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Background:
Systematic Review

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

by
George Theodorakopoulos
1,* and
David G. Armstrong
2
1
Private Practice, 19200 Elefsina, Greece
2
USC Limb Preservation Program, Southwestern Academic Limb Salvage Alliance (SALSA), Center to Stream Healthcare in Place (C2SHiP), Department of Surgery and Neurological Surgery, Keck School of Medicine of the University of Southern California, Los Angeles, CA 90033, USA
*
Author to whom correspondence should be addressed.
Diabetology 2026, 7(3), 61; https://doi.org/10.3390/diabetology7030061 (registering DOI)
Submission received: 15 January 2026 / Revised: 17 February 2026 / Accepted: 12 March 2026 / Published: 17 March 2026

Abstract

Background: Preventing diabetic foot ulcer (DFU) recurrence after healing is a major challenge in the remission phase. In this context, remission is not synonymous with healed; it refers to a confirmed post-healing state in which the ulcer is closed, but the individual remains at high risk of recurrence and requires ongoing preventive care. Armstrong, Boulton, and Bus suggested that DFU recurrence is about 40% at 1 year, 60% at 3 years, and 65% at 5 years and argued that limb preservation should follow a long-term “survivorship” model similar to cancer care. However, these estimates combine heterogeneous follow-up intervals and definitions, and there is limited work focusing specifically on the first 12 months after confirmed remission. Methods: This systematic review was conducted in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) 2020 statement. Searches of PubMed/MEDLINE, Scopus, ScienceDirect, and the Cochrane Library were performed on 16 December 2025. Eligible studies enrolled adults with diabetes in confirmed remission after a healed DFU and reported an exact 12-month recurrence outcome (n/N or Kaplan–Meier estimate). Risk of bias was assessed using the Critical Appraisal Skills Program and Joanna Briggs Institute tools, and certainty of evidence was evaluated using the Grading of Recommendations, Assessment, Development and Evaluations (GRADE) approach. Twelve-month recurrence proportions were pooled using a random-effects model on the logit scale, and results were interpreted cautiously due to the limited number of eligible cohorts. Results: Across three cohorts with confirmed remission at baseline (total n = 469) and an exact 12-month outcome, the pooled 12-month recurrence proportion was 29.3% (random-effects; 95% CI 24.9–34.1), i.e., about one in three. Although this estimate is lower than the widely cited ~40% 1-year recurrence benchmark, it reflects a strictly defined remission population and a fixed 12-month timepoint, rather than mixed follow-up intervals or less precise definitions. Conclusions: Approximately one in three adults in remission after a healed DFU develop a recurrent ulcer within 12 months. Because this estimate is based on a small number of cohorts and on strictly confirmed remission, it should be interpreted cautiously and should not be generalized to all individuals with a healed DFU. These findings support prevention-focused surveillance and ongoing risk management during remission. Larger, preregistered multicenter cohorts with standardized remission and recurrence definitions are needed to refine short-term recurrence estimates and inform survivorship-style models of care.

