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

Phases

Early Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01772303

Acronym

H2H

Enrollment

100

Registered

2013-01-21

Start date

2013-01-31

Completion date

2013-12-31

Last updated

2013-04-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hard to Heal Wounds

Keywords

Pressure Ulcers, diabetic Ulcers, post operational wounds

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.

Interventions

DRUGHO/03/03 10-40 µg

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

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 90 Years

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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).

Countries

Israel

Contacts

Primary ContactYair Alegranti

yair@healor.com+972-54-3161581

Backup ContactKira Olshvang

kira@healor.com+972-54-3161572

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026