One of the persistent paradoxes in diabetic foot prevention is simple:
The world’s best protective shoe does no good while sitting beside the door.
Now, an important multicenter randomized controlled trial from our longtime Dutch friends and colleagues—led by Lisa Vossen with Jaap van Netten, Sicco Bus, and their team—shows that footwear adherence can be meaningfully improved when we stop treating the shoe as a solitary device and begin treating it as part of a personalized system.
From prescribing footwear to designing adherence
The DIASSIST trial randomized 126 people with diabetes, peripheral neuropathy, a previous foot ulcer, and custom-made footwear to either usual guideline-based care or an enhanced multimodal intervention.
The enhanced program combined:
- Pressure-optimized custom-made footwear
- Custom-made footwear specifically designed for indoor use
- Structured patient education
- Motivational interviewing with personalized feedback
Adherence was measured objectively as the percentage of steps taken while wearing the prescribed footwear—not merely by asking participants whether they wore it.
The results walked the walk
At six months, participants receiving enhanced treatment wore their prescribed footwear for 75% of their steps, compared with 56% in the usual-care group—a 34% relative improvement.
At 12 months, adherence remained significantly higher, although the difference narrowed: 58% versus 49%.
Daily shoe-wearing time also increased after structured education and rose particularly clearly after indoor-specific footwear was provided—from 7.7 to 9.4 hours per day.
The home may be the missing treatment room
That indoor-footwear finding may be the most intuitively important element.
Many people remove their protective footwear when they enter the home—precisely where they may accumulate thousands of unprotected steps. Prescribing a technically excellent outdoor shoe without addressing indoor behavior is a little like prescribing an antihypertensive that can only be taken at the office.
The intervention worked because it moved beyond telling people what they should do. It changed what they could comfortably and realistically do.
A research arc more than a decade in the making
We have followed this evolving work on the blog for years:
- In 2012: Let’s Measure What We Manage—using plantar-pressure assessment to improve diabetic footwear prescriptions.
- In 2013: People with diabetes were found to substantially underuse their prescribed footwear.
- In 2023: The Fragile Feet–Trivial Trauma model offered a clearer way to communicate ulcer risk and prevention.
- In 2025: The preliminary DIASSIST work showed the short-term promise of this multimodal approach.
- Also in 2025: The team challenged us to look beyond a single plantar-pressure number when evaluating footwear.
This is what sustained translational research looks like: identify the mechanical problem, measure the behavioral gap, redesign the device, redesign the message, and then test the entire package in a rigorous clinical trial.
The larger lesson
Adherence should not automatically be framed as a character trait—or as a failure by the person living with diabetes.
Frequently, adherence is an outcome of design.
Was the footwear comfortable? Was it easy to put on? Did it work inside the home? Did the person understand the reason for wearing it? Did anyone provide objective feedback? Was the intervention designed around the patient’s actual day—or around our imaginary version of it?
The primary endpoint here was adherence rather than ulcer recurrence, and because the intervention was delivered as an integrated package, the trial cannot completely untangle the independent contribution of every component. The reduction in effect by 12 months also tells us that reinforcement and continued adaptation will probably be necessary. Nevertheless, the objective adherence measurements, multicenter design, and randomized comparison make this a highly consequential contribution.
Bottom line
Custom footwear should not be regarded as a product handed to someone at the end of an appointment.
It is a biomechanical-behavioral service requiring pressure optimization, indoor and outdoor usability, education, feedback, and longitudinal follow-up.
Congratulations to Lisa Vossen, Jaap van Netten, Sicco Bus, and the entire DIASSIST team. This is thoughtful, practical science—and another important step toward helping people accumulate more ulcer-free, hospital-free, activity-rich days.
Reference
Vossen LE, Van Netten JJ, Hulshof CM, Jelsma N, Slootman A, Merkx MJM, Bus SA. An Integrated Personalized Multimodal Intervention Improves Adherence to Wearing Custom-Made Footwear in People With Diabetes at High Foot Ulcer Risk: A Multicenter Randomized Controlled Trial (DIASSIST). Diabetes Care. 2026;49:1384–1394. doi:10.2337/dc25-3113.
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