UnknownEarly Phase 1

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

Israel100 participantsStarted 2013-01

Plain-language 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.

Who can participate

Age range18 Years – 90 Years

SexALL

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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.

What they're measuring

Time to Heal

Timeframe: up to 24 weeks

Trial details

NCT IDNCT01772303

SponsorHealOr

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2013-08

Contact for this trial

Yair Alegranti

+972-54-3161581 yair@healor.com

View on ClinicalTrials.gov More Hard to Heal Wounds trials