Back to resultsSafety and Efficacy Study of HO/03/03 10-40 Micro Grams to Treat Hard to Heal Wounds (H2H)
Primary Purpose
Hard to Heal Wounds
Status
Unknown status
Phase
Early Phase 1
Locations
Israel
Study Type
Interventional
Intervention
HO/03/03 10-40 µg
Sponsored by
About this trial
This is an interventional treatment trial for Hard to Heal Wounds focused on measuring Pressure Ulcers, diabetic Ulcers, post operational wounds
Eligibility Criteria
Inclusion Criteria:
- Age 18 years old and above.
- Chronic wounds that have < 30% change in area from Screening
- Have single / multiple wounds;
- Have a Hard-to-Heal wound(s) of various etiologies
Exclusion Criteria:
- Have a documented medical history of a significant cardiac, pulmonary, gastrointestinal, endocrine (other than Diabetes Mellitus type 1 or 2), hepatic or per the physician's discretion.
Sites / Locations
- Maccabi Health Services, Wound ClinicRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
HO/03/03 10-40 micro gram
Arm Description
Topically treatment with HO/03/03 10-40µg once daily for up to 24 weeks. Subjects will receive treatment with HO/03/03 10µg at a dose of 1-4 vials (i.e. 10-40 µg/administration) daily depending on their wound size.
Outcomes
Primary Outcome Measures
Time to Heal
1. 75% wound closure by or on study week 24 (Time to Event Analysis of incidence and time to 75% wound closure).
Secondary Outcome Measures
Wound closure
1. Complete wound closure by or on week 24 (Time to Event Analysis of incidence and time to 100% wound closure).
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01772303
Brief Title
Safety and Efficacy Study of HO/03/03 10-40 Micro Grams to Treat Hard to Heal Wounds
Acronym
H2H
Official Title
An Open-Label, Prospective, Multicenter Study to Assess the Safety and Efficacy of HO/03/03 10-40 Micro Gram (Wound Size Dependence) Applied Topically for up to 24 Weeks in Subjects With Various Etiologies of Hard-to-Heal Wounds
Study Type
Interventional
2. Study Status
Record Verification Date
April 2013
Overall Recruitment Status
Unknown status
Study Start Date
January 2013 (undefined)
Primary Completion Date
August 2013 (Anticipated)
Study Completion Date
December 2013 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
HealOr
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
This multicenter, prospective, open-label, outpatient study will assess the safety and efficacy of HO/03/03 10µg applied topically once daily for up to 24 weeks in up to 100 subjects with Hard to Heal documented chronic wounds of various etiologies (pressure ulcers, diabetic ulcers, post operational wounds surgical incisions ulcers of rheumatoid arthritis and trauma wounds) of at least 4 weeks documentation.
Detailed Description
All subjects with a wound size of up to 56.25 cm2 (inclusive) will be administered 1 vial of 10 ml HO/03/03 10μg per administration. For each increase in wound size of up to 56.25 cm2 an additional vial of HO/03/03 10 μg will be added up to a maximal wound size area of 225 cm2 (will be measured by HealOr central reviewer) utilizing 40µg (4 vials) per administration. 15 min post treatment wounds will be dressed according to standard of care.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hard to Heal Wounds
Keywords
Pressure Ulcers, diabetic Ulcers, post operational wounds
7. Study Design
Primary Purpose
Treatment
Study Phase
Early Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
HO/03/03 10-40 micro gram
Arm Type
Experimental
Arm Description
Topically treatment with HO/03/03 10-40µg once daily for up to 24 weeks. Subjects will receive treatment with HO/03/03 10µg at a dose of 1-4 vials (i.e. 10-40 µg/administration) daily depending on their wound size.
Intervention Type
Drug
Intervention Name(s)
HO/03/03 10-40 µg
Intervention Description
HO/03/03 10-40µg once daily (Topically) for up to 24 weeks.
Primary Outcome Measure Information:
Title
Time to Heal
Description
1. 75% wound closure by or on study week 24 (Time to Event Analysis of incidence and time to 75% wound closure).
Time Frame
up to 24 weeks
Secondary Outcome Measure Information:
Title
Wound closure
Description
1. Complete wound closure by or on week 24 (Time to Event Analysis of incidence and time to 100% wound closure).
Time Frame
up to 24 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Age 18 years old and above.
Chronic wounds that have < 30% change in area from Screening
Have single / multiple wounds;
Have a Hard-to-Heal wound(s) of various etiologies
Exclusion Criteria:
Have a documented medical history of a significant cardiac, pulmonary, gastrointestinal, endocrine (other than Diabetes Mellitus type 1 or 2), hepatic or per the physician's discretion.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yair Alegranti
Phone
+972-54-3161581
Email
yair@healor.com
First Name & Middle Initial & Last Name or Official Title & Degree
Kira Olshvang
Phone
+972-54-3161572
Email
kira@healor.com
Facility Information:
Facility Name
Maccabi Health Services, Wound Clinic
City
Haifa
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Michal Raba
Phone
+972-50-2400362
Email
raba_m@mac.org.il
First Name & Middle Initial & Last Name & Degree
Hanna Kaufman, MD
Phone
+972-50-9063142
Email
dr.kaufmanh1@gmail.com
First Name & Middle Initial & Last Name & Degree
Hanna Kaufman, MD
12. IPD Sharing Statement
Learn more about this trial
Safety and Efficacy Study of HO/03/03 10-40 Micro Grams to Treat Hard to Heal Wounds
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