A single arm prospective feasibility study evaluating wound closure with a unique wearable device that provides intermittent plantar compression and offloading in the treatment of non-healing diabetic foot ulcers.

The incidence and economic burden of diabetic foot ulcers continues to rise throughout the world. In this prospective study, a unique device designed to offload the wound, enhance circulation and monitor patient compliance was evaluated for safety and efficacy. The device provides offloading and intermittent plantar compression to improve the pedal flow of oxygenated blood and support wound healing while recording patient use. Ten patients with non-healing diabetic foot ulcers UTgrade 1A/Wagner grade 1 were treated weekly for up to 12 weeks. The primary endpoint was complete wound closure at 12 weeks, and secondary endpoints included healing time, percent area reduction and changes in pain using the visual analogue pain scale. Eight out of ten wounds healed within 12 weeks(80%), and the mean healing time was 41 days(95% CI:24.3-58.3). The percent area reduction was 75(SD:53.9). The baseline visual analogue pain scale was 4.5(2.9) as compared with 3.3(3.4) at end of study. No device-related or serious adverse events were reported. This unique intermediate plantar compression and offloading device may be considered as an alternative for safe and effective for treatment of non-healing diabetic foot ulcers. During treatment, wound healing was significantly accelerated, and pain was improved. Larger randomised controlled trials are underway to validate these early findings.

Vertical Wire Forefoot Fixation: An Advanced Technique for the Dynamic External Fixation Apparatus.

External fixation is used for the correction of select foot and ankle deformities. We have found the traditional forefoot crossing wire technique to be insufficient in terms of both individual metatarsal control and forefoot manipulation when using a dynamic ring fixator to correct forefoot deformities. We developed a forefoot fixation technique at the University of Cincinnati Medical Center, using 5 vertical wires to gain greater forefoot control while performing more precise skeletal manipulation for multiplanar deformity correction. The associated risks of infection, neurovascular injury, and other soft-tissue injury should be further investigated. This proposed vertical wire construct is an advanced method with which the foot and ankle surgeon can correct complex lower limb deformities.