Januvia (Sitagliptin) in Healing Chronic Diabetic Foot Ulcers

• Status: Terminated
• Trial end date: 2015-01-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Georgetown University
• Collaborator: Merck Sharp & Dohme Corp.
• Treatments: Sitagliptin Phosphate

Criteria

Inclusion Criteria:

• Male or female age >18

• Type II Diabetes with glycated hemoglobin (hemoglobin A1C) of < 11

• Currently on an oral hyperglycemic medication other than sitagliptin

• A chronic wound defined as the lack of wound healing progress of <15% per week or 50% over a month period

• Ankle brachial index of > 0.80

• Wound located on the foot or ankle (Wagner Grade 1,2)

• Able to comply with the requirements of the research trial

Exclusion Criteria:

• Current use of dipeptidyl-peptidase four (DPP-4) inhibitor or glucagon like peptide one (GLP-1)agonist

• End stage renal disease

• Currently enrolled in another research trial that involves treatment of the wound

• Active infection of the wound

• Wound that probes to bone with osteomyelitis (Wagner Grade 3)