Aim: Autologous cell therapy (ACT) using bone marrow-derived mononuclear cells is an alternative treatment approach for patients no-option chronic limb-threatening ischemia (NO-CLTI). Diabetic foot infection (DFI) could negatively influence healing and amputation rates in patients with NO-CLTI. The aim of our study was to analyze the impact of DFI on the clinical outcomes of cell therapy in diabetic patients with NO-CLTI.

Methods: One-hundred-forty-nine ACT applications was performed in 124 patients with NO-CLTI who were treated in our foot clinic over 15 years were included in the study. ACT applications were divided in 2 groups - DFI group with the presence of clinical signs of infection (n=46) and non-DFI group (n=103). Both groups were compared in baseline values and the changes in transcutaneous oxygen pressure (TcPO2) were evaluated after 6 months. Major amputation, amputation-free-survival (AFS) and ulcer healing were assessed during the whole follow-up after ACT (3 months to 14.3 years).

Results: Median AFS in the non-DFI group was 4.6 years CI95=(3.7, 6.3), significantly higher compared to 1.4 years CI95=(0.5, 3.0) in the DFI group. Ulcer healing was significantly better in the non-DFI group with median time to heal 0.9 years CI95=(0.7, 1.1) compared to the DFI group where less than 40% of ulcers healed and lower bound of mean time to heal CI95=6.6 years. TcPO2 in DFI and no-DFI groups was without a significant difference at baseline. At 6 months it increased by 21.7 mmHg CI95=(18.0, 25.3) in the non-DFI group and by 29.8 mmHg CI95=(22.5, 37.2) in the DFI group. The difference between groups was significant (p=0.032).

Conclusions: Our study showed that patients with NO-CLTI and baseline presence of DFI treated by ACT had significantly lower AFS and significantly worse ulcer healing. Therefore, the indication of ACT in patients with clinical signs of infection should be carefully considered.

Disclosure

M.Dubsky: None. J.Husáková: None. V.Fejfarova: None. K.Sutoris: None. D.Sojáková: None. R.Jarošíková: None. M.Kahle: None.

Funding

National Institute for Research of Metabolic and Cardiovascular Diseases (EXCELES LX22NPO5104); European Union; Next Generation EU; MZO (00023001)

© 2023 by the American Diabetes Association
2023
Readers may use this article as long as the work is properly cited, the use is educational and not for profit, and the work is not altered. More information is available at http://www.diabetesjournals.org/content/license.