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
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). A Medline and Embase search were per...
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| creator | Scatena, Alessia Apicella, Matteo Mantuano, Michele Ragghianti, Benedetta Silverii, Antonio Miranda, Cesare Monge, Luca Uccioli, Luigi Scevola, Germano Stabile, Eugenio Gargiulo, Mauro Vermigli, Cristiana Monami, Matteo |
| description | 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).
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).
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 |
| doi_str_mv | 10.1007/s00592-024-02393-z |
| format | Article |
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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).
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 TcPO
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).
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.</description><identifier>ISSN: 1432-5233</identifier><identifier>EISSN: 1432-5233</identifier><identifier>DOI: 10.1007/s00592-024-02393-z</identifier><identifier>PMID: 39545964</identifier><language>eng</language><publisher>Germany</publisher><ispartof>Acta diabetologica, 2024-11</ispartof><rights>2024. Springer-Verlag Italia S.r.l., part of Springer Nature.</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed><cites>FETCH-LOGICAL-c184t-9de13303eb9a8029efefae0060b30fed259be51d227b230a3209a4d3e6b73cdd3</cites><orcidid>0000-0003-3989-6484</orcidid></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><link.rule.ids>314,776,780,27903,27904</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/39545964$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Scatena, Alessia</creatorcontrib><creatorcontrib>Apicella, Matteo</creatorcontrib><creatorcontrib>Mantuano, Michele</creatorcontrib><creatorcontrib>Ragghianti, Benedetta</creatorcontrib><creatorcontrib>Silverii, Antonio</creatorcontrib><creatorcontrib>Miranda, Cesare</creatorcontrib><creatorcontrib>Monge, Luca</creatorcontrib><creatorcontrib>Uccioli, Luigi</creatorcontrib><creatorcontrib>Scevola, Germano</creatorcontrib><creatorcontrib>Stabile, Eugenio</creatorcontrib><creatorcontrib>Gargiulo, Mauro</creatorcontrib><creatorcontrib>Vermigli, Cristiana</creatorcontrib><creatorcontrib>Monami, Matteo</creatorcontrib><creatorcontrib>Panel of the Italian Guidelines for the Treatment of Diabetic Foot Syndrome and on behalf of SID and AMD</creatorcontrib><creatorcontrib>for the Panel of the Italian Guidelines for the Treatment of Diabetic Foot Syndrome and on behalf of SID and AMD</creatorcontrib><title>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</title><title>Acta diabetologica</title><addtitle>Acta Diabetol</addtitle><description>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).
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).
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 TcPO
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).
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.</description><issn>1432-5233</issn><issn>1432-5233</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2024</creationdate><recordtype>article</recordtype><recordid>eNpVUcFO3DAUtCoqoJQf6KHykUuo7ZdsYm4I0RYJqZf2bL3EL-DKiRfbQdr9N_6tXhZKe3h6I2tmnjXD2CcpzqUQ7ZckRKNVJVRdBjRU23fsWNagqkYBHPyDj9iHlH4LIVUL3SE7At3UjV7Vx-zpcsnBh7uwJD6Q9zzfU8T1ho8hcpeGe5rcwK3DnnIBYwj5giOfKGOFM_pNcomHkUecbZjcliwfwpxj8L7AHB369OxVfLmlR_JhPdGcd5rd001G73Dmd4uz5N1Mb-wcCfMr978f8LSZbQwTfWTvx3KATl_2Cfv19frn1ffq9se3m6vL22qQXZ0rbUkCCKBeYyeUppFGJCFWogcxklWN7qmRVqm2VyAQlNBYW6BV38JgLZyws73vOoaHhVI2U8mmxIUzleQMSNXptqt1U6hqTx1iSCnSaNbRTRg3Rgqzq83sazOlNvNcm9kW0ecX_6WfyP6VvPYEfwAWvZj1</recordid><startdate>20241115</startdate><enddate>20241115</enddate><creator>Scatena, Alessia</creator><creator>Apicella, Matteo</creator><creator>Mantuano, Michele</creator><creator>Ragghianti, Benedetta</creator><creator>Silverii, Antonio</creator><creator>Miranda, Cesare</creator><creator>Monge, Luca</creator><creator>Uccioli, Luigi</creator><creator>Scevola, Germano</creator><creator>Stabile, Eugenio</creator><creator>Gargiulo, Mauro</creator><creator>Vermigli, Cristiana</creator><creator>Monami, Matteo</creator><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>7X8</scope><orcidid>https://orcid.org/0000-0003-3989-6484</orcidid></search><sort><creationdate>20241115</creationdate><title>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</title><author>Scatena, Alessia ; Apicella, Matteo ; Mantuano, Michele ; Ragghianti, Benedetta ; Silverii, Antonio ; Miranda, Cesare ; Monge, Luca ; Uccioli, Luigi ; Scevola, Germano ; Stabile, Eugenio ; Gargiulo, Mauro ; Vermigli, Cristiana ; Monami, Matteo</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c184t-9de13303eb9a8029efefae0060b30fed259be51d227b230a3209a4d3e6b73cdd3</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2024</creationdate><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Scatena, Alessia</creatorcontrib><creatorcontrib>Apicella, Matteo</creatorcontrib><creatorcontrib>Mantuano, Michele</creatorcontrib><creatorcontrib>Ragghianti, Benedetta</creatorcontrib><creatorcontrib>Silverii, Antonio</creatorcontrib><creatorcontrib>Miranda, Cesare</creatorcontrib><creatorcontrib>Monge, Luca</creatorcontrib><creatorcontrib>Uccioli, Luigi</creatorcontrib><creatorcontrib>Scevola, Germano</creatorcontrib><creatorcontrib>Stabile, Eugenio</creatorcontrib><creatorcontrib>Gargiulo, Mauro</creatorcontrib><creatorcontrib>Vermigli, Cristiana</creatorcontrib><creatorcontrib>Monami, Matteo</creatorcontrib><creatorcontrib>Panel of the Italian Guidelines for the Treatment of Diabetic Foot Syndrome and on behalf of SID and AMD</creatorcontrib><creatorcontrib>for the Panel of the Italian Guidelines for the Treatment of Diabetic Foot Syndrome and on behalf of SID and AMD</creatorcontrib><collection>PubMed</collection><collection>CrossRef</collection><collection>MEDLINE - Academic</collection><jtitle>Acta diabetologica</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Scatena, Alessia</au><au>Apicella, Matteo</au><au>Mantuano, Michele</au><au>Ragghianti, Benedetta</au><au>Silverii, Antonio</au><au>Miranda, Cesare</au><au>Monge, Luca</au><au>Uccioli, Luigi</au><au>Scevola, Germano</au><au>Stabile, Eugenio</au><au>Gargiulo, Mauro</au><au>Vermigli, Cristiana</au><au>Monami, Matteo</au><aucorp>Panel of the Italian Guidelines for the Treatment of Diabetic Foot Syndrome and on behalf of SID and AMD</aucorp><aucorp>for the Panel of the Italian Guidelines for the Treatment of Diabetic Foot Syndrome and on behalf of SID and AMD</aucorp><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>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</atitle><jtitle>Acta diabetologica</jtitle><addtitle>Acta Diabetol</addtitle><date>2024-11-15</date><risdate>2024</risdate><issn>1432-5233</issn><eissn>1432-5233</eissn><abstract>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).
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).
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 TcPO
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).
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.</abstract><cop>Germany</cop><pmid>39545964</pmid><doi>10.1007/s00592-024-02393-z</doi><orcidid>https://orcid.org/0000-0003-3989-6484</orcidid></addata></record> |
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| title | 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 |
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