Safety and Efficacy Study of HO/03/03 10-40 Micro Grams to Treat Hard to Heal Wounds (H2H)
|ClinicalTrials.gov Identifier: NCT01772303|
Recruitment Status : Unknown
Verified April 2013 by HealOr.
Recruitment status was: Recruiting
First Posted : January 21, 2013
Last Update Posted : April 4, 2013
|Condition or disease||Intervention/treatment||Phase|
|Hard to Heal Wounds||Drug: HO/03/03 10-40 µg||Early Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||100 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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 Start Date :||January 2013|
|Estimated Primary Completion Date :||August 2013|
|Estimated Study Completion Date :||December 2013|
Experimental: HO/03/03 10-40 micro gram
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.
Drug: HO/03/03 10-40 µg
HO/03/03 10-40µg once daily (Topically) for up to 24 weeks.
- Time to Heal [ Time Frame: up to 24 weeks ]1. 75% wound closure by or on study week 24 (Time to Event Analysis of incidence and time to 75% wound closure).
- Wound closure [ Time Frame: up to 24 weeks ]1. Complete wound closure by or on week 24 (Time to Event Analysis of incidence and time to 100% wound closure).
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01772303
|Contact: Yair Alegrantifirstname.lastname@example.org|
|Contact: Kira Olshvangemail@example.com|
|Maccabi Health Services, Wound Clinic||Recruiting|
|Contact: Michal Raba +972-50-2400362 firstname.lastname@example.org|
|Contact: Hanna Kaufman, MD +972-50-9063142 email@example.com|
|Principal Investigator: Hanna Kaufman, MD|