Diabetic Foot — Prevention & Risk

PER-DFU-COMP-01 · Infection

58% · ≈50–60%

(a) infected at presentation (n=1,229) · (b) of ulcers become infected

(a) Infected at presentation to specialist centres; (b) ulcers becoming infected over their course — two labelled metrics

🟢 Verified · Registry audit 2026-11-06 · Pending triple review

🔄Flip the card — population, dispute & sources

PER-DFU-COMP-02 · Hospitalisation

Up to ~20%

require hospitalisation

DFU patients requiring hospital admission

🟡 Qualified · Registry audit 2026-11-06 · Pending triple review

🔄Flip the card — population, dispute & sources

PER-DFU-CTX-01 · DFU precedes ~80% of diabetes-related amputations; 5-year mortality ~30% (context)

CONTEXT ONLY: DFU precedes ~80% of diabetes-related amputations; 5-yr mortality ~30%

This is the reason prevention matters, quoted once.

🟡 Qualified · Registry audit 2026-11-06 · Pending triple review

🔄Flip the card — population, dispute & sources

PER-DFU-PREV-01 · Lifetime incidence of DFU

19–34%

Proportion of people with diabetes who develop ≥1 foot ulcer during their lifetime

🟢 Verified · Registry audit 2026-11-06 · Pending triple review

🔄Flip the card — population, dispute & sources

PER-DFU-PREV-02 · Annual incidence of DFU

~2% per year (2.2% in the UK community study)

New ulcers per year among people with diabetes

🟢 Verified · Registry audit 2026-11-06 · Pending triple review

🔄Flip the card — population, dispute & sources

PER-DFU-PREV-03 · Point prevalence of active DFU

6.3% (95% CI 5.4–7.3)

higher in men (4.5%) than women (3.5%), and in type 2 (6.4%) than type 1 (5.5%)

Proportion of people with diabetes with an active foot ulcer at a given time

🟢 Verified · Registry audit 2026-11-06 · Pending triple review

🔄Flip the card — population, dispute & sources

PER-DFU-PREV-04 · Diabetic peripheral neuropathy — prevalence

Point prevalence ≈30% · and · ~50% develop DPN over a lifetime

(pooled; 95% CI ~25–34) — up to of diabetes

DPN by clinical/neurophysiological criteria — two different metrics, published split, never blended (Dispute D4)

🔴 Disputed · Registry audit 2026-11-06 · Pending triple review

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PER-DFU-PREV-05 · PAD among people with a DFU

49%

restated as "approximately half" by IWGDF 2023 and JAMA 2023

PAD diagnosed (ABI <0.9 in EURODIALE) in patients presenting with a new DFU

🟢 Verified · Registry audit 2026-11-06 · Pending triple review

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PER-DFU-PREV-06 · Ulcer composition by perfusion status

No PAD: 51% · PAD present: 49% · majority · purely ischaemic ulcers are a small minority

(24% uninfected + 27% infected) · (18% uninfected + 31% infected). IWGDF qualitative frame: the of ulcers are purely neuropathic or neuro-ischaemic;

EURODIALE 4-stage classification by PAD ± infection at presentation

🟢 Verified · Registry audit 2026-11-06 · Pending triple review

🔄Flip the card — population, dispute & sources

PER-DFU-PROT-01 · Pressure-relieving therapeutic footwear (custom-made / demonstrated pressure relief, worn indoors + outdoors)

13.3% vs 25.4% · RR 0.49 (95% CI 0.28–0.84) · halves

Ulcer recurrence with usual footwear — , i.e. roughly recurrence

🟢 Verified · Registry audit 2026-11-06 · Pending triple review

🔄Flip the card — population, dispute & sources

PER-DFU-PROT-02 · The footwear effect is conditional on pressure relief + adherence

OR 2.33 · neither · and

Recurrence when condition was met (in-shoe peak pressure <200 kPa device adherence >80% of steps). Wearing the device is not enough — it must actually offload, and actually be worn

