NCT00485329

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
48

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Jul 2007

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 10, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 12, 2007

Completed
19 days until next milestone

Study Start

First participant enrolled

July 1, 2007

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2009

Completed
Last Updated

May 25, 2010

Status Verified

May 1, 2010

Enrollment Period

1.7 years

First QC Date

June 10, 2007

Last Update Submit

May 24, 2010

Conditions

Lower Extremity Chronic Venous Ulcers

Keywords

Chronic Wounds, Venous Ulcers, Papain, Debridement, Continuous streamingDermaStream-EnzyStream

Outcome Measures

Primary Outcomes (3)

  • To demonstrate Dermastream-Enzystream safety

    Skin irritation score

    Up to 88 days

  • To demonstrate Dermastream-Enzystream safety

    Severity and incidence of adverse events

    Up to 88 days

  • To demonstrate Dermastream-Enzystream safety

    No deterioration in clinical laboratory parameters

    5 days

Secondary Outcomes (4)

  • •Assessment of changes in wound debridement status during treatment period

    Days 1-5

  • Assessment of wound closure

    Up to 88 days

  • Assessment of wound closure

    Up to 88 days

  • Assessment of wound closure

    Up to 88 days

Study Arms (3)

Low dose papain

EXPERIMENTAL

Ratio of drug to placebo treated patients will be 4:1

Other: Papain

Medium dose papain

EXPERIMENTAL

Ratio of drug to placebo treated patients will be 4:1

Other: Papain

High dose papain

EXPERIMENTAL

Ratio of drug to placebo treated patients will be 4:1

Other: Papain

Interventions

PapainOTHER

15,000 USP U/ml

Low dose papain

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Assaf Harofe Medical Center

Zriffin, Israel, Israel

Location

Hillel Yafe Medical Center

Hadera, 38101, Israel

Location

Rambam Medical Center

Haifa, 35254, Israel

Location

MeSH Terms

Conditions

Varicose Ulcer

Interventions

Papain

Condition Hierarchy (Ancestors)

Varicose VeinsVascular DiseasesCardiovascular DiseasesLeg UlcerSkin UlcerSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Cysteine EndopeptidasesCysteine ProteasesPeptide HydrolasesHydrolasesEnzymesEnzymes and CoenzymesEndopeptidases

Study Officials

  • Arie Bass, Prof.

    Assaf Harofe Medical Center

    PRINCIPAL INVESTIGATOR

  • Sami Nitezki, Dr.

    Rambam Health Care Campus

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

June 10, 2007

First Posted

June 12, 2007

Study Start

July 1, 2007

Primary Completion

March 1, 2009

Study Completion

March 1, 2009

Last Updated

May 25, 2010

Record last verified: 2010-05

Locations

IL(3)