days). The study lists 3 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 25 May 2010.