Accelerated Wound Healing in Diabetic Ulcers by Sitagliptin (SitaDFU)

Wolfgang-Michael Franz

Status and phase: Withdrawn; Phase 3

Conditions: Diabetic Foot

Treatments: Drug: Placebo; Drug: Sitagliptin

Study type: Interventional

Funder types: Other

Identifiers

NCT02675335

MISP 52815 (Other Identifier)

2015-005226-19 (EudraCT Number)

SitaDFU_v1.0

Details and patient eligibility

About

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.

Sex: All

Ages: 18 to 100 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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0 participants in 2 patient groups, including a placebo group

Sitagliptin

Active Comparator group

Description:

Sitagliptin tablets, 100mg per day, 12 weeks treatment

Treatment:

Drug: Sitagliptin

Placebo

Placebo Comparator group

Description:

Placebo tablets, 1 tablet per day, 12 weeks treatment

Treatment:

Drug: Placebo