Lower Extremity Chronic Venous Ulcers Clinical Trial
— ENZ-DER-002-ILOfficial 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
| Verified date | May 2010 |
| Source | EnzySurge |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | Israel: Ministry of Health - MOH |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 48 |
| Est. completion date | March 2009 |
| Est. primary completion date | March 2009 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years to 85 Years |
| Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| Israel | Hillel Yafe Medical Center | Hadera | |
| Israel | Rambam Medical Center | Haifa | |
| Israel | Assaf Harofe Medical Center | Zriffin |
| Lead Sponsor | Collaborator |
|---|---|
| EnzySurge |
Israel,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | To demonstrate Dermastream-Enzystream safety | Skin irritation score | Up to 88 days | Yes |
| Primary | To demonstrate Dermastream-Enzystream safety | Severity and incidence of adverse events | Up to 88 days | Yes |
| Primary | To demonstrate Dermastream-Enzystream safety | No deterioration in clinical laboratory parameters | 5 days | Yes |
| Secondary | •Assessment of changes in wound debridement status during treatment period | Change in non viable tissue area | Days 1-5 | No |
| Secondary | Assessment of wound closure | Reduction of nonviable tissue area | Up to 88 days | No |
| Secondary | Assessment of wound closure | Increase of granulation tissue area | Up to 88 days | No |
| Secondary | Assessment of wound closure | Time (in days) for wound closure | Up to 88 days | No |