Safety and Efficacy Study of HO/03/03 10-40 Micro Grams to Treat Hard to Heal Wounds (H2H)
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.
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|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|
- Time to Heal [ Time Frame: up to 24 weeks ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]1. Complete wound closure by or on week 24 (Time to Event Analysis of incidence and time to 100% wound closure).
|Study Start Date:||January 2013|
|Estimated Study Completion Date:||December 2013|
|Estimated Primary Completion Date:||August 2013 (Final data collection date for primary outcome measure)|
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.
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.
|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|