Efficacy of autologous cell therapy in the treatment of chronic limb-threatening ischaemia in people with diabetes: a randomised controlled trial

Kód výsledku v IS VaVaI

<a href="https://www.isvavai.cz/riv?ss=detail&h=RIV%2F00023001%3A_____%2F23%3A00084673" target="_blank" >RIV/00023001:_____/23:00084673 - isvavai.cz</a>

Výsledek na webu

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DOI - Digital Object Identifier

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Jazyk výsledku

angličtina

Název v původním jazyce

Efficacy of autologous cell therapy in the treatment of chronic limb-threatening ischaemia in people with diabetes: a randomised controlled trial

Popis výsledku v původním jazyce

Background and aims: There are still many patients with the most severe stages of chronic limb threatening ischemia (CLTI) who are not suitable for any kind of standard revascularization, Autologous cell therapy (ACT) is a novel treatment approach for patients With diabetes and no-option CLTI (NOCLTI). The aim of our study was to analyze the impact of ACT on NO-CLTI in comparison with standard conservative treatment (ST) in a randomized controlled trial,Materials and methods: Diabetic patients with NO-CLTI treated in our centre over 6 years were randomized to receive either ACT (n=28) or ST (n=27). After 12 weeks, those in the ST group, who did not improve were treated with ACT. The effect of ACT on ischemia and wound healing was assessed by changes in transcutaneous oxygen pressure (TcP02) and the number of healed patients at 12 weeks. Pain was evaluated by Visual Analogue Scale (VAS). Amputation rates and amputation-free survival (AFS) were assessed in both groups.Results: During the first 12 weeks, TcP02 increased in the ACT group from 19.6±9.1 to 40.2±17.6 mm Hg (p=O.004) whereas there was no change in the ST group (from 20.4±10.9 to 23.1±13.7 mm Hg).Difference in TcP02 in the ACT group compared to ST group was 17.9 mm Hg (p=0.038) after 12 weeks. In the period from week 12 to week 24, when patients from ST group received ACT, the TcP02 in this group increased from 20.4±10.9 to 39.7±13.6 (p=O.006) while it did not change significantly in the ACT in this period. At 24 weeks, there was no significant difference in mean TcP02 between the two groups. Wound healing was greater at 12 weeks in the ACT group in non-amputated patients compared to the ST group (8/23 vs, 1/19, pain measured using VAS was significantly reduced in the ACT group after 12 weeks compared to ST group (p&lt;0.001). There was no difference in rates of major amputation and AFS between both groups at 12 weeks.Conclusion: This study showed that ACT in patients with no-option CLTI and diabetic foot significantly improved limb ischemia and wound healing after 12 weeks compared to conservative standard therapy. Larger randomized controlled trials are needed to confirm the benefits of ACT in patients with NO-CLTI and diabetic foot disease.

Název v anglickém jazyce

Efficacy of autologous cell therapy in the treatment of chronic limb-threatening ischaemia in people with diabetes: a randomised controlled trial

Popis výsledku anglicky

Background and aims: There are still many patients with the most severe stages of chronic limb threatening ischemia (CLTI) who are not suitable for any kind of standard revascularization, Autologous cell therapy (ACT) is a novel treatment approach for patients With diabetes and no-option CLTI (NOCLTI). The aim of our study was to analyze the impact of ACT on NO-CLTI in comparison with standard conservative treatment (ST) in a randomized controlled trial,Materials and methods: Diabetic patients with NO-CLTI treated in our centre over 6 years were randomized to receive either ACT (n=28) or ST (n=27). After 12 weeks, those in the ST group, who did not improve were treated with ACT. The effect of ACT on ischemia and wound healing was assessed by changes in transcutaneous oxygen pressure (TcP02) and the number of healed patients at 12 weeks. Pain was evaluated by Visual Analogue Scale (VAS). Amputation rates and amputation-free survival (AFS) were assessed in both groups.Results: During the first 12 weeks, TcP02 increased in the ACT group from 19.6±9.1 to 40.2±17.6 mm Hg (p=O.004) whereas there was no change in the ST group (from 20.4±10.9 to 23.1±13.7 mm Hg).Difference in TcP02 in the ACT group compared to ST group was 17.9 mm Hg (p=0.038) after 12 weeks. In the period from week 12 to week 24, when patients from ST group received ACT, the TcP02 in this group increased from 20.4±10.9 to 39.7±13.6 (p=O.006) while it did not change significantly in the ACT in this period. At 24 weeks, there was no significant difference in mean TcP02 between the two groups. Wound healing was greater at 12 weeks in the ACT group in non-amputated patients compared to the ST group (8/23 vs, 1/19, pain measured using VAS was significantly reduced in the ACT group after 12 weeks compared to ST group (p&lt;0.001). There was no difference in rates of major amputation and AFS between both groups at 12 weeks.Conclusion: This study showed that ACT in patients with no-option CLTI and diabetic foot significantly improved limb ischemia and wound healing after 12 weeks compared to conservative standard therapy. Larger randomized controlled trials are needed to confirm the benefits of ACT in patients with NO-CLTI and diabetic foot disease.

Druh

A - Audiovizuální tvorba

CEP obor

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OECD FORD obor

30202 - Endocrinology and metabolism (including diabetes, hormones)

Projekt

<a href="/cs/project/LX22NPO5104" target="_blank" >LX22NPO5104: Národní institut pro výzkum metabolických a kardiovaskulárních onemocnění</a><br>

Návaznosti

P - Projekt vyzkumu a vyvoje financovany z verejnych zdroju (s odkazem do CEP)

Rok uplatnění

2023

Kód důvěrnosti údajů

S - Úplné a pravdivé údaje o projektu nepodléhají ochraně podle zvláštních právních předpisů

ISBN

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Místo vydání

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Název nakladatele resp. objednatele

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Verze

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Identifikační číslo nosiče

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