🟡 Qualified · Registry audit 2026-11-06 · Pending triple review

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PER-DFU-PROT-03 · Home foot-temperature monitoring (daily plantar temperature; act if >2.2 °C difference vs the other foot on 2 consecutive days)

Disputed — see D2. · 0.51 · RR 0.78 (0.57–1.08), p=0.133 — not significant · Adopted position: a real but adherence-dependent adjunct — never headline "halves your risk" unqualified

🔴 Pooled MA of 4 early RCTs: effect ≈ (95% CI 0.31–0.84; absolute recurrence 18.7% vs 30.8%). Largest pragmatic RCT (DIATEMP, n=304, 18 months): primary endpoint ; any-site recurrence RR 0.76 (0.58–1.00), p=0.046; the subgroup who actually reduced activity on a hotspot: RR 0.34 (0.11–0.99).

🔴 Disputed · Registry audit 2026-11-06 · Pending triple review

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PER-DFU-PROT-04 · Structured foot-care education alone

No adoptable protective number. · insufficient and inconsistent · Low

Cochrane (12 RCTs): education improves knowledge and short-term self-care behaviour, but evidence that *limited education alone* reduces ulcer incidence is — the one positive ulcer result (RR 0.31) came from a high-bias-risk trial, while the lower-bias-risk trial found RR 1.00 (0.70–1.44). IWGDF nonetheless recommends structured education as a component of care (Strong recommendation, certainty)

⚪ Qualitative · Registry audit 2026-11-06 · Pending triple review

🔄Flip the card — population, dispute & sources

PER-DFU-PROT-05 · Risk stratification + scheduled foot screening

Risk 0 · yearly · Risk 1 · 6–12-monthly · Risk 2 · 3–6-monthly · Risk 3 · 1–3-monthly · Honesty note: no RCT isolates screening itself as the intervention that reduces ulcer incidence

IWGDF system: (no LOPS/PAD) → screen ; (LOPS or PAD) → ; (LOPS+PAD, or either + deformity) → ; (LOPS or PAD + prior ulcer/amputation/end-stage renal disease) → . Population distribution of categories (JAMA, adapted from Stang & Leese): risk 0 ≈78.6%, risk 1 ≈14.2%, risk 2 ≈4.3%, risk 3 ≈1.8%. — screening works by triggering footwear, education and care intensity; IWGDF grades the stratification/prognosis evidence High, the downstream pathway is what carries the effect

🟢 Verified · Registry audit 2026-11-06 · Pending triple review

🔄Flip the card — population, dispute & sources

PER-DFU-PROT-06 · Integrated foot care (professional foot care + adequate footwear + structured education, repeated: 1–3-monthly if high risk, 3–6-monthly if moderate)

No single pooled ulcer-incidence figure verified · amputation · outside this dossier's scope and not quoted

recommended as a package by IWGDF (Strong; Low certainty). The components with numbers are carded separately above (footwear PROT-01; education PROT-04). The multidisciplinary-care effect most often quoted is an outcome and is therefore

⚪ Qualitative · Registry audit 2026-11-06 · Pending triple review

🔄Flip the card — population, dispute & sources

PER-DFU-REC-01 · Recurrence after healing

42% at 1 year · 58% at 3 years · 65% at 5 years

Any new ulcer after complete healing of the index ulcer (same or different site)

🟢 Verified · Registry audit 2026-11-06 · Pending triple review

🔄Flip the card — population, dispute & sources

PER-DFU-RISK-01 · Loss of protective sensation (LOPS)

Likelihood ratio 11–16 · OR 3.68

(a) for ulceration if insensate to the 5.07 monofilament; (b) for recurrence (Reiber et al., as charted in NEJM Fig. 3)

(a) Future ulceration — positive monofilament test; (b) ulcer recurrence

🟡 Qualified · Registry audit 2026-11-06 · Pending triple review

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PER-DFU-RISK-02 · PAD

OR 3.10 (95% CI 2.43–3.95)

