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

• Status: Unknown status
• Trial end date: 2013-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Early Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: HealOr

Criteria

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.