NCT01772303

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

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

• Status: Unknown
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: HealOr · Industry
• Sex: All
• Age: 18 Years – 90 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Hard to Heal Wounds

Interventions

Type	Name	Description
DRUG	HO/03/03 10-40 µg	HO/03/03 10-40µg once daily (Topically) for up to 24 weeks.

Timeline

• Start date: 2013-01-01
• Primary completion: 2013-08-01
• Completion: 2013-12-01
• First posted: 2013-01-21
• Last updated: 2013-04-04

Locations

1 site across 1 country: Israel