Back to results

Assessment of the Safety and Efficacy of DERMASTREAM™ - ENZYSTREAM™ System for the Treatment of Chronic Venous Ulcers (ENZ-DER-002-IL)

Primary Purpose

Lower Extremity Chronic Venous Ulcers

Status

Completed

Phase

Phase 1

Locations

Israel

Study Type

Interventional

Intervention

Papain

About this trial

This is an interventional treatment trial for Lower Extremity Chronic Venous Ulcers focused on measuring Chronic Wounds, Venous Ulcers, Papain, Debridement, Continuous streaming, DermaStream-EnzyStream

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Hillel Yafe Medical Center
Rambam Medical Center
Assaf Harofe Medical Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Arm Label

Low dose papain

Medium dose papain

High dose papain

Arm Description

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

Outcomes

Primary Outcome Measures

To demonstrate Dermastream-Enzystream safety

Skin irritation score

To demonstrate Dermastream-Enzystream safety

Severity and incidence of adverse events

To demonstrate Dermastream-Enzystream safety

No deterioration in clinical laboratory parameters

Secondary Outcome Measures

•Assessment of changes in wound debridement status during treatment period

Change in non viable tissue area

Assessment of wound closure

Reduction of nonviable tissue area

Assessment of wound closure

Increase of granulation tissue area

Assessment of wound closure

Time (in days) for wound closure

Full Information

NCT ID

NCT00485329

First Posted

June 10, 2007

Last Updated

May 24, 2010

Sponsor

EnzySurge

1. Study Identification

Unique Protocol Identification Number

NCT00485329

Brief Title

Assessment of the Safety and Efficacy of DERMASTREAM™ - ENZYSTREAM™ System for the Treatment of Chronic Venous Ulcers

Acronym

ENZ-DER-002-IL

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

Study Type

Interventional

2. Study Status

Record Verification Date

May 2010

Overall Recruitment Status

Completed

Study Start Date

July 2007 (undefined)

Primary Completion Date

March 2009 (Actual)

Study Completion Date

March 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

EnzySurge

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Lower Extremity Chronic Venous Ulcers

Keywords

Chronic Wounds, Venous Ulcers, Papain, Debridement, Continuous streaming, DermaStream-EnzyStream

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1, Phase 2

Interventional Study Model

Parallel Assignment

Masking

Double

Allocation

Randomized

Enrollment

48 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Low dose papain

Arm Type

Experimental

Arm Description

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

Arm Title

Medium dose papain

Arm Type

Experimental

Arm Description

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

Arm Title

High dose papain

Arm Type

Experimental

Arm Description

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

Intervention Type

Other

Intervention Name(s)

Papain

Intervention Description

15,000 USP U/ml

Intervention Type

Other

Intervention Name(s)

Papain

Intervention Description

30,000 USP U/ml

Intervention Type

Other

Intervention Name(s)

Papain

Intervention Description

60,000 USP U/ml

Primary Outcome Measure Information:

Title

To demonstrate Dermastream-Enzystream safety

Description

Skin irritation score

Time Frame

Up to 88 days

Title

To demonstrate Dermastream-Enzystream safety

Description

Severity and incidence of adverse events

Time Frame

Up to 88 days

Title

To demonstrate Dermastream-Enzystream safety

Description

No deterioration in clinical laboratory parameters

Time Frame

5 days

Secondary Outcome Measure Information:

Title

•Assessment of changes in wound debridement status during treatment period

Description

Change in non viable tissue area

Time Frame

Days 1-5

Title

Assessment of wound closure

Description

Reduction of nonviable tissue area

Time Frame

Up to 88 days

Title

Assessment of wound closure

Description

Increase of granulation tissue area

Time Frame

Up to 88 days

Title

Assessment of wound closure

Description

Time (in days) for wound closure

Time Frame

Up to 88 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

85 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Arie Bass, Prof.

Organizational Affiliation

Assaf Harofe Medical Center

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Sami Nitezki, Dr.

Organizational Affiliation

Rambam Health Care Campus

Official's Role

Principal Investigator

Facility Information:

Facility Name

Hillel Yafe Medical Center

City

Hadera

ZIP/Postal Code

38101

Country

Israel

Facility Name

Rambam Medical Center

City

Haifa

ZIP/Postal Code

35254

Country

Israel

Facility Name

Assaf Harofe Medical Center

City

Zriffin

Country

Israel

12. IPD Sharing Statement

Links:

URL

http://www.Enzysurge.com

Description

Related Info

Learn more about this trial

Assessment of the Safety and Efficacy of DERMASTREAM™ - ENZYSTREAM™ System for the Treatment of Chronic Venous Ulcers

We'll reach out to this number within 24 hrs