Pilot Implementation of a Thermography-Driven Preventive Foot Care Protocol for Diabetes-Related Foot Ulcers in Community Health Centers: Non-Randomized Controlled Trial.
Makoto Oe, Haryanto Haryanto, Kanae Mukai et al.
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In 30 seconds
This multicenter, non-randomized controlled trial assessed a thermography-driven preventive foot care protocol in people with diabetes attending two Indonesian community health centers. One center provided protocol-based care and the other standard education; 71 participants were enrolled in each group and monitored for one year. Ulceration occurred in 6 intervention participants and 8 controls, with no significant difference (p = 0.573). Time to ulceration was shorter in the intervention group (203.8 ± 8.7 vs 350.0 ± 13.9 days, p = 0.048). The authors concluded the protocol was ineffective in this setting.
Key findings
- Ulceration affected 6 intervention participants versus 8 controls; the difference was not significant (p = 0.573).
- Time to ulceration was 203.8 ± 8.7 vs 350.0 ± 13.9 days in the intervention and control groups, respectively (p = 0.048).
- Examination compliance was 100%, while compliance with callus and nail care was 0% over one-year follow-up.
- Participants without neuropathy or angiopathy also developed ulcers.
Why it matters
The findings highlight that introducing a preventive protocol in community settings may not translate into effective ulcer prevention when key care components are not implemented. Ulcers also occurred among participants without the specified risk factors, underscoring uncertainty about risk identification in this population. These results inform evaluation of both protocol design and practical delivery before effectiveness is tested more rigorously.
What to keep in mind
The non-randomized comparison used only two centers, with one center assigned to each care approach, so differences between centers may affect the results.