1. Introduction

Diabetic foot ulceration (DFU) is a major complication of diabetes and a growing problem for health systems worldwide [1]. It is more than “just a wound”: DFU reduces quality of life and long-term function [2], and approximately one in four people with diabetes will develop a foot ulcer during their lifetime [3]. DFU is also a leading cause of non-traumatic lower-extremity amputation. Mortality after a healed DFU is high and can be similar to, or worse than, several common cancers [4,5,6]. In a recent international analysis, three-year DFU recurrence was approximately 58% and three-year reintervention for chronic limb-threatening ischemia (CLTI) was about 50%, comparable to outcomes seen in advanced breast, colorectal, prostate, and lung cancers [7]. By contrast, similar recurrence rates in diabetic foot disease are often normalized, despite comparable impacts on morbidity, mortality, and healthcare utilization. This parallel supports the concept that DFU remission care should be planned and delivered with a long-term focus similar to cancer survivorship care. Even after ulcer closure, around one in three individuals develop a recurrent DFU within one year [5]. This contributes to continued use of acute care, hospital admissions, and follow-up resources [3]. Early multicenter studies identified the highest-risk group—people with peripheral neuropathy and a prior ulcer—providing the foundation for systematic screening and prevention strategies [8]. International guidance, including recommendations from the International Working Group on the Diabetic Foot (IWGDF), supports an integrated approach to recurrence prevention. This includes therapeutic footwear to reduce plantar pressure, structured education, regular professional foot care, and, in selected high-risk patients, remote temperature monitoring [9].
Healing marks a transition from treating an active ulcer to the longer-term task of preventing recurrence [10]. However, healing is frequently misinterpreted by patients and primary care providers as a “cure.” In reality, remission reflects closure of the skin rather than restoration of normal tissue integrity or resilience. Even when the skin appears intact, the previously ulcerated site often remains molecularly vulnerable tissue, characterized by persistent alterations in collagen structure, impaired microcirculation, inflammatory priming, and reduced tolerance to mechanical stress. Building on the remission concept introduced by Armstrong, Boulton, and Bus [11], re-ulceration after remission is common and is driven by tissue vulnerability, abnormal biomechanics, and behavioral factors [5,12]. Classic biomechanical studies have linked recurrence risk to abnormal plantar loading, with particularly high peak plantar pressures observed in Charcot arthropathy, underscoring the central role of off-loading in prevention [13]. However, even when off-loading is prescribed, non-adherence and everyday activity patterns can limit its effectiveness in real-world settings [14]. As a result, recurrence is often the rule rather than the exception, with high rates reported even within 12 months after healing [6]. Recurrent events increase cumulative costs and are associated with hospital readmissions for diabetes-related foot disease [3]. These observations highlight the need for clinical pathways that prioritize proactive post-remission prevention rather than reactive care after new ulcers appear [15].
Important questions remain regarding the optimal frequency of professional foot care and monitoring during remission [11], the level of adherence required for off-loading and self-care to be effective in daily life [16], and how best to use early, objective risk markers rather than relying solely on visual inspection [17,18]. Technology-based approaches, such as temperature- or pressure-guided feedback and remote monitoring, aim to support adherence and enable earlier detection of risk [4,17]. Observational cohorts describe baseline recurrence risk and its variation between health systems [5], while subgroup analyses—such as studies of patients with Charcot midfoot deformity—clarify how footwear use and plantar pressures interact with recurrence risk [12]. Population-level data provide information on disease burden and risk profiles that can inform service planning [1]. In addition, randomized strategy trials have shown that at-home temperature monitoring can support self-surveillance and reduce recurrence in high-risk populations [19]. We focus on 12 months because it is a clinically actionable timepoint for planning surveillance intensity and prevention resources and avoids mixing outcomes across variable follow-up durations. Taken together, these studies define key drivers of DFU recurrence and highlight the importance of mechanical load, adherence, patient engagement, and targeted adjunctive therapies in narrowing the prevention gap [8,10,14,15,19]. We build directly on the 2017 New England Journal of Medicine review by Armstrong, Boulton, and Bus [11], which reframed post-closure care as remission and reported recurrence of approximately 40% at 1 year, 60% at 3 years, and 65% at 5 years. More recent work extending the survivorship analogy [7] reinforces the view that remission care for diabetic foot disease should resemble survivorship care in oncology—organized, measurable, and multidisciplinary.

2. Research Gap and Aim

Despite the extensive literature on DFU prevention, there is no recent, harmonized estimate of 12-month DFU recurrence after remission based on strictly comparable single-arm data. Existing figures often combine different study designs, endpoints, and follow-up periods, limiting their usefulness for planning and decision-making. A remission-focused synthesis that reports uncertainty measures and explicitly addresses multi-cohort publications and sensitivity analyses is needed to support clinical and service-level decisions. Target parameter: the 12-month DFU recurrence proportion (cumulative incidence) among adults with diabetes in confirmed remission at baseline. We focus on single-arm data because the objective is a baseline risk estimate at a fixed timepoint, rather than comparative effectiveness across heterogeneous interventions and care settings. The aim of this review is to provide a decision-ready estimate of 12-month DFU recurrence after remission. We do this by pooling strict 12-month, single-arm recurrence data using a random-effects meta-analysis on the logit scale, reporting confidence intervals and heterogeneity statistics, and testing robustness through cohort-only and per-publication versus per-cohort analytic strategies, as detailed in the Supplementary Materials.

