David C. Lavery

Reducing Dynamic Foot Pressures in High-Risk Diabetic Subjects With Foot Ulcerations: A comparison of treatments

OBJECTIVE To compare the effectiveness of total contact casts, commercially available therapeutic shoes, and removable walking casts to reduce mean peak plantar foot pressures at the site of neuropathic ulcerations in diabetic subjects. RESEARCH DESIGN AND METHODS We compared the reduction in peak plantar pressures at ulcer sites under the great toe (n = 5), first metatarsal (n = 10), and second through fifth metatarsals (n = 10) using six treatments: total contact casts (TCCs), DH Pressure Relief Walkers (DH), Aircast Pneumatic Walkers, Three D Dura-Steppers (3D), CAM Walkers, and P.W. Minor Xtra Depth shoes. A rubber sole canvas oxford was used to establish baseline pressure values. The canvas oxford could be viewed as a worse-case scenario for this patient population. With the EMED Pedar in-shoe pressure measurement system, data for 40 steps were collected for each treatment. We used Tukeys Studentized Range Test for simultaneous multiple comparisons to compare treatments. RESULTS DH Pressure Relief Walkers reduced plantar pressures significantly better than other commercially available treatments for ulcers under the first metatarsal, second through fifth metatarsals, and great toe (P < 0.05). There was not a significant difference in mean peak plantar pressures between TCCs and DHs at any of the forefoot ulcer sites. CONCLUSIONS DH Pressure Relief Walkers were as effective as total contact casts to reduce foot pressures at ulcer sites and may be an effective practical addition in the treatment of foot ulcers.

Reducing Plantar Pressure in the Neuropathic Foot: A comparison of footwear

OBJECTIVE To compare the effectiveness of therapeutic, comfort, and athletic shoes with and without viscoelastic insoles. RESEARCH DESIGN AND METHODS We compared pressure reduction at ulcer sites under the hallux (n = 10), first metatarsal (n = 10), and lesser metatarsals (n = 12), using extra-depth, athletic, and comfort shoes with and without viscoelastic insoles. A rubber-soled canvas oxford was used to establish baseline pressure values. RESULTS When used in conjunction with a viscoelastic insole, all shoe types reduced mean peak plantar pressure better than their non-insoled counterparts (P < 0.05). Consistently, comfort shoes reduced pressure significantly better than both the cross trainers and extra-depth shoes for ulcers under the first and lesser metatarsals (P < 0.05). For each shoe type, the addition of the viscoelastic insole provided a significant reduction in mean peak pressure (P < 0.05). Compared with stock insoles, viscoelastic insoles reduced pressures an additional 5.4-20.1% at ulcer sites. The same trend was also observed at regions of the foot not associated with an ulceration. CONCLUSIONS When used in conjunction with a viscoelastic insole, both the comfort and athletic cross-trainer shoes studied were as, if not more, effective than commonly prescribed therapeutic shoes in reducing mean peak first and lesser metatarsal pressures. Furthermore, comfort shoes were as effective as therapeutic shoes in reducing pressure under the great toe. Both of these shoe types may be viable options to prevent the development or recurrence of foot ulcers.

Reevaluating the Way We Classify the Diabetic Foot Restructuring the diabetic foot risk classification system of the International Working Group on the Diabetic Foot

OBJECTIVE—To separately evaluate peripheral arterial occlusive disease (PAOD) and foot ulcer and amputation history in a diabetic foot risk classification to predict foot complications. RESEARCH DESIGN AND METHODS—We evaluated 1,666 diabetic patients for 27.2 ± 4.2 months. Patients underwent a detailed foot assessment and were followed at regular intervals. We used a modified version of the International Working Group on the Diabetic Foots (IWGDFs) risk classification to assess complications during the follow-up period. RESULTS—There were more ulcerations, infections, amputations, and hospitalizations as risk group increased (χ2 for trend P < 0.001). When risk category 2 (neuropathy and deformity and/or PAOD) was stratified by PAOD, there were more complications in PAOD patients (P < 0.01). When risk group 3 patients (ulceration or amputation history) were separately stratified, there were more complications in subjects with previous amputation (P < 0.01). CONCLUSIONS—We propose a new risk classification that predicts future foot complications better than that currently used by the IWGDF.

