Status:
TERMINATED
Effects of Pulsatile Intravenous (IV) Insulin on Wound Healing in Diabetics
Lead Sponsor:
Florida Atlantic University
Collaborating Sponsors:
Advanced Diabetes Treatment Centers
Conditions:
Wound Healing
Diabetes
Eligibility:
All Genders
18+ years
Phase:
PHASE2
PHASE3
Brief Summary
One of the significant complications associated with some patients with diabetes is the inability for wounds to heal regardless of enrolling and participating in a traditional wound healing program. T...
Detailed Description
Diabetes can produce complications including the inability for wounds to heal despite participating in a traditional wound care therapy program. At times of reduced tissue oxygen, such as when circul...
Eligibility Criteria
Inclusion
- diagnosed with type 1 or type 2 diabetes
- taking oral and/or insulin for diabetes control
- endocrinologist must assess and approve pt for participation in study
- ability to swallow without difficulty
- ability to meet weekly time and testing requirements for this study
Exclusion
- inability to do testing required for study including regular scheduled visits for independent review of non healing wound including assessment, pictures and measurements
- lack of intravenous access
- alcohol abuse, drug addiction or the use of illegal drugs
- positive HIV
- active liver disease
- in active treatment for cancer including radiation or chemotherapy
- inability to breathe into machine for respiratory quotients to monitor progress
Key Trial Info
Start Date :
January 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2012
Estimated Enrollment :
152 Patients enrolled
Trial Details
Trial ID
NCT00967837
Start Date
January 1 2006
End Date
September 1 2012
Last Update
August 10 2016
Active Locations (1)
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1
Florida Atlantic University
Boca Raton, Florida, United States, 33487