3. Materials and Methods

3.1. Study Design

We conducted a focused systematic review and single-arm meta-analysis to estimate the proportion of adults with diabetes who experience recurrence of a diabetic foot ulcer (DFU) within 12 months after documented healing (remission). This review was reported in accordance with PRISMA 2020 [20], and the PRISMA checklist is provided in the Supplementary Materials. The review was designed to address a narrow, clinically practical question: how often does DFU recurrence occur in the first year after remission, when follow-up planning decisions are typically made? Because the aim was descriptive and decision-supportive rather than comparative, we restricted the quantitative synthesis to single-arm recurrence data at a fixed timepoint. Target parameter: the 12-month DFU recurrence proportion (cumulative incidence) among adults with diabetes in confirmed remission at baseline, based on an exact 12-month recurrence outcome (n/N or Kaplan–Meier estimate).

3.2. Eligibility Criteria

Eligibility criteria were structured using a Population, Intervention/Exposure, Comparator, Outcome (and Study design) [PICO(S)] framework. Population: adults (≥18 years) with diabetes and a healed DFU at baseline (defined as remission). Outcome: DFU recurrence after healing. Study design: randomized trials or prospective or retrospective cohort studies. Intervention/Comparison: not specified for the quantitative objective because the primary aim was a baseline risk estimate at a fixed timepoint rather than a comparative effectiveness analysis.
Eligibility for systematic review inclusion (qualitative synthesis): We included clinical studies that:
Enrolled adults (≥18 years) with diabetes and a healed DFU at baseline (defined as remission);
Were randomized trials or prospective or retrospective cohort studies with a remission sample size of at least 10 participants.
We excluded studies that:
Enrolled only patients with active ulcers;
Did not clearly distinguish recurrent from incident ulceration;
Were case reports, reviews, protocols, editorials, or conference abstracts without full data;
Were preclinical or non-human studies.
Eligibility for quantitative pooling (meta-analysis): For the quantitative synthesis, we additionally required cohorts to have confirmed remission at baseline and to report DFU recurrence at exactly 12 months as a proportion (n/N) or Kaplan–Meier estimate. Studies meeting the review inclusion criteria but not these additional pooling criteria were retained for qualitative synthesis only. Accordingly, we categorized included studies as primary (eligible for pooling) versus contextual (qualitative only), and present them separately. Contextual studies were included when they were relevant to remission-care pathways (e.g., recurrence prevention strategies or risk characterization), even if cohorts were not restricted to confirmed remission at baseline; these studies were not eligible for quantitative pooling.

3.3. Information Sources and Search Strategy

On 16 December 2025, we searched PubMed/MEDLINE, Scopus, ScienceDirect, and the Cochrane Library using the same predefined keyword set across all databases: (“diabetic foot” OR DFU) AND (recurrence OR remission) AND “healed ulcer” AND (randomised OR randomized). Search limits were applied for publication year (2015–2026, depending on database), English language, and human studies where available. Database-specific filters (year, language, human studies) were applied before export; the 1505 records represent filtered exports, not raw database yields. The review protocol was developed prospectively but was not registered in the International Prospective Register of Systematic Reviews (PROSPERO). This review was conceived as a focused synthesis of a narrowly defined outcome (single-arm 12-month recurrence after confirmed remission), with no planned comparisons between interventions. No deviations from the a priori eligibility criteria or analytic plan occurred. To mitigate the risk of selective outcome reporting despite non-registration, we prespecified the fixed 12-month pooling endpoint and report all prespecified sensitivity analyses.

3.4. Study Selection

Titles and abstracts were screened independently by two reviewers (G.T and D.G.A). Full texts were retrieved for records considered potentially eligible. Disagreements at any stage were resolved by consensus. Duplicate records were identified and removed manually before full-text assessment by comparing title, authors, year, journal, and DOI/registry identifiers where available. The study selection process is summarized in the PRISMA flow diagram. A third reviewer was not used to adjudicate disagreements; this is acknowledged as a limitation.

3.5. Data Extraction

Two reviewers (G.T and D.G.A) independently extracted data on study design, setting, population characteristics, definition of remission and recurrence, follow-up duration, remission cohort size, and recurrence counts or estimates. Data were recorded in a prespecified extraction table created by the authors and populated manually (no dedicated extraction software was used). Extracted data were cross-checked for accuracy and reconciled by consensus. For randomized trials providing data for multiple intervention arms, results were collapsed into a single cohort to avoid unit-of-analysis errors and provide a conservative overall estimate of 12-month recurrence. Study-level recurrence counts used in the meta-analysis are provided in the Supplementary Materials to support reproducibility.

