Evidence map›Paper›PMID 39545964›Full record

SynthesisActa diabetologica2025

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.

Alessia Scatena, Matteo Apicella, Michele Mantuano, Benedetta Ragghianti, Antonio Silverii, Cesare Miranda, Luca Monge, Luigi Uccioli, Germano Scevola, Eugenio Stabile and 4 more

Erratum issuedAbstract readMeta-Analysis
PubMed Publisher
In one paragraph

Synthesis in Acta diabetologica, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. Cited by 4 papers.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

4 citing papers in PubMed.

  1. Observational
  2. Article
  3. Article
  4. Review
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

14 authors.

Alessia ScatenaDiabetology Unit, Health Authorities South East Tuscany, San Donato Hospital, Via Pietro Nenni 20, 52100, Arezzo, Italy. alessia.scatena@uslsudest.toscana.it.ORCID http://orcid.org/0000-0003-3989-6484
Matteo ApicellaDiabetology Unit, Health Authorities South East Tuscany, San Donato Hospital, Via Pietro Nenni 20, 52100, Arezzo, Italy.
Michele MantuanoDiabetology Unit, Health Authorities South East Tuscany, San Donato Hospital, Via Pietro Nenni 20, 52100, Arezzo, Italy.
Benedetta RagghiantiAzienda Ospedaliero Universitaria Careggi and University of Florence, Florence, Italy.
Antonio SilveriiAzienda Ospedaliero Universitaria Careggi and University of Florence, Florence, Italy.
Cesare MirandaPordenone Hospital, Pordenone, Italy.
Luca MongeAMD - Italian Association of Clinical Diabetologists, Rome, Italy.
Luigi UccioliDiabetes Section CTO Hospital and dept of Biomedicine and prevention Tor Vergata University of Rome, Rome, Italy.
Germano ScevolaOspedale Sandro Pertini, Roma, Italy.
Eugenio StabileAzienda Ospedaliera Regionale "San Carlo", Potenza, Italy.
Mauro GargiuloVascular Surgery, University of Bologna- DIMEC, Bologna, Italy.
Cristiana VermigliUniversity Hospital Perugia, Perugia, Italy.
Matteo MonamiAzienda Ospedaliero Universitaria Careggi and University of Florence, Florence, Italy.
Panel of the Italian Guidelines for the Treatment of Diabetic Foot Syndrome and on behalf of SID and AMD

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

aimTo 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).

methodsA 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).

resultsSeven 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 TcPO

conclusionsACT 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.

Indexed as

Cell- and Tissue-Based TherapyDiabetic FootIschemiaAmputation, SurgicalHumansItalyPractice Guidelines as TopicRandomized Controlled Trials as TopicTransplantation, AutologousWound Healing

Identifiers

What Socratic holds

Textmetadata
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the Socratic graph.