Autologous cell therapy for ischemic diabetic foot: a meta-analysis of randomized controlled trials for the development of the Italian guidelines for the treatment of diabetic foot syndrome
- 15.11.2024
- Original Article
Erschienen in:
- Verfasst von
- Alessia Scatena
- Matteo Apicella
- Michele Mantuano
- Benedetta Ragghianti
- Antonio Silverii
- Cesare Miranda
- Luca Monge
- Luigi Uccioli
- Germano Scevola
- Eugenio Stabile
- Mauro Gargiulo
- Cristiana Vermigli
- Matteo Monami
- for the Panel of the Italian Guidelines for the Treatment of Diabetic Foot Syndrome and on behalf of SID and AMD
- Erschienen in
- Acta Diabetologica | Ausgabe 5/2025
Abstract
Aim
To assess the efficacy and safety of autologous cell therapy (ACT) in patients with ischemic diabetic foot ulcers (DFU). The present meta-analysis was designed to support the development of the Italian Guidelines for the Treatment of Diabetic Foot Syndrome (DFS).
Methods
A Medline and Embase search were performed up to Feb 1st, 2024 collecting all RCTs including diabetic patients or reporting subgroup analyses on diabetic patients with ischemic foot ulcers comparing ACT with placebo/no therapy/standard of care (SoC), with a duration of at least 26 weeks. Prespecified endpoints were: major amputation (principal) and minor amputation, ulcer healing, time-to-healing, transcutaneous oxygen pressure (TcPO2), ankle-brachial index (ABI), pain, and all-cause mortality (secondary). Any ACT was allowed, irrespective of cell product type and route of administration (intra-arterial and intramuscular).
Results
Seven studies fulfilled all inclusion criteria, all using intramuscular transplantation as route of administration, but only 2 had a follow-up greater than 26 weeks. Participants treated with ACT had a significantly lower risk of major amputations in comparison with SoC/placebo (MH-OR 0.47 [0.24, 0.92], p = 0.03). ACT was also associated with a significantly higher rate of ulcer healing (MH-OR: 10.1 [3.5, 29.6], p < 0.001), greater increase of TcPO2 and ABI values (WMD: 17.57 [13.02, 22.12], p < 0.001), and reduction of pain (WMD: -1.83 [-2.32, -1.34], p = 0.003).
Conclusions
ACT must be considered as a potential therapy for patients with ischemic diabetic foot ulcers. Further studies are needed to better clarify their role in the treatment and management of DFS.
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- Titel
- Autologous cell therapy for ischemic diabetic foot: a meta-analysis of randomized controlled trials for the development of the Italian guidelines for the treatment of diabetic foot syndrome
- Verfasst von
-
Alessia Scatena
Matteo Apicella
Michele Mantuano
Benedetta Ragghianti
Antonio Silverii
Cesare Miranda
Luca Monge
Luigi Uccioli
Germano Scevola
Eugenio Stabile
Mauro Gargiulo
Cristiana Vermigli
Matteo Monami
for the Panel of the Italian Guidelines for the Treatment of Diabetic Foot Syndrome and on behalf of SID and AMD
- Publikationsdatum
- 15.11.2024
- Verlag
- Springer Milan
- Erschienen in
-
Acta Diabetologica / Ausgabe 5/2025
Print ISSN: 0940-5429
Elektronische ISSN: 1432-5233 - DOI
- https://doi.org/10.1007/s00592-024-02393-z
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