Offloading systems for the treatment of neuropathic foot ulcers in patients with diabetes mellitus: a meta-analysis of randomized controlled trials for the development of the Italian guidelines for the treatment of diabetic foot syndrome

Carlotta Gauna; Francesco Romeo; Alessia Scatena; Cesare Miranda; Luigi Uccioli; Cristiana Vermigli; Antonio Volpe; Corrado Bordieri; Rodolfo Tramonta; Benedetta Ragghianti; Giulia Bandini; Matteo Monami; Luca Monge; Panel of the Italian Guidelines for the Treatment of Diabetic Foot Syndrome* and on behalf of SID and AMD

doi:10.1007/s00592-024-02262-9

Offloading systems for the treatment of neuropathic foot ulcers in patients with diabetes mellitus: a meta-analysis of randomized controlled trials for the development of the Italian guidelines for the treatment of diabetic foot syndrome

Acta Diabetol. 2024 Mar 15. doi: 10.1007/s00592-024-02262-9. Online ahead of print.

Authors

Affiliations

¹ Endocrinology and Metabolism, Azienda Sanitaria Locale Città di Torino, Turin, Italy. carlotta.gauna@aslcittaditorino.it.
² SC Territorial Diabetology, Azienda Sanitaria Locale Torino 5, Turin, Italy.
³ Ospedale San Donato, Arezzo, Italy.
⁴ Pordenone Hospital, Pordenone, Italy.
⁵ University of Rome Tor Vergata, Rome, Italy.
⁶ Azienda Ospedaliera Santa Maria della Misericordia, Ospedale di Perugia, Perugia, Italy.
⁷ Policlinico Abano Terme, Padua, Italy.
⁸ Università Cattolica del Sacro Cuore di Roma, Rome, Italy.
⁹ Asl Roma 4, Civitavecchia, Italy.
¹⁰ Azienda Ospedaliero Universitaria Careggi and University of Florence, Florence, Italy.
¹¹ AMD-Italian Association of Clinical Diabetologists, Rome, Italy.

PMID: 38489054
DOI: 10.1007/s00592-024-02262-9

Abstract

Aim: To compare the effectiveness of commonly used offloading devices for the treatment of neuropathic foot ulcers in patients with diabetes mellitus. This meta-analysis (MA) has been performed for giving an answer to clinical questions on this topic of the Italian guideline on diabetic foot syndrome.

Methods: The present MA includes randomized controlled studies (duration > 12 weeks) comparing, in patients with diabetes mellitus and non-infected neuropathic foot ulcer: any offloading device vs either no offloading device or conventional footwear; removable versus non-removable offloading devices; surgical procedure vs other offloading approaches. The primary endpoint was ulcer healing.

Results: A total of 184 studies were identified, and 18 were considered eligible for the analysis. We found that: any plantar off-loading, when compared to the absence of plantar offloading device, is associated with a higher ulcer healing (MH-OR: 3.13 [1.08, 9.11], p = 0.04, I² = 0%); total contact cast or nonremovable knee-high walker, compared to other offloading devices, had a higher ulcer healing rate (MH-OR: 2.64 [1.43, 4.89], p = 0.002, I² = 51%); surgical offloading for active ulcers in combination with post-surgery offloading achieves higher ulcer healing rate when compared to offloading devices alone (MH-OR: 6.77 [1.64, 27.93], p = 0.008, I² = 0%).

Conclusions: Any plantar offloading, compared to the absence of plantar offloading device, is associated with a higher ulcer healing rate. Total contact cast or nonremovable knee-high walker, compared to other offloading devices, is preferable. Surgical offloading for active ulcers, in combination with post-surgery offloading devices, achieves a higher ulcer healing rate when compared to other offloading devices alone. Further studies with a larger cohort of patients with diabetic neuropathic foot ulcers and extended follow-up periods are necessary.

Keywords: Diabetes mellitus; Neuropathic foot ulcer; Offloading.

Publication types

Review