Re-evaluating How We Classify the Diabetic Foot: Restructuring the International Working Group's Diabetic Foot Risk Classification

OBJECTIVE—To separately evaluate peripheral arterial occlusive disease (PAOD) and foot ulcer and amputation history in a diabetic foot risk classification to predict foot complications. RESEARCH DESIGN AND METHODS—We evaluated 1,666 diabetic patients for 27.2 ± 4.2 months. Patients underwent a detailed foot assessment and were followed at regular intervals. We used a modified version of the International Working Group on the Diabetic Foots (IWGDFs) risk classification to assess complications during the follow-up period. RESULTS—There were more ulcerations, infections, amputations, and hospitalizations as risk group increased (χ2 for trend P < 0.001). When risk category 2 (neuropathy and deformity and/or PAOD) was stratified by PAOD, there were more complications in PAOD patients (P < 0.01). When risk group 3 patients (ulceration or amputation history) were separately stratified, there were more complications in subjects with previous amputation (P < 0.01). CONCLUSIONS—We propose a new risk classification that predicts future foot complications better than that currently used by the IWGDF.

Effectiveness of diabetic insoles to reduce foot pressures

The F-Scan system was used to measure peak plantar pressures in 11 diabetics each with a unilateral great toe amputation and an intact contralateral extremity (nonamputated), to evaluate the effectiveness of five footwear-insole strategies: 1) extra-depth shoes without an insole, 2) extra-depth shoes with a Plastizote insole, 3) extra-depth shoes with a Plastizote insole and a metatarsal pad, 4) extra-depth shoes with a Plastizote insole and a medial longitudinal arch pad, and 5) extra-depth shoes with a Plastizote insole and a combination of metatarsal pad and arch pad. When we compared extra-depth shoes with and without insoles, peak pressures were significantly reduced with insoles under the first metatarsal, the lesser metatarsals, and the heel (p < 0.001) in feet with and without an amputation, as well as under the great toe on the contralateral foot (nonamputated, p < 0.001), but not under the lesser toes (giant toe, p = 0.088; nonamputated, p = 0.763). There was no significant difference between the different insole modifications.

Impact of Chronic Kidney Disease on Survival After Amputation in Individuals With Diabetes

OBJECTIVE To identify factors that influence survival after diabetes-related amputations. RESEARCH DESIGN AND METHODS We abstracted medical records of 1,043 hospitalized subjects with diabetes and a lower-extremity amputation from 1 January to 31 December 1993 in six metropolitan statistical areas in south Texas. We identified mortality in the 10-year period after amputation from death certificate data. Diabetes was verified using World Health Organization criteria. Amputations were identified by ICD-9-CM codes 84.11–84.18 and categorized as foot, below-knee amputation, and above-knee amputation and verified by reviewing medical records. We evaluated three levels of renal function: chronic kidney disease (CKD), hemodialysis, and no renal disease. We defined CKD based on a glomerular filtration rate <60 ml/min and hemodialysis from Current Procedural Terminology (CPT) codes (90921, 90925, 90935, and 90937). We used χ2 for trend and Cox regression analysis to evaluate risk factors for survival after amputation. RESULTS Patients with CKD and dialysis had more below-knee amputations and above-knee amputations than patients with no renal disease (P < 0.01). Survival was significantly higher in patients with no renal impairment (P < 0.01). The Cox regression indicated a 290% increase in hazard for death for dialysis treatment (hazard ratio [HR] 3.9, 95% CI 3.07–5.0) and a 46% increase for CKD (HR 1.46, 95% CI 1.21–1.77). Subjects with an above-knee amputation had a 167% increase in hazard (HR 2.67, 95% CI 2.14–3.34), and below-knee amputation patients had a 67% increase in hazard for death. CONCLUSIONS Survival after amputation is lower in diabetic patients with CKD, dialysis, and high-level amputations.

