- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00485329
Assessment of the Safety and Efficacy of DERMASTREAM™ - ENZYSTREAM™ System for the Treatment of Chronic Venous Ulcers (ENZ-DER-002-IL)
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
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Phase 2
- Phase 1
Contacts and Locations
Study Locations
-
-
-
Hadera, Israel, 38101
- Hillel Yafe Medical Center
-
Haifa, Israel, 35254
- Rambam Medical Center
-
Zriffin, Israel
- Assaf Harofe Medical Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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.
- 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.
Exclusion Criteria:
- 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).
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Low dose papain
Ratio of drug to placebo treated patients will be 4:1
|
15,000 USP U/ml
30,000 USP U/ml
60,000 USP U/ml
|
Experimental: Medium dose papain
Ratio of drug to placebo treated patients will be 4:1
|
15,000 USP U/ml
30,000 USP U/ml
60,000 USP U/ml
|
Experimental: High dose papain
Ratio of drug to placebo treated patients will be 4:1
|
15,000 USP U/ml
30,000 USP U/ml
60,000 USP U/ml
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
To demonstrate Dermastream-Enzystream safety
Time Frame: Up to 88 days
|
Skin irritation score
|
Up to 88 days
|
To demonstrate Dermastream-Enzystream safety
Time Frame: Up to 88 days
|
Severity and incidence of adverse events
|
Up to 88 days
|
To demonstrate Dermastream-Enzystream safety
Time Frame: 5 days
|
No deterioration in clinical laboratory parameters
|
5 days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
•Assessment of changes in wound debridement status during treatment period
Time Frame: Days 1-5
|
Change in non viable tissue area
|
Days 1-5
|
Assessment of wound closure
Time Frame: Up to 88 days
|
Reduction of nonviable tissue area
|
Up to 88 days
|
Assessment of wound closure
Time Frame: Up to 88 days
|
Increase of granulation tissue area
|
Up to 88 days
|
Assessment of wound closure
Time Frame: Up to 88 days
|
Time (in days) for wound closure
|
Up to 88 days
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Arie Bass, Prof., Assaf Harofe Medical Center
- Principal Investigator: Sami Nitezki, Dr., Rambam Health Care Campus
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- ENZ-DER-002-IL
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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