Status:
UNKNOWN
Evaluation of Carbothera in the Treatment of Foot Ulcers
Lead Sponsor:
University of Manitoba
Collaborating Sponsors:
Mitsubishi-Rayon-Cleansui
Conditions:
Critical Lower Limb Ischemia
Critical Limb Ischemia
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Foot ulceration usually precedes more serious foot complications such as infection, gangrene or amputation. The risk of developing foot ulcers has been estimated to be higher in individuals with kidne...
Detailed Description
This is a multi-centered, placebo controlled and randomized clinical study designed to evaluate the therapeutic potential of CO2 enriched water on the treatment of distal extremity (foot) ulcers in pa...
Eligibility Criteria
Inclusion
- Male and female participants ≥ 18 years of age with at least one distal extremity ulcer (arterial ischemic ulcer).
- No acute medical illness and on conventional medical management prior to Carbothera.
- Willingness and ability to provide written informed consent
Exclusion
- DVT or PE within 12 months.
- Subjects with known active cancer, HIV, hepatitis B virus, hepatitis C virus, human transmissible spongiform encephalopathy, Treponema pallidum.
- Subjects who are deemed to have an infection of the distal extremity ulcer.
- Women who are pregnant
- Unstable angina.
- Acute MI within 1 month.
- Stroke within 1 month.
- Patient scheduled for revascularization during the 4-month intervention period.
Key Trial Info
Start Date :
September 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2016
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT02239419
Start Date
September 1 2014
End Date
December 1 2016
Last Update
October 30 2015
Active Locations (2)
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1
St. Boniface General Hospital
Winnipeg, Manitoba, Canada, R2H 2A6
2
Health Sciences Centre- Rehabilitation Hospital
Winnipeg, Manitoba, Canada, R3A 1A4