Accelerated Wound Healing in Diabetic Ulcers by Sitagliptin

Status

Withdrawn

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02675335

Acronym

SitaDFU

Enrollment

Registered

2016-02-05

Start date

2016-03-31

Completion date

2018-03-31

Last updated

2016-09-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetic Foot

Keywords

Diabetic foot ulcer, Sitagliptin

Brief summary

The purpose of the study is to test the effect of Sitagliptin on the healing of stable, nonhealing diabetic foot ulcers. This is a randomized placebo-controlled Trial.

Interventions

DRUGSitagliptin

DRUGPlacebo

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 100 Years

Healthy volunteers

Inclusion criteria

* type 2 diabetes mellitus * at least 1 diabetic foot ulcer with a size between 1 and 20 sqcm * stable size of the foot ulcer for at least 2 weeks * HbA1c \<= 8% under Treatment with Insulin, metformin, sulfonylureas, SGLT2 Inhibitors, glinides or glitazones

Exclusion criteria

* local purulent signs of Inflammation at ulcer site * planned interventional or surgical therapy of a macro vessel disease of the lower limb * glomerular filtration rate \<30ml/min * liver cirrhosis CHILD B or C * pregnancy, lactation * allergy against Sitagliptin * ongoing treatment with dipeptidyl peptidase 4 (DPP4) Inhibitors

Design outcomes

Primary

Measure	Time frame
mean ulcer size after a treatment period of 12 weeks	12 weeks

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026