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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Hard to Heal Wounds

Intervention / Treatment
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* Drug: HO/03/03 10-40 µg


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: HO/03/03 10-40 micro gram<br>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<br>* HO/03/03 10-40µg once daily (Topically) for up to 24 weeks.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pressure Ulcers, diabetic Ulcers, post operational wounds