3.6. Risk of Bias and Certainty Assessment

Randomized controlled trials were appraised using the Critical Appraisal Skills Programme (CASP) checklist [21]. Observational studies were assessed using the Joanna Briggs Institute (JBI) cohort or prevalence checklists, as appropriate [22]. The overall certainty of evidence for the pooled 12-month recurrence estimate was assessed using the Grading of Recommendations, Assessment, Development and Evaluations (GRADE) framework [23], with particular attention to risk of bias, indirectness, and imprecision given the small number of eligible cohorts.

3.7. Outcome Measure

The primary outcome was DFU recurrence within 12 months after documented healing. Recurrence was defined as the development of a new DFU at any site following complete epithelialization of the index ulcer. Outcomes reported at other timepoints were described qualitatively. Only outcomes reported at exactly 12 months were eligible for pooling.

3.8. Statistical Analysis

We pooled single-arm 12-month recurrence proportions using a random-effects meta-analysis on the logit scale to account for expected clinical and methodological variability between cohorts. Pooled estimates were back-transformed to proportions for interpretation. Statistical heterogeneity was assessed using Cochran’s Q test (chi-squared test for heterogeneity), the I2 statistic (the proportion of total variability attributable to between-study heterogeneity rather than sampling error), and τ2 (tau-squared) (the estimated between-study variance in a random-effects model), recognizing that heterogeneity estimates can be imprecise when few cohorts are available.
Sensitivity analyses were conducted by excluding randomized data and by comparing per-cohort versus per-publication aggregation strategies. All analyses were performed using MetaAnalysisOnline.com (A5 Genetics Ltd., Budapest, Hungary) [24]. Results are interpreted cautiously and are intended to support clinical planning rather than precise epidemiologic inference.

4. Results

4.1. Study Selection

After de-duplication and screening of titles/abstracts and full texts, 10 studies were included in the review (qualitative synthesis) [1,3,4,5,10,12,15,16,17,18]. Of these, three remission cohorts (k = 3) from two publications reported confirmed remission at baseline and an exact 12-month recurrence outcome and were included in the main quantitative synthesis [5,10]. The remaining included studies did not meet these additional criteria for quantitative pooling and were retained for qualitative synthesis only. The study selection process and reasons for exclusion are shown in the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) 2020 flow diagram (Figure 1) [20].

4.2. Study Characteristics

Key characteristics of the included studies are summarized in Table 1. Most studies enrolled adults at high risk of recurrence (e.g., prior ulcer, peripheral neuropathy, or Charcot foot deformity) and evaluated prevention strategies including visit frequency, temperature monitoring, therapeutic footwear, and adjunctive monitoring technologies [1,3,4,5,10,12,15,16,17,18]. Only three cohorts—the overall DIATIME trial arm reported by López-Moral et al. and the German and Czech remission cohorts reported by Ogurtsova et al. reported 12-month recurrence data suitable for quantitative pooling (Table 2) [5,10]. The remaining studies informed background recurrence risk, adherence, mechanisms, or prevention strategies but did not meet criteria for inclusion in the 12-month meta-analysis and were therefore included in the qualitative synthesis only [1,3,4,13,17,18,19,20,21]. Detailed risk-of-bias assessments and certainty-of-evidence judgments are provided in the Supplementary Materials. Baseline remission/healing definitions for pooled cohorts are summarized in Table 3.

4.3. Pooled 12-Month Recurrence Estimate

Across the three remission cohorts (k = 3), crude 12-month diabetic foot ulcer recurrence ranged from approximately 25% to 34% [5,10]. Using a random-effects model on the logit scale, the pooled 12-month recurrence proportion was 29.3% (95% CI 24.9–34.1%), with low statistical heterogeneity (I2 ≈ 17%), as shown in Figure 2. This estimate is lower than the approximately 40% 1-year recurrence reported in the 2017 New England Journal of Medicine review by Armstrong, Boulton, and Bus [11], likely reflecting the stricter requirement for documented remission at baseline and an exact 12-month outcome in the present analysis. Study-level recurrence counts used in the meta-analysis are provided in the Supplementary Materials to support reproducibility. Given the small number of eligible cohorts, pooled estimates and heterogeneity measures should be interpreted cautiously.

