Wound Healing Effects of HO/03/03 In Patients With Diabetic Neuropathic Plantar and Venous Ulcers, Pilot Study.
NCT00338923 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 22
Last updated 2007-08-17
Summary
This is a multicenter pilot study to assess the healing effects of HO/03/03 on diabetic neuropathic plantar and venous ulcers.
HO/03/03 action mechanism involves the manipulation of keratinocyte and fibroblast migration and differentiation at the wound area.
* The primary end point of this study is assessment of safety in treating with HO/03/03 and the efficacy of the drug to promote wound closure of chronic wounds.
* The secondary end points are assessment time to closure and healing rate for the measurement of wound healing progression.
Conditions
- Diabetic Foot Ulcer
- Venous Ulcer
Interventions
- DRUG
-
HO/03/03
Sponsors & Collaborators
-
HealOr
lead INDUSTRY
Principal Investigators
-
Micha Rapoport, Dr. · Assaf Harofe Medical Center
-
Leon Gilead, Dr. · Hadassah Ein Kerem Medical Center
-
Zvi Landau, Dr. · Kaplan Medical Center
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2006-06-30
- Completion
- 2007-05-31
Countries
- Israel
Study Locations
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