A Systematic Review and Meta-Analysis of 12-Month Diabetic Foot Ulcer Recurrence

The First Year of Remission: A Systematic Review and Meta-Analysis of 12-Month Diabetic Foot Ulcer Recurrence

Summary: Published March 17, 2026 in Diabetology (MDPI), this PRISMA 2020-compliant systematic review and random-effects meta-analysis from a Greek private practice clinician (Elefsina) and David G. Armstrong (USC Keck School of Medicine / SALSA) addresses a specific and clinically actionable gap: what is the actual 12-month recurrence rate for diabetic foot ulcers (DFUs) in adults with confirmed remission at baseline? The widely cited benchmark of approximately 40% recurrence at one year — drawn from Armstrong, Boulton, and Bus’s landmark 2017 NEJM review — has been critiqued for combining heterogeneous follow-up intervals and imprecise definitions of remission. This analysis restricted pooling to three cohorts with confirmed remission (defined as fully healed and ulcer-free at baseline) and an exact 12-month outcome: the overall DIATIME trial arm (López-Moral et al., 2025) and two prospective remission cohorts from Germany and the Czech Republic (Ogurtsova et al., 2021), totalling 469 participants. Using a DerSimonian–Laird random-effects model on the logit scale, the pooled 12-month recurrence proportion was 29.3% (95% CI 24.9–34.1%), with low heterogeneity (I² ≈ 17%). Individual cohort rates ranged from approximately 25% (Czech) to 34% (Czech/German overall). This estimate, approximately one in three adults, is lower than the broadly quoted ~40% figure but still clinically high enough to support structured surveillance. The authors frame DFU remission through a cancer-survivorship lens: like cancer remission, healed DFU does not mean restored tissue normalcy — the previously ulcerated site remains molecularly vulnerable, with altered collagen, impaired microcirculation, and reduced mechanical tolerance. They note that the DIATIME trial also demonstrates that 4-week surveillance intervals significantly outperform 8- and 12-week intervals in preventing recurrence. The GRADE certainty of evidence is rated low, and the review was not PROSPERO-registered, though no deviations from the pre-specified analytic plan occurred. Larger, preregistered, multicenter cohorts with standardised definitions are explicitly called for.

Key Highlights:

  • Pooled 12-month DFU recurrence in confirmed-remission populations: 29.3% (95% CI 24.9–34.1%; k=3 cohorts, n=469) — approximately one in three adults; lower than the widely cited ~40% benchmark, reflecting stricter remission definition and fixed 12-month timepoint
  • Individual cohort recurrence range: ~25% (Czech cohort, Ogurtsova 2021) to 33.8% (DIATIME overall arm, López-Moral 2025); DIATIME showed 18.4% recurrence with 4-week screening vs. 46% with 12-week screening — surveillance frequency matters significantly
  • Remission ≠ healed: the authors emphasise that apparent skin closure masks persistent molecular vulnerability — altered collagen structure, impaired microcirculation, inflammatory priming, and reduced mechanical tolerance — consistent with the survivorship model
  • Cancer survivorship parallel: three-year DFU recurrence (~58%) and reintervention rates for CLTI (~50%) are comparable to those of advanced breast, colorectal, prostate, and lung cancers (Armstrong et al., 2025, Int Wound J) — normalisation of these rates in diabetic foot disease is a recognised systemic problem
  • Technology-assisted prevention: DIATEMP RCT found at-home plantar temperature monitoring reduced recurrence at any foot site, especially when patients reduced activity upon hotspot detection; intelligent insole systems with personalised pressure feedback reduced high-pressure events after ~16 weeks of use
  • Limitations: GRADE low-certainty evidence; small k (3 cohorts); review not PROSPERO-registered; disagreements resolved by two-reviewer consensus without third-party adjudication; DIATIME data collapse across arms may underestimate baseline risk

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Keywords: DFU recurrence remissiondiabetic foot ulcer survivorship12-month DFU outcomespost-healing diabetic foot surveillancemeta-analysis diabetic foot ulcerDIATIME trial DFU

George Theodorakopoulos, David G. Armstrong