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Assessment of the Safety and Efficacy of DERMASTREAM™ - ENZYSTREAM™ System for the Treatment of Chronic Venous Ulcers (ENZ-DER-002-IL)
This study is not yet open for participant recruitment.
Verified by EnzySurge, June 2007
First Received: June 10, 2007   Last Updated: June 11, 2007   History of Changes
Sponsored by: EnzySurge
Information provided by: EnzySurge
ClinicalTrials.gov Identifier: NCT00485329
  Purpose

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.


Condition Intervention Phase
Lower Extremity Chronic Venous Ulcers
 Drug: Papain
Device: DermaStream™ - EnzyStream™ System
 Phase I
Phase II

Drug Information available for: Papain
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy 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

Further study details as provided by EnzySurge:

Primary Outcome Measures:
  • Safety evaluation - To demonstrate Dermastream-Enzystream safety in terms of: Skin irritation score, Severity of adverse events, No deterioration in clinical laboratory parameters. [ Time Frame: At study end ]

Secondary Outcome Measures:
  • •Assessment of changes in wound debridement status •Evaluation of treatment period to changes in wound debridement status. •Assessment and time for "Readiness for skin graft" status •Assessment of wound closure state [ Time Frame: At study end ]

Estimated Enrollment: 48
Study Start Date: July 2007
Estimated Study Completion Date: February 2009
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).

  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Patient must have a venous leg ulcer
  2. Participants, either men or women are between 18 and 85 years of age.
  3. Clinical presentation of venous insufficiency demonstrated by Doppler
  4. Ankle-Brachial Index > 0.7 by Doppler
  5. Good palpable pulses in the Posterior Tibial and the Dorsalis Pedis arteries.
  6. Wound present for at least 6 weeks prior to enrolment.
  7. Wound length is in the range of: 1.5 – 7 centimeters.
  8. The necrotic tissue area is at least 20% of wound area. (by clinical evaluation, i.e., inspection).
  9. Wound San Antonio classification: Grade 1 or 2, Stage A or B.
  10. Wound location: foot or calf, at a location where the device can be attached properly.
  11. Participant understands the nature of the procedure and provides written informed consent prior to any study procedure.
  12. Women of child bearing potential must use adequate birth-control precautions.

Exclusion Criteria:

  1. Documented sensitivity to Papain, by medical history records.
  2. Patients in need of surgical debridement.
  3. Patients with general skin disorders (Psoriasis, Peniculitis ect) that might deteriorate as a result of local trauma.
  4. Patients with skin disorders unrelated to the ulcer that are presented adjacent to the wound.
  5. Pain sensation is completely absent (wound area is anesthetic).
  6. Patients with renal failure. (Cr > 2 mg/dl).
  7. Patients with impaired hepatic function (ALT, AST or GGT 2-fold higher than normal upper limit value).
  8. Patients having Hypoalbuminemia: (Albumin < 2gr/dl ).
  9. Patients with general Immunological disorders that might deteriorate as a result of local trauma.
  10. Right-side congestive heart failure (CHF) with edema of legs: (NYHA class 2 or higher see APPENDIX 5).
  11. Participation in another clinical trial within 1 month prior to start of this study.
  12. Subject unwilling or unable to comply with the requirements of the protocol
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00485329

Contacts
Contact: Arie Bass, Prof. +972(8)9779188 arbas@post.tau.ac.il

Locations
Israel
Rambam Medical Center
Haifa, Israel, 35254
Hillel Yafe Medical Center
Hadera, Israel, 38101
Sponsors and Collaborators
EnzySurge
Investigators
Principal Investigator: Arie Bass, Prof. Assaf Harofe Medical Center
Principal Investigator: Sami Nitezki, Dr. Rambam Health Care Campus
Principal Investigator: Isaac Portnoi, Dr. Hillel Yafe Medical Center
  More Information

Additional Information:
Related Info  This link exits the ClinicalTrials.gov site

No publications provided

Study ID Numbers: ENZ-DER-002-IL
Study First Received: June 10, 2007
Last Updated: June 11, 2007
ClinicalTrials.gov Identifier: NCT00485329     History of Changes
Health Authority: Israel: MOH

Keywords provided by EnzySurge:
Chronic Wounds, Venous Ulcers, Papain, Debridement

Study placed in the following topic categories:
Varicose Ulcer
Skin Diseases
Varicose Veins
Ulcer
 Vascular Diseases
Skin Ulcer
Leg Ulcer

Additional relevant MeSH terms:
Varicose Ulcer
Pathologic Processes
Skin Diseases
Varicose Veins
Ulcer
 Vascular Diseases
Cardiovascular Diseases
Skin Ulcer
Leg Ulcer

ClinicalTrials.gov processed this record on May 07, 2009



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