Ulcer recurrence after healing

🟢 Verified · Registry audit 2026-11-06 · Pending triple review

🔄Flip the card — population, dispute & sources

PER-DFU-RISK-03 · Foot deformity

OR 2.51 (95% CI 1.85–3.40)

Ulcer recurrence

🟢 Verified · Registry audit 2026-11-06 · Pending triple review

🔄Flip the card — population, dispute & sources

PER-DFU-RISK-04 · Diabetic peripheral neuropathy

OR 1.78 (95% CI 1.45–2.19)

Ulcer recurrence

🟢 Verified · Registry audit 2026-11-06 · Pending triple review

🔄Flip the card — population, dispute & sources

PER-DFU-RISK-05 · Plantar location of the index ulcer

OR 2.44 (95% CI 1.41–4.23)

Ulcer recurrence

🟡 Qualified · Registry audit 2026-11-06 · Pending triple review

🔄Flip the card — population, dispute & sources

PER-DFU-RISK-06 · Previous foot ulcer (or amputation)

The strongest single predictor of ulceration · risk category 3 · remission, not cure

(NEJM, verbatim). Operationalised by IWGDF as — the category whose measured 1-year re-ulceration is ≈42% (see PER-DFU-REC-01). A healed ulcer =

Future ulceration

🟢 Verified · Registry audit 2026-11-06 · Pending triple review

🔄Flip the card — population, dispute & sources

PER-DFU-RISK-07 · Poor glycaemic control (HbA1c)

1.24 (1.05–1.46) · 1.98 (1.65–2.39) · 2.68 (2.13–3.37) · 4.52 (3.62–5.65)

Adjusted HR vs HbA1c 42–53 mmol/mol (6.0–7.0%): at 53–64 (7.0–8.0%) · at 64–75 (8.0–9.0%) · at 75–86 (9.0–10.0%) · at >86 (>10%). Risk rises steeply above 53 mmol/mol (7%)

First lower-limb ulcer incidence (dose–response)

🟡 Qualified · Registry audit 2026-11-06 · Pending triple review

🔄Flip the card — population, dispute & sources

PER-DFU-SUC-01 · Healing of neuropathic ulcers with good standard care

Split by population (Dispute D3): · 24.2% healed by 12 weeks (95% CI 19.5–28.8) · 30.9% by 20 weeks (26.6–35.1) · ≈30–40% healed at 12 weeks

🔴 defined neuropathic ulcers → and . Broader all-comer trial synthesis → . Adopted: Margolis for the neuropathic standard-care question; JAMA range quoted alongside, never merged

Complete healing by 12 and 20 weeks; standard care = debridement, dressings, pressure offloading, infection treatment as needed — no advanced adjuncts (trial control arms)

🔴 Disputed · Registry audit 2026-11-06 · Pending triple review

🔄Flip the card — population, dispute & sources

PER-DFU-SUC-02 · Healing by 1 year — and the PAD penalty

≈77% heal within 1 year · 84% without PAD vs 69% with PAD

overall; by perfusion: — ischaemia costs ~15 points of healing

Any healing within 1 year of presentation at specialist centres

🟡 Qualified · Registry audit 2026-11-06 · Pending triple review

🔄Flip the card — population, dispute & sources

PER-DFU-SUC-03 · Offloading device type and healing

81.9% vs 66.1% · RR 1.24 (95% CI 1.09–1.41) · 80–90%

Healing — favouring non-removable. Mechanism: TCC reduces plantar pressure by vs standard shoe; removable devices fail mainly on adherence (patients are active in the device for only ~28% of total activity in monitor studies)

Complete healing of plantar neuropathic ulcers; non-removable (TCC / irremovable walker) vs removable devices

🟢 Verified · Registry audit 2026-11-06 · Pending triple review

🔄Flip the card — population, dispute & sources