Sitagliptin, a DPP-4 Inhibitor, Effectively Promotes the Healing of Diabetic Foot Ulcer: A Randomized Controlled Trial

Background

This randomized controlled trial (RCT) was designed to evaluate the effects of sitagliptin on diabetic foot ulcers (DFUs).

Methods

This was a randomized, open-label clinical trial. The participants were assigned to either the control group, which received standard conventional therapy alone, or the sitagliptin treatment group, which received an oral administration of sitagliptin (100 mg once daily) in conjunction with standard conventional therapy. The primary endpoints were the ulcer healing rate and adverse reactions. The secondary endpoints included the time to ulcer healing, peripheral blood CD34+ endothelial progenitor cells (EPCs) count, serum levels of stromal cell-derived factor-1α (SDF-1α), and glycosylated hemoglobin A1c (HbA1c).

Results

A total of 62 subjects were enrolled in this trial, with 31 individuals assigned to each group. One participant from each group was lost to follow-up. Posttrial analysis revealed that, compared with the control group, the sitagliptin group demonstrated a significantly greater reduction in ulcer area and improved efficacy in terms of ulcer healing (p < 0.05). Although not statistically significant (p = 0.071), the sitagliptin group also tended to have a shorter ulcer healing time. Additionally, the sitagliptin group presented significantly greater numbers of CD34+ EPCs and higher SDF-1α levels compared to the control group (p < 0.05). No statistically significant difference in HbA1c levels was observed between the two groups (p > 0.05). No adverse events associated with sitagliptin treatment were reported.

Conclusions

The DPP-4 inhibitor sitagliptin may facilitate the healing of DFUs independent of its glucose-lowering effects, potentially by enhancing the mobilization of CD34 + EPCs in peripheral blood.

Trial Registration: Registration number: ChiCTR 2000029230, Approval date: 2020/01/19