Accelerated Wound Healing in Diabetic Ulcers by Sitagliptin

• Status: Withdrawn
• Trial end date: 2018-03-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Wolfgang-Michael Franz
• Treatments: Sitagliptin Phosphate

Criteria

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