5. Discussion

In this review, approximately one in three adults in remission after a healed diabetic foot ulcer developed a new ulcer within 12 months. Across three remission cohorts, 12-month recurrence ranged from roughly 25% to 34%, with a pooled estimate of about 29–30%. This is lower than the approximately 40% 1-year recurrence reported by Armstrong, Boulton, and Bus [11], likely reflecting our focus on cohorts with documented remission at baseline and an exact 12-month follow-up rather than mixed timepoints. However, post-healing recurrence rates in broader diabetic foot ulcer (DFU) populations vary widely depending on the types of patients included and how follow-up is done. For example, a prospective clinic cohort reported a 31% recurrence within 12 months among participants whose ulcers healed [25], while a Japanese wound-care center cohort reported 40.3% recurrence at 1 year after healing [26]. In a tertiary interdisciplinary clinic population, recurrence was higher—54.4% at 12 months after first healing [27]. Given differences in services, visit schedules, and patient risk profiles, this ~30% figure should be viewed as a decision-support estimate rather than a fixed rate, but it remains high enough to justify structured follow-up and sustained prevention efforts after healing. Moreover, disparities in outcomes among patients admitted with diabetic foot infections—including higher amputation rates and inequitable access to revascularization across racial and ethnic groups—underscore the importance of ensuring that remission-care pathways are not only structured but also equitable [28]. In addition, reported rates depend on what each study means by “recurrence” (for example, an ulcer returning at the same site versus a new ulcer elsewhere, including the other foot), which can meaningfully change the reported rate.
Biomechanical and behavioral factors help explain why recurrence remains common despite contemporary care. Some patients have such high mechanical risk that ulcers recur even with good adherence to prescribed footwear; for example, individuals with Charcot midfoot deformity demonstrate high levels of custom-footwear use yet still experience recurrence rates exceeding 40% [12]. In these cases, additional mechanical, orthotic, or surgical strategies may be required. At the same time, patient engagement and daily behavior represent important leverage points for prevention. For example, providing custom-made footwear designed specifically for indoor use has been shown to significantly increase objectively measured indoor footwear adherence at both 1 month and 12 months, addressing a common gap in prevention behavior after healing [29]. Technology-assisted strategies may also support prevention during remission. In the multicenter DIATEMP randomized trial, at-home plantar skin temperature monitoring added to usual care did not significantly reduce ulcer recurrence at or near the measured sites over 18 months. However, it did reduce recurrence at any foot site, with the benefit most evident among participants who reduced walking activity when a hotspot was detected [30]. Other technology-enabled approaches focus on pressure. In an 18-month randomized trial, an intelligent insole system providing personalized audio-visual-vibrational feedback reduced the number of high-pressure bouts during daily life compared with a control condition, with group differences emerging after approximately 16 weeks—suggesting that people learned to avoid activities that triggered alerts and adjusted their offloading accordingly [31]. Together, these findings support a remission-care approach that combines mechanical off-loading, education and support, and—where feasible—technology-assisted monitoring. In addition to mechanical strategies, emerging person-centered behavioral interventions—including remotely delivered cognitive-behavioral approaches with digital maintenance support—aim to improve foot-care behavior and psychological well-being after healing, reflecting the need to address behavioral and emotional barriers during remission (Figure 3) [32].
The finding that approximately one in three patients in remission will re-ulcerate within a year has direct implications for how we structure post-healing follow-up. The DIATIME trial demonstrated that 4-week screening intervals were superior to 8- and 12-week intervals (López-Moral et al.), and Ogurtsova et al. showed that patients with a first-ever ulcer had longer time to recurrence than those with prior episodes, suggesting that intensity of surveillance should be calibrated to individual risk history. This work has several limitations. Although the protocol was written in advance, it was not registered. The pooled estimate is based on a small number of remission cohorts with a modest total sample size, and definitions of recurrence, follow-up intensity, and confirmation methods varied between studies. We used a DerSimonian–Laird random-effects model on the logit scale; with few cohorts, estimates of heterogeneity and prediction intervals should be interpreted cautiously. In addition, disagreements during study selection and data extraction were resolved by consensus between two reviewers (G.T and D.G.A) without adjudication by a third reviewer, which may increase the risk of unresolved bias. These limitations underscore the need for larger, preregistered remission cohorts with standardized outcome definitions. Pooling DIATIME’s three screening arms provides a pragmatic overall estimate, but it may not reflect untreated baseline risk because the screening interval likely influences recurrence [10].

