Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HO/03/03 10-40 micro gram | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HO/03/03 10-40 µg | Drug | HO/03/03 10-40µg once daily (Topically) for up to 24 weeks. |
|
| 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 |
| 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 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yair Alegranti | Contact | +972-54-3161581 | yair@healor.com | |
| Kira Olshvang | Contact | +972-54-3161572 | kira@healor.com |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Maccabi Health Services, Wound Clinic | Recruiting | Haifa | Israel |
Not provided
| ID | Term |
|---|---|
| D003668 | Pressure Ulcer |
| ID | Term |
|---|---|
| D012883 | Skin Ulcer |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided