Januvia (Sitagliptin) in Healing Chronic Diabetic Foot Ulcers
The primary objective of this study is to compare the rate of healing as well as percent of wounds healed in Type II diabetic patients with chronic foot ulcerations receiving sitagliptin versus placebo.
The hypothesis for this study is that subjects receiving daily doses of sitagliptin in combination with their regular antihyperglycemic medications will result in increased healing rates as well as a greater number of healed wounds as compared to subjects receiving placebo and their regular antihyperglycemic medications.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Efficacy of Januvia (Sitagliptin) in Healing Chronic Diabetic Foot Ulcers|
- Percent Wounds Healed [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]Compare the rate of healing as well as percent of wounds healed in Type II diabetic patients with chronic foot ulcerations receiving sitagliptin versus placebo.
|Study Start Date:||January 2014|
|Estimated Study Completion Date:||March 2017|
|Estimated Primary Completion Date:||January 2017 (Final data collection date for primary outcome measure)|
Experimental: Januvia (Sitagliptin)
Sitagliptin 100 mg a day for 12 weeks
Comparison of Sitagliptin a dipeptidyl-peptidase four (DPP-4) inhibitor 100mg pill with placebo comparator
Other Name: Januvia
Placebo Comparator: Placebo
Sugar pill manufactured to mimick Sitagliptin 100mg pill.
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Please refer to this study by its ClinicalTrials.gov identifier: NCT02015910
|Contact: Paul J Kim, DPM||202-444-3059|
|United States, District of Columbia|
|Medstar Georgetown University Hospital||Recruiting|
|Washington, District of Columbia, United States, 20007|
|Contact: Paul Kim, DPM 202-444-3059|
|Principal Investigator: Paul Kim, DPM|
|Principal Investigator:||Paul J Kim, DPM||Georgetown University|