Total contact casts: Pressure reduction at ulcer sites and the effect on the contralateral foot

OBJECTIVE To compare the effectiveness of total contact casts with a cast boot (TCCB), total contact casts with a cast heel (TCCH), and therapeutic XtraDepth shoes (XDS) to reduce ulcer site pressures and to determine if total contact casts increase contralateral pressures. DESIGN Repeat measure design with 40 replications nested within each treatment for each patient. METHODS Peak contralateral foot pressures and ulcer site pressures under the 1st metatarsal (1MET; n = 10), 2nd to 5th metatarsals (2-5MET; n = 10), and great toe (GT; n = 5) were compared using the Novel-Pedar system and three treatments: TCCB, TCCH, and XDS. Baseline pressures were established using canvas oxfords. RESULTS There was no difference in pressure reduction with TCCH vs. TCCB for 1MET or GT ulcers, but TCCH reduced pressure better for 2-5MET ulcers (p < .001). Contralateral pressures were not elevated in either TCC group. CONCLUSIONS TCCH were superior to TCCB in reducing 2-5MET ulcer pressures and equivalent to TCCB for 1MET and GT ulcers. Contralateral pressures are not increased by TCC use.

Does Anodyne Light Therapy Improve Peripheral Neuropathy in Diabetes? A double-blind, sham-controlled, randomized trial to evaluate monochromatic infrared photoenergy

OBJECTIVE—The purpose of this study was to determine the efficacy of anodyne monochromatic infrared photo energy (MIRE) in-home treatments over a 90-day period to improve peripheral sensation and self-reported quality of life in individuals with diabetes. RESEARCH DESIGN AND METHODS—This was a double-blind, randomized, sham-controlled clinical trail. We randomly assigned 69 individuals with diabetes and a vibration perception threshold (VPT) between 20 and 45 V to two treatment groups: active or sham treatment. Sixty patients (120 limbs) completed the study. Anodyne units were used at home every day for 40 min for 90 days. We evaluated nerve conduction velocities, VPT, Semmes-Weinstein monofilaments (SWM) (4-, 10-, 26-, and 60-g monofilaments), the Michigan Neuropathy Screening Instrument (MNSI), a 10-cm visual analog pain scale, and a neuropathy-specific quality of life instrument. We used a nested repeated-measures multiple ANOVA design. Two sites (great toe and fifth metatarsal) were tested on both the left and right feet of each patient, so two feet were nested within each patient and two sites were nested within each foot. To analyze the ordinal SWM scores, we used a nonparametric factorial analysis for longitudinal data. RESULTS—There were no significant differences in measures for quality of life, MNSI, VPT, SWM, or nerve conduction velocities in active or sham treatment groups (P > 0.05). CONCLUSIONS—Anodyne MIRE therapy was no more effective than sham therapy in the treatment of sensory neuropathy in individuals with diabetes.

Cost of diabetes-related amputations in minorities

The objective of this study was to identify the direct cost and length of hospitalization of diabetes-related lower extremity amputations among Hispanics, African Americans, non-Hispanic whites, and Asians. The authors used a database from the office of Statewide Planning and Development in California that identified all hospitalizations for lower extremity amputations in the state in 1991. Amputation level was defined by the ICD-9-CM codes 84.11-84.18. The total hospital charges for diabetes-related lower extremity amputations for the state of California in 1991 was

A quantitative assessment of healing sandals and postoperative shoes in offloading the neuropathic diabetic foot.

141 million. The mean hospital charge (HC) per patient with all ethnic groups combined was