Efficacy and Mechanism of Orthotic Devices to Unload Metatarsal Heads in People With Diabetes and a History of Plantar Ulcers

Abstract

Total-contact inserts (TCIs) and metatarsal pads (MPs) frequently are prescribed to reduce excessive plantar stresses to help prevent skin breakdown in people with diabetes mellitus (DM) and peripheral neuropathy. The first purpose of this study was to determine the effect of a TCI and an MP on metatarsal head peak plantar pressures (PPP) and pressure-time integrals (PTI). The second purpose of this study was to determine a possible mechanism of pressure reduction by measuring contact area and loaded soft-tissue thickness (STT) under the metatarsal heads and second metatarsal shaft. Twenty subjects (12 men and 8 women; age [mean+/-SD]=57+/-9 years) with DM (duration [mean+/-SD]=16+/-11 years), peripheral neuropathy, and a history of plantar ulcers participated. A repeated-measures research design was used, and outcome measures are reported for 3 footwear conditions: shoe, shoe with TCI, and shoe with TCI and MP. In-shoe plantar pressures were collected during walking and during spiral x-ray computed tomography (SXCT). The STT and identification of the pressure sensor and location of the MP in relationship to the metatarsal heads were determined by use of SXCT. The PPP and the PTI were 16% to 24% lower at the metatarsal heads in the TCI condition than in the shoe condition. The PPP and the PTI decreased an additional 15% to 28% (for a total reduction of 29% to 47%) with the addition of the MP. The contact area increased 27% with the TCI but not with the MP. The STT did not increase under the metatarsal heads in the TCI condition (compared with the shoe condition) but did increase 8% to 22% at metatarsal heads 2 to 5 with the addition of the MP. The PPP increased substantially (308%) and the STT decreased 14% under the shaft of the second metatarsal with the addition of the MP to the TCI-plus-shoe condition. The TCI and the MP caused substantial and additive reductions of pressures under the metatarsal heads. The TCI reduces excessive pressures at the metatarsal heads by increasing the contact area of weight-bearing forces. Conversely, the MP acts by compressing the soft tissues proximal to the metatarsal heads and relieving compression at the metatarsal heads. These findings can assist in the design of effective orthotic devices to relieve excessive plantar stresses that contribute to skin breakdown and subsequent amputation in people with DM and peripheral neuropathy.