Januvia (Sitagliptin) in Healing Chronic Diabetic Foot Ulcers
|ClinicalTrials.gov Identifier: NCT02015910|
Recruitment Status : Terminated (Terminated by the sponsor due to slow enrollment)
First Posted : December 19, 2013
Results First Posted : January 6, 2017
Last Update Posted : January 6, 2017
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.
|Condition or disease||Intervention/treatment||Phase|
|Type II Diabetes||Drug: Sitagliptin Drug: Placebo||Phase 4|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||1 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Efficacy of Januvia (Sitagliptin) in Healing Chronic Diabetic Foot Ulcers|
|Study Start Date :||January 2014|
|Actual Primary Completion Date :||January 2015|
|Actual Study Completion Date :||January 2015|
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.
- Percent Wounds Healed [ Time Frame: 12 weeks ]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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02015910
|United States, District of Columbia|
|Medstar Georgetown University Hospital|
|Washington, District of Columbia, United States, 20007|
|Principal Investigator:||Paul J Kim, DPM||Georgetown University|