Smart pressure-sensing insoles,
does it really help with Reduced recurrence of healed plantar diabetic foot ulcers?
research showsThe grade is C with 54 points. In an 18-month proof-of-concept randomized trial, the alert group had four ulcers over 11,835 person-days versus ten over 8,638 person-days without alerts, incidence rate ratio 0.29 (95% CI 0.09-0.93). However, only 58 of 90 randomized participants entered the main analysis, and the proportion of people with at least one ulcer, 4/32 versus 6/26, was not significantly different.
ads claimA sensor recording pressure and issuing alerts is a device fact; fewer clinical ulcers is a separate efficacy claim. The comparator used the same insole without alerts, not no device.
Useful facts when choosing a product
- Each insole had eight pressure sensors sampling at 8 Hz.
- Accumulated pressure at or above 35 mmHg triggered audiovisual and vibration alerts with offloading instructions.
- Alert operation and ulcer prevention are different claims; two independent masked experts verified ulcers from photographs.
Chamgap Semantic Classification Code
Candidate index · review held
UNK.continuous-plantar-pressure-sensing-insoles-with-smartwatch-alerts-and-offloading-guidance.UNK.recurrence-of-healed-plantar-diabetic-foot-ulcers.reduce.UNKUnknown > Continuous plantar-pressure sensing insoles with smartwatch alerts and offloading guidance > Unknown > recurrence of healed plantar diabetic foot ulcers > Reduction claim > Unknown
An automated migration candidate, not an issued permanent code; exact claim scope remains under review. This machine-generated migration candidate helps retrieval but is not a permanent assignment. The original verdict ID and URL remain authoritative.
What the research actually shows
Abbott and colleagues randomized 90 patients with recently healed plantar ulcers and peripheral neuropathy at two UK diabetic-foot clinics. Both groups wore SurroSense Rx; only the intervention group received audiovisual and vibration alerts plus offloading instructions when pressure above 35 mmHg accumulated. Monthly clinicians and two photograph reviewers were masked, while the Poisson analysis used follow-up accrued by the 58 participants who entered the study analysis.
Why this is classified as C (54)
Ulcer-event incidence fell, but major attrition from 90 randomized to 58 analyzed and a sample below 200 impose a C ceiling, giving 54 points.
Counterpoint. This verdict applies to high-risk patients with a recently healed plantar ulcer and neuropathy, not general gait-analysis insoles or primary ulcer prevention.
Rejudgment record. Cross-check applied — Cross-checked the primary endpoint, 90 randomized versus 58 analyzed, incidence-rate and patient-level results, funding, and masking against the article and registry
| Endpoint | H | Hard endpoint - actual events such as death |
| Replication | R1 | Single confirmatory trial |
| Independence | I1 | Mixed funding sources |
| Effect size | E+ | Meets the clinically important threshold |
Stored derived and displayed grades match; this is not a current recalculation or validity check (C).
Sub-claim grades by effect
This ingredient is marketed for several effects. A single overall grade blends strong and weak claims together, so each effect is graded separately here. The overall grade reflects the strongest disconfirming or core claim.
| Effect (sub-claim) | Grade | Basis |
|---|---|---|
| Smartwatch alerts reduce recurrent plantar-ulcer event incidence | C | The incidence rate ratio was 0.29, but only 58 of 90 randomized participants were analyzed. |
| Smartwatch alerts reduce the number of patients with any recurrence | D | The difference, 4/32 versus 6/26, was not significant, P=0.29. |
Cross-check — AI research and Codex final gate
Evidence Table
| Study | Design | Sample | Funding | Endpoint | Result | Weight |
|---|---|---|---|---|---|---|
| Abbott CA et al. 2019 intelligent-insole trial | Two-clinic single-masked randomized proof-of-concept trial | 90 randomized; 58 in the main analysis, 32 alert and 26 no-alert | Diabetes UK funded the first three years; Orpyx Medical Technologies funded the final year, a researcher salary, and technical support | Plantar-ulcer recurrence over 18 months, counted as events and affected patients | Four events/11,835 person-days versus ten/8,638, IRR 0.29 (95% CI 0.09-0.93); affected patients 4/32 versus 6/26, P=0.29 | Only direct clinical trial |
Receipt — 1 References
All 1 cited sources were verified for existence at the original page (as of 2026-08-14).
Final verification and publication gate: Codex · Evidence date: 2026-08-14 · Corrections: none
Cite this verdict
[Chamgap] Smart pressure-sensing insoles x recurrent plantar diabetic foot ulcers — Evidence Grade C·54. 1 cited sources checked. Source: https://chamgap.com/en/verdicts/blood-sugar/smart-pressure-insole-diabetic-foot-ulcer-recurrence/ · CC BY 4.0CC BY 4.0 — free to use with attribution; do not distort grades, numbers, or verdict meaning.
What this document does and does not do
Chamgap is an information source. It reports what research has and has not confirmed; it does not tell readers what to take or buy. That decision belongs to readers and, when needed, medical or legal professionals. This verdict reflects literature available up to the search date and may change as new research appears. Nothing here is medical advice.