Trial Outcomes & Findings for Januvia (Sitagliptin) in Healing Chronic Diabetic Foot Ulcers (NCT NCT02015910)

Results Overview

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.

Recruitment status

TERMINATED

Study phase

PHASE4

Target enrollment

1 participants

Primary outcome timeframe

12 weeks

Results posted on

2017-01-06

Participant Flow

Participant milestones

Participant milestones
Measure	Januvia (Sitagliptin) Sitagliptin 100 mg a day for 12 weeks Sitagliptin: Comparison of Sitagliptin a dipeptidyl-peptidase four (DPP-4) inhibitor 100mg pill with placebo comparator	Placebo Placebo Placebo: Sugar pill manufactured to mimick Sitagliptin 100mg pill.
Overall Study STARTED	0	1
Overall Study COMPLETED	0	1
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Januvia (Sitagliptin) in Healing Chronic Diabetic Foot Ulcers

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Januvia (Sitagliptin) Sitagliptin 100 mg a day for 12 weeks Sitagliptin: Comparison of Sitagliptin a dipeptidyl-peptidase four (DPP-4) inhibitor 100mg pill with placebo comparator	Placebo n=1 Participants Placebo Placebo: Sugar pill manufactured to mimick Sitagliptin 100mg pill.	Total n=1 Participants Total of all reporting groups
Age, Categorical <=18 years	—	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	—	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical >=65 years	—	1 Participants n=7 Participants	1 Participants n=5 Participants
Age, Continuous	—	68 years STANDARD_DEVIATION 0 • n=7 Participants	68 years STANDARD_DEVIATION 0 • n=5 Participants
Gender Female	—	0 Participants n=7 Participants	0 Participants n=5 Participants
Gender Male	—	1 Participants n=7 Participants	1 Participants n=5 Participants

PRIMARY outcome

Timeframe: 12 weeks

Population: Data analysis not completed due to insufficient enrollment.

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.

Outcome measures

Outcome data not reported

Adverse Events

Januvia (Sitagliptin)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Paul J. Kim, DPM, Director of Research

Georgetown University Medical Center

Phone: 202-444-3059

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place