Safety and Efficacy Study of HO/03/03 10-40 Micro Grams to Treat Hard to Heal Wounds

Hard to Heal Wounds Clinical Trial

— 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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01772303
• Other study ID #: HO-H2H-01-2011
• Status: Recruiting
• Phase: Phase 0
• First received: January 17, 2013
• Last updated: April 3, 2013
• Start date: January 2013
• Est. completion date: December 2013

Study information

• Verified date: April 2013
• Source: HealOr
• Contact: Yair Alegranti
• Phone: +972-54-3161581
• Email: yair[@]healor.com
• Is FDA regulated: No
• Health authority: "Institutional Review Board:Israel"
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 2013
• Est. primary completion date: August 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 90 Years

Eligibility

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.

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hard to Heal Wounds

Intervention

Drug:
• HO/03/03 10-40 µg
HO/03/03 10-40µg once daily (Topically) for up to 24 weeks.

Locations

Country	Name	City	State
Israel	Maccabi Health Services, Wound Clinic	Haifa

Sponsors (1)

Lead Sponsor	Collaborator
HealOr

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).	up to 24 weeks	No
Secondary	Wound closure	1. Complete wound closure by or on week 24 (Time to Event Analysis of incidence and time to 100% wound closure).	up to 24 weeks	No