The First Year of Remission: A Systematic Review and Meta-Analysis of 12-Month Diabetic Foot Ulcer Recurrence
Abstract
1. Introduction
2. Research Gap and Aim
3. Materials and Methods
3.1. Study Design
3.2. Eligibility Criteria
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- Enrolled adults (≥18 years) with diabetes and a healed DFU at baseline (defined as remission);
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- Were randomized trials or prospective or retrospective cohort studies with a remission sample size of at least 10 participants.
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- Enrolled only patients with active ulcers;
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- Did not clearly distinguish recurrent from incident ulceration;
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- Were case reports, reviews, protocols, editorials, or conference abstracts without full data;
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- Were preclinical or non-human studies.
3.3. Information Sources and Search Strategy
3.4. Study Selection
3.5. Data Extraction
3.6. Risk of Bias and Certainty Assessment
3.7. Outcome Measure
3.8. Statistical Analysis
4. Results
4.1. Study Selection
4.2. Study Characteristics
4.3. Pooled 12-Month Recurrence Estimate
5. Discussion
6. Conclusions
Supplementary Materials
Author Contributions
Funding
Institutional Review Board Statement
Informed Consent Statement
Data Availability Statement
Acknowledgments
Conflicts of Interest
Abbreviations
| CASP | Critical Appraisal Skills Program (RCT checklist) |
| CI | Confidence Interval |
| CPTS | Cumulative Plantar Tissue Stress |
| CLTI | Chronic Limb-Threatening Ischemia |
| DFD | Diabetes-Related Foot Disease |
| DFU | Diabetic Foot Ulcer |
| GRADE | Grading of Recommendations Assessment, Development and Evaluation |
| IWGDF | International Working Group on the Diabetic Foot |
| I2 | Inconsistency Statistic (percentage of variability due to heterogeneity) |
| JBI | Joanna Briggs Institute (cohort appraisal tool) |
| k | Number of Included Studies/Cohorts in a Meta-Analysis |
| KM | Kaplan–Meier (12-month estimate) |
| LOPS | Loss of Protective Sensation |
| MEDLINE | Medical Literature Analysis and Retrieval System Online (via PubMed) |
| N | Sample Size |
| ORC | Oxidized Regenerated Cellulose (in collagen–ORC dressings) |
| PAD | Peripheral Arterial Disease |
| PI | Prediction Interval |
| PRISMA | Preferred Reporting Items for Systematic Reviews and Meta-Analyses |
| Q | Cochran’s Q (heterogeneity statistic) |
| RCT | Randomized Controlled Trial |
| RR | Risk Ratio |
| τ2 | Between-Study variance (random-effects) |
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| Author, Year | Population | Methods | 12-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-up | A 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%. |
| Author, Year | Population | Methods | 12-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. |
| Study/Cohort | How Remission/Healing Was Defined | How 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 DFU | Baseline at trial entry; healed at exam (active ulcer excluded) |
| Ogurtsova, K., et al., 2021 GER [5] | Full epithelialization, closed ≥4 weeks | Baseline at documented healing date (or unilateral major amputation as endpoint) |
| Ogurtsova, K., et al., 2021 CZ [5] | Full epithelialization, closed ≥6 weeks | Baseline at documented healing date; if not seen, first patient-reported ulcer-free date used (10–15%) |
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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
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 StyleTheodorakopoulos, 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 StyleTheodorakopoulos, 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
