219-OR: Comparison of the Impact of Autologous Cell Therapy and Conservative Treatment on Chronic Limb-Threatening Ischemia in Patients with Diabetic Foot: A Randomized Controlled Trial

MICHAL DUBSKY; ROBERT BEM; ANDREA NEMCOVA; JITKA HUSÁKOVÁ; VLADIMIRA FEJFAROVA; ALEXANDRA JIRKOVSKA; KAROL SUTORIS

doi:10.2337/db20-219-OR

Oral Presentations: Acute and Chronic Complications

219-OR: Comparison of the Impact of Autologous Cell Therapy and Conservative Treatment on Chronic Limb-Threatening Ischemia in Patients with Diabetic Foot: A Randomized Controlled Trial

MICHAL DUBSKY,
ROBERT BEM,
ANDREA NEMCOVA,
JITKA HUSÁKOVÁ,
VLADIMIRA FEJFAROVA,
ALEXANDRA JIRKOVSKA and
KAROL SUTORIS

Prague, Czech Republic

Diabetes 2020 Jun; 69(Supplement 1): -. https://doi.org/10.2337/db20-219-OR

Abstract

Background: Autologous cell-therapy (ACT) is a new treatment method for patients with diabetes and no-option chronic limb-threatening ischemia (NO-CLTI). We aimed to assess the impact of ACT on CLTI in comparison with standard treatment (ST) in a randomized controlled trial.

Methods: Forty diabetic patients with NO-CLTI were randomized to receive either cell therapy (n=20) or standard conservative therapy (n=16); 4 patients dropped out of the study. After 3 months, those in the ST group were switched to ACT (cell therapy crossover). The effect on ischemia and diabetic foot was assessed by changes in transcutaneous oxygen pressure (TcPO₂) and the number of healed patients at 3 months. Amputation rates and amputation-free survival (AFS) were assessed at 3 months and then during 12-month follow-up.

Results: TcPO₂ increased significantly in the ACT group after 1 and 3 months (both p<0.001) whereas TcPO₂ in the control group remained unchanged (NS). After the crossover to cell therapy in patients of the ST group, we observed a significant increase in TcPO₂ at 1 and 3 months after the injection of ACT (p=0.036 and p<0.001, respectively). We also observed significantly more healed patients at 3 months in the ACT group compared to the ST group (p=0.01). The rates of major amputation and AFS at 3 months were not significantly different between the ACT and ST groups (both NS). In Kaplan-Meier estimate, patients treated initially by ACT showed a trend towards higher AFS rates compared to those treated initially by ST who received ACT after the 3-month delay, but without a significant difference (65 vs. 43.8%).

Conclusions: Our study showed that ACT in patients with no-option CLTI and diabetic foot significantly improved limb ischemia and wound healing when compared to standard conservative therapy, without influencing amputation rates and with a trend to higher 1-year AFS in comparison with delayed ACT treatment in ST group.

Disclosure M. Dubsky: None. R. Bem: None. A. Nemcova: None. J. Husáková: None. V. Fejfarova: None. A. Jirkovska: None. K. Sutoris: None.

Funding Ministry of Health of the Czech Republic (16-27262A, 00023001)

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