Safety and Efficacy Study of HO/03/03 10-40 Micro Grams to Treat Hard to Heal Wounds (H2H)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|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).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01772303
|Contact: Yair Alegrantiemail@example.com|
|Contact: Kira Olshvangfirstname.lastname@example.org|
|Maccabi Health Services, Wound Clinic||Recruiting|
|Contact: Michal Raba +972-50-2400362 email@example.com|
|Contact: Hanna Kaufman, MD +972-50-9063142 firstname.lastname@example.org|
|Principal Investigator: Hanna Kaufman, MD|