Safety and Efficacy Study of HO/03/03 10-40 Micro Grams to Treat Hard to Heal Wounds (H2H)

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2013 by HealOr
Sponsor:
Information provided by (Responsible Party):
HealOr
ClinicalTrials.gov Identifier:
NCT01772303
First received: January 17, 2013
Last updated: April 3, 2013
Last verified: April 2013
  Purpose

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.


Condition Intervention Phase
Hard to Heal Wounds
Drug: HO/03/03 10-40 µg
Phase 0

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by HealOr:

Primary Outcome Measures:
  • Time to Heal [ Time Frame: up to 24 weeks ] [ Designated as safety issue: No ]
    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:
  • Wound closure [ Time Frame: up to 24 weeks ] [ Designated as safety issue: No ]
    1. Complete wound closure by or on week 24 (Time to Event Analysis of incidence and time to 100% wound closure).


Estimated Enrollment: 100
Study Start Date: January 2013
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: August 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: HO/03/03 10-40 micro gram
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
HO/03/03 10-40µg once daily (Topically) for up to 24 weeks.

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.

  Eligibility

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01772303

Contacts
Contact: Yair Alegranti +972-54-3161581 yair@healor.com
Contact: Kira Olshvang +972-54-3161572 kira@healor.com

Locations
Israel
Maccabi Health Services, Wound Clinic Recruiting
Haifa, Israel
Contact: Michal Raba    +972-50-2400362    raba_m@mac.org.il   
Contact: Hanna Kaufman, MD    +972-50-9063142    dr.kaufmanh1@gmail.com   
Principal Investigator: Hanna Kaufman, MD         
Sponsors and Collaborators
HealOr
  More Information

No publications provided

Responsible Party: HealOr
ClinicalTrials.gov Identifier: NCT01772303     History of Changes
Other Study ID Numbers: HO-H2H-01-2011
Study First Received: January 17, 2013
Last Updated: April 3, 2013
Health Authority: "Institutional Review Board:Israel"

Keywords provided by HealOr:
Pressure Ulcers, diabetic Ulcers, post operational wounds

ClinicalTrials.gov processed this record on July 24, 2014