Chlorhexidine vs Routine Foot Washing to Prevent Diabetic Foot Ulcers: A Randomized Clinical Trial.

Summary

In a double-blind, placebo-controlled RCT of 175 high-risk veterans with diabetes, daily 2% chlorhexidine wipes did not reduce time to new foot complications versus soap-and-water wipes over 1 year. The intervention was well tolerated and adherence was high, with no product-related adverse events.

Key Findings

• No significant reduction in new foot complications with chlorhexidine vs control (12/88 [14%] vs 14/87 [16%]; HR 0.83, 95% CI 0.39–1.80).
• Median time to complication was 232 days (IQR 115–315) across groups.
• High adherence (83%) and no product-related adverse events over 1 year.

Clinical Implications

Routine use of chlorhexidine wipes for diabetic foot care should not be recommended solely for preventing ulcers, infection, or amputation; reinforce standard soap-and-water hygiene and comprehensive foot self-care education.

Limitations

• Single-center VA population limits generalizability
• Phase 2b with modest sample size may be underpowered for small effect sizes

Future Directions

Evaluate multifaceted foot-care interventions (education, offloading, footwear) and identify subgroups that might benefit from antiseptic strategies; explore pragmatic, multicenter designs.