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

Early Phase 1

• Conditions: Hard to Heal Wounds
• Interventions: Drug: HO/03/03 10-40 µg

• Registration Number: NCT01772303
• Lead Sponsor: HealOr

Brief 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.

Study Timeline

• Study Start: 2013-01
• Study First Submitted: 2013-01-17
• Study First Submitted QC: 2013-01-18
• Study First Posted: 2013-01-21
• Status Verified: 2013-04
• Last Update Submitted: 2013-04-03
• Last Update Posted: 2013-04-04
• Primary Completion: 2013-08
• Study Completion: 2013-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
HO/03/03 10-40 micro gram	HO/03/03 10-40 µg	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.

Primary Outcome Measures

Name	Time	Method
Time to Heal	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).

Secondary Outcome Measures

Name	Time	Method
Wound closure	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).

Trial Locations

Locations (1)

Maccabi Health Services, Wound Clinic; 🇮🇱 Haifa, Israel