6. Conclusions

Based on a small number of cohorts with confirmed remission after a healed diabetic foot ulcer, approximately 30% of adults developed a recurrent ulcer within 12 months. This represents a clinically important risk and is similar in scale to outcomes observed in several common cancers [7]. These findings support the view that DFU remission should be managed as a chronic, relapsing state rather than as the end of treatment. They also highlight the first year after ulcer closure—and particularly the first 90–180 days—as a potentially volatile phase of remission during which early relapse may be common, supporting a care model with structured surveillance, appropriate off-loading and footwear, behavioral support, and, where feasible, simple monitoring tools. At the same time, the evidence base remains limited. Although multiple major databases were searched, only a small number of cohorts met strict remission confirmation and exact 12-month outcome criteria, and definitions and confirmation methods varied between studies. Accordingly, the ~30% estimate should be interpreted as a practical, decision-support guide for high-risk remission populations, and should not be generalized to all individuals with a healed DFU. Larger, preregistered, multicenter remission cohorts with standardized remission and recurrence definitions are needed to refine short-term recurrence risk and inform the development of clear, survivorship-style care pathways for diabetic foot disease.

Supplementary Materials

The following supporting information can be downloaded at: https://www.mdpi.com/article/10.3390/diabetology7030061/s1. S1: Information Sources and Search Date; S2: Search Strategy (Database-Specific); S3: Study Selection and Record Management; S4: Data Extraction; S5: Risk of Bias and Certainty of Evidence; S6: Statistical Synthesis and Software; S7: PRISMA 2020 Checklist; Table S1: 12-month diabetic foot ulcer recurrence counts (single-arm).

Author Contributions

Conceptualization, G.T. and D.G.A.; methodology, G.T. and D.G.A.; literature search and screening, G.T.; data extraction, G.T.; risk of bias assessment, G.T. and D.G.A.; GRADE appraisal, G.T. and D.G.A.; formal analysis and meta-analysis, D.G.A. and G.T.; visualization, G.T.; resources, D.G.A.; supervision, D.G.A.; writing—original draft preparation, G.T.; writing—review and editing, D.G.A. and G.T. All authors have read and agreed to the published version of the manuscript.

Funding

This research received no external funding.

Institutional Review Board Statement

Not applicable.

Informed Consent Statement

Not applicable.

Data Availability Statement

All data used in this systematic review and meta-analysis were derived from published studies. Extracted datasets and analytic inputs supporting the findings of this study are available from the corresponding author upon reasonable request.

Acknowledgments

G.T. gratefully acknowledges David G. Armstrong for his collaboration on this work and for his mentorship, scholarly guidance, and constructive feedback during the development of the manuscript.

Conflicts of Interest

The authors declare no conflicts of interest.

Abbreviations

CASPCritical Appraisal Skills Program (RCT checklist)
CIConfidence Interval
CPTSCumulative Plantar Tissue Stress
CLTIChronic Limb-Threatening Ischemia
DFDDiabetes-Related Foot Disease
DFUDiabetic Foot Ulcer
GRADEGrading of Recommendations Assessment, Development and Evaluation
IWGDFInternational Working Group on the Diabetic Foot
I2Inconsistency Statistic (percentage of variability due to heterogeneity)
JBIJoanna Briggs Institute (cohort appraisal tool)
kNumber of Included Studies/Cohorts in a Meta-Analysis
KMKaplan–Meier (12-month estimate)
LOPSLoss of Protective Sensation
MEDLINEMedical Literature Analysis and Retrieval System Online (via PubMed)
NSample Size
ORCOxidized Regenerated Cellulose (in collagen–ORC dressings)
PADPeripheral Arterial Disease
PIPrediction Interval
PRISMAPreferred Reporting Items for Systematic Reviews and Meta-Analyses
QCochran’s Q (heterogeneity statistic)
RCTRandomized Controlled Trial
RRRisk Ratio
τ2Between-Study variance (random-effects)

