NCT01772303

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P75+ for early_phase_1

Timeline
Completed

Started Jan 2013

Shorter than P25 for early_phase_1

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2013

Completed
16 days until next milestone

First Submitted

Initial submission to the registry

January 17, 2013

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 21, 2013

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2013

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2013

Completed
Last Updated

April 4, 2013

Status Verified

April 1, 2013

Enrollment Period

7 months

First QC Date

January 17, 2013

Last Update Submit

April 3, 2013

Conditions

Hard to Heal Wounds

Keywords

Pressure Ulcers, diabetic Ulcers, post operational wounds

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Wound closure

    up to 24 weeks

Study Arms (1)

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.

Drug: HO/03/03 10-40 µg

Interventions

HO/03/03 10-40 µgDRUG

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

HO/03/03 10-40 micro gram

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Maccabi Health Services, Wound Clinic

Haifa, Israel

RECRUITING

MeSH Terms

Conditions

Pressure Ulcer

Condition Hierarchy (Ancestors)

Skin UlcerSkin DiseasesSkin and Connective Tissue Diseases

Central Study Contacts

Yair Alegranti

CONTACT

+972-54-3161581yair@healor.com

Kira Olshvang

CONTACT

+972-54-3161572kira@healor.com

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 17, 2013

First Posted

January 21, 2013

Study Start

January 1, 2013

Primary Completion

August 1, 2013

Study Completion

December 1, 2013

Last Updated

April 4, 2013

Record last verified: 2013-04

Locations

IL(1)