Effects of Pulsatile Intravenous (IV) Insulin on Wound Healing in Diabetics
Stopped early · Phase 2/Phase 3
Conditions studied: Wound Healing, Diabetes
In brief
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. There have been a number of anecdotal evidence presented by patients receiving pulsatile intravenous insulin therapy for other complications with non healing wounds lasting from several months to several years whose wounds healed while receiving therapy. This study was designed to specifically monitor the progress of diabetic patients who have failed traditional wound care therapy and monitor the progress of their wounds while receiving pulsatile intravenous insulin therapy.
Key facts
- Study ID
- NCT00967837
- Run by
- Florida Atlantic University
- People needed
- 152
- Starts
- 2006-01-01
- Expected to finish
- 2012-09-01
- Last updated by the study team
- 2016-08-10
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Florida Atlantic University — Boca Raton, Florida, United States
Full record on ClinicalTrials.gov
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