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Figure 1. PRISMA 2020 flow diagram of study selection.
Figure 1. PRISMA 2020 flow diagram of study selection.
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Figure 2. Twelve-month diabetic foot ulcer recurrence after remission: random-effects meta-analysis. Study-level 12-month diabetic foot ulcer (DFU) recurrence proportions (events/total) and pooled estimate from a DerSimonian–Laird random-effects model on the logit scale. Included cohorts are López-Moral 2025 (overall DIATIME arm) [10] and the German and Czech remission cohorts from Ogurtsova 2021 [5]. Results should be interpreted cautiously given the small number of cohorts.
Figure 2. Twelve-month diabetic foot ulcer recurrence after remission: random-effects meta-analysis. Study-level 12-month diabetic foot ulcer (DFU) recurrence proportions (events/total) and pooled estimate from a DerSimonian–Laird random-effects model on the logit scale. Included cohorts are López-Moral 2025 (overall DIATIME arm) [10] and the German and Czech remission cohorts from Ogurtsova 2021 [5]. Results should be interpreted cautiously given the small number of cohorts.
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Figure 3. Survivorship-style model for diabetic foot ulcer remission (conceptual). Conceptual survivorship model for diabetic foot ulcer remission. Key prevention domains during remission include surveillance, offloading optimization, monitoring technologies, and behavioral reinforcement, progressing to long-term survivorship care. The range reflects pooled 12-month recurrence estimates (≈29–30%) and variability across high-risk remission cohorts (≈25–40%). Remission is not equivalent to healing, and not all healed ulcers meet confirmed remission criteria.
Figure 3. Survivorship-style model for diabetic foot ulcer remission (conceptual). Conceptual survivorship model for diabetic foot ulcer remission. Key prevention domains during remission include surveillance, offloading optimization, monitoring technologies, and behavioral reinforcement, progressing to long-term survivorship care. The range reflects pooled 12-month recurrence estimates (≈29–30%) and variability across high-risk remission cohorts (≈25–40%). Remission is not equivalent to healing, and not all healed ulcers meet confirmed remission criteria.
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Table 1. Contextual/background studies included in the qualitative synthesis and used to frame care pathways/risk.
Table 1. Contextual/background studies included in the qualitative synthesis and used to frame care pathways/risk.
Author, YearPopulationMethods12-Month Recurrence Rate (or Follow-up Data)Key Findings (Recurrence/Prevention)
Hajizadeh, M., et al., 2025 [17]43 high-risk patients with peripheral neuropathy and a history of a previous plantar foot ulcer.90-day observational, prospective cohort study using continuous plantar temperature monitoring insoles.N/A (90-day study).This study critiques how recurrence is prevented. It found that 82% of intraday temperature asymmetry signals were nonstationary and 44% of these fluctuated above and below the 2.2 °C hotspot threshold, suggesting that once-daily measurements are unreliable and risk false-positives/negatives.
Rovers, F.J., et al., 2025 [16]151 high-risk participants in the enhanced therapy arm of the DIATEMP trial.18-month cohort analysis assessing adherence to at-home daily foot temperature monitoring.Of 83 patients with a hotspot, 29.1% (44 participants) developed an ulcer during the 18-month follow-upA total of 94 patients (62.3%) adherent to measuring foot temperatures at 1–3 months vs. 4–18: 118 (78.1%) versus 78 (57.4%; p < 0.001).
Kilic, M., et al., 2025 [1]357 adult individuals with diabetes.Multi-centered descriptive cross-sectional study.This is a prevalence study, not a post-remission recurrence study.DFU prevalence was 17.1% (95% CI 13.2–21.5). In regression analysis, peripheral arterial disease, history of ulcer, edema, and interdigital fungus were all linked to higher DFU risk (ORs ≈ 3.78, 26.1, 9.78, and 5.28), with especially strong effects for edema and prior ulcer.
Shih, C.D., et al., 2024 [4]115 high-risk patients; 52.2% had a history of ulcers.Retrospective, multi-center, before-and-after registry study of a continuous remote temperature monitoring (smart sock).Data is reported as a rate per patient-year, not a 12-month cohort percentage.The continuous remote monitoring program resulted in a 68% relative risk reduction in the foot ulceration rate. It also reduced the amputation rate by 83% and the hospitalization rate by 63%.
