Personalized Offloading Treatments for Healing Plantar Diabetic Foot Ulcers

Abstract

Background: Non-removable knee-high devices are the gold-standard offloading treatments to heal plantar diabetic foot ulcers (DFUs). These devices are underused in practice for a variety of reasons. Recommending these devices for all patients, regardless of their circumstances and preferences influencing their ability to tolerate the devices, does not seem a fruitful approach. Purpose: The aim of this article is to explore the potential implications of a more personalized approach to offloading DFUs and suggest avenues for future research and development. Methods: Non-removable knee-high devices effectively heal plantar DFUs by reducing plantar pressure and shear at the DFU, reducing weight-bearing activity and enforcing high adherence. We propose that future offloading devices should be developed that aim to optimize these mechanisms according to each individual’s needs. We suggest three different approaches may be developed to achieve such personalized offloading treatment. First, we suggest modular devices, where different mechanical features (rocker-bottom sole, knee-high cast walls/struts, etc.) can be added or removed from the device to accommodate different patients’ needs and the evolving needs of the patient throughout the treatment period. Second, advanced manufacturing techniques and novel materials could be used to personalize the design of their devices, thereby improving common hindrances to their use, such as devices being heavy, bulky, and hot. Third, sensors could be used to provide real-time feedback to patients and clinicians on plantar pressures, shear, weight-bearing activity, and adherence. Conclusions: By the use of these approaches, we could provide patients with personalized devices to optimize plantar tissue stress, thereby improving clinical outcomes.

Effectiveness of offloading interventions for people with diabetes‐related foot ulcers: A systematic review and meta‐analysis

“…Fifth, whilst some new controlled studies came from low‐to‐middle income countries 34,38 or those with hotter climates, 34,84 there is still a need for more trials in those settings, including developing and trialing lighter, cooler and less expensive devices, without losing the key mechanical offloading features of existing devices 12,188 …”

“…Second, while all removable devices are likely inferior to non‐removable devices due to lower adherence, 46,187 and different removable devices may make little difference to healing compared with each other, they also seem to have different benefits on other outcomes that if harnessed collectively may improve healing. Thus, we recommend more high‐quality trials are needed to determine which removable devices are most effective at maximising the collective benefits on plantar pressure, adherence and satisfaction, such as existing removable devices, new smart devices or combination interventions of different devices with psychological interventions 12,188–191 …”

“…Second, while all removable devices are likely inferior to nonremovable devices due to lower adherence, 46,187 Fifth, whilst some new controlled studies came from low-tomiddle income countries 34,38 or those with hotter climates, 34,84 there is still a need for more trials in those settings, including developing and trialing lighter, cooler and less expensive devices, without losing the key mechanical offloading features of existing devices. 12,188 Sixth, although for the first time we were able to pool various important outcomes, the certainty of evidence for these outcomes was nearly always (very) low. Thus, we continue to recommend that future trials report these other important outcomes, consistent with international standards, so as to continue to be able to pool the effects for these important outcomes in future.…”

Guidelines on offloading foot ulcers in persons with diabetes (IWGDF 2023 update)

“…7,53 If such combined plantar tissue stress measures are able to detect objective thresholds for effective healing, this may enable the development of future smart offloading treatments designed to meet such threshold targets. 53,54 4. In developing the recommendations for this guideline, we have made an overall judgement that a reduction in weight bearing activity is beneficial to ulcer healing based on one other review 37 and our expert opinion.…”

“…While we acknowledge based on the above evidence provided that more high‐quality RCTs on the primary outcome of ulcer healing are needed, the focus can be strengthened by measuring the factors impacting on the mechanical tissue stress levels that lead to different healing outcomes, such as plantar pressure, shear stress, weight‐bearing activity (including steps and standing duration), and adherence to using offloading interventions or a combined plantar tissue stress measure 7,53 . If such combined plantar tissue stress measures are able to detect objective thresholds for effective healing, this may enable the development of future smart offloading treatments designed to meet such threshold targets 53,54 In developing the recommendations for this guideline, we have made an overall judgement that a reduction in weight bearing activity is beneficial to ulcer healing based on one other review 37 and our expert opinion.…”