Hulshof, C.M., et al., 2024 [18]52 high-risk patients with diabetes.Cross-sectional study to develop and compare biomechanical models for cumulative plantar tissue stress (CPTS).N/A (biomechanical modeling study).This study identifies a key mechanism for recurrence. It found that standing (both barefoot and shod) is a major contributor to CPTS and must be included in risk models, not just walking strides. Barefoot walking (39%) and barefoot standing (31%) were the largest contributors.
Alahakoon, C., et al., 2023 [3]190 patients admitted to hospital for DFD (diabetes-related foot disease).Prospective cohort study with 12-month follow-up after hospital admission.52.6% (100 participants) were re-admitted to the hospital for DFD within 12 months.The 1-year DFD-related hospital re-admission rate after a DFD-related admission is extremely high (52.6%). Absent pedal pulses and Loss of Protective Sensation (LOPS) were the only independent risk factors, each doubling the risk of re-admission.
Keukenkamp, R., et al., 2021 [12]20 patients with Charcot midfoot deformity (and ulcer history) vs. 118 non-Charcot high-risk patients.18-month cohort analysis (from DIAFOS trial) comparing plantar pressure and footwear adherence.40% (Charcot) and 47% (non-Charcot) ulcerated over 18 months.Patients with Charcot had exceptionally high adherence to their custom footwear (94.4% at-home). Despite this, their 18-month recurrence rate remained high (40%) and was not statistically different from the non-Charcot group (47%).
Abbott, C.A., et al., 2019 [15]58 high-risk patients with peripheral neuropathy and a recent history of plantar foot ulceration.18-month prospective RCT of an intelligent insole (providing real-time pressure alerts) vs. a control (non-alerting) insole.Not reported as a 12-month rate (18-month follow-up).Real-time pressure alerts reduced DFU site incidence (ulcers per person-day) by 71% over 18 months. For patients with good adherence (n = 40), the reduction was 86%.
DFU, diabetic foot ulcer; DFD, diabetes-related foot disease; CPTS, cumulative plantar tissue stress; and LOPS, loss of protective sensation; N/A is for Non Applicable.
Table 2. Primary studies eligible for quantitative pooling (meta-analysis).
Table 2. Primary studies eligible for quantitative pooling (meta-analysis).
Author, YearPopulationMethods12-Month Recurrence Rate (or Follow-up Data)Key Findings (Recurrence/Prevention)
López-Moral, M., et al., 2025 [10]148 high-risk patients in remission with a healed plantar foot ulcer.Randomized controlled trial (RCT) comparing 4, 8, and 12-week screening for prevention of plantar DFUs and remission.33.8% overall 1-year recurrence
18 (18.4%) (4-week group)
14 (28.6%) (8-week group)
27 (46%) (12-week group)
More frequent (4-week) screening and podiatric care intervals significantly reduced 1-year DFU recurrence rates compared to 8 or 12-week intervals.
Ogurtsova, K., et al., 2021 [5]321 patients (222 German, 99 Czech) with an active DFU who entered remission.Prospective long-term follow-up of two distinct cohorts.28% (German cohort)
25% (Czech cohort).
1-year crude cumulative recurrence was 25–28%. The risk was significantly higher for patients having a consecutive ulcer compared to those healing their first-ever ulcer.
Table 3. Remission (baseline) definition in pooled cohorts (12-month estimate).
Table 3. Remission (baseline) definition in pooled cohorts (12-month estimate).
Study/CohortHow Remission/Healing Was DefinedHow Baseline (Time Zero) Was Set
López-Moral, M., et al., 2025 [10]International Working Group on the Diabetic Foot risk 3; in remission with a healed plantar DFUBaseline at trial entry; healed at exam (active ulcer excluded)
Ogurtsova, K., et al., 2021 GER [5]Full epithelialization, closed ≥4 weeksBaseline at documented healing date (or unilateral major amputation as endpoint)
Ogurtsova, K., et al., 2021 CZ [5]Full epithelialization, closed ≥6 weeksBaseline at documented healing date; if not seen, first patient-reported ulcer-free date used (10–15%)
GER is for GERMANY cohort and CZ for Czech cohort.
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Theodorakopoulos, G.; Armstrong, D.G. The First Year of Remission: A Systematic Review and Meta-Analysis of 12-Month Diabetic Foot Ulcer Recurrence. Diabetology 2026, 7, 61. https://doi.org/10.3390/diabetology7030061

AMA Style

Theodorakopoulos G, Armstrong DG. The First Year of Remission: A Systematic Review and Meta-Analysis of 12-Month Diabetic Foot Ulcer Recurrence. Diabetology. 2026; 7(3):61. https://doi.org/10.3390/diabetology7030061

Chicago/Turabian Style

Theodorakopoulos, George, and David G. Armstrong. 2026. "The First Year of Remission: A Systematic Review and Meta-Analysis of 12-Month Diabetic Foot Ulcer Recurrence" Diabetology 7, no. 3: 61. https://doi.org/10.3390/diabetology7030061

APA Style

Theodorakopoulos, G., & Armstrong, D. G. (2026). The First Year of Remission: A Systematic Review and Meta-Analysis of 12-Month Diabetic Foot Ulcer Recurrence. Diabetology, 7(3), 61. https://doi.org/10.3390/diabetology7030061

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