We sought to evaluate the relationship between baseline hemoglobin A1c (HbA1c) level and clinical outcomes, including foot ulcer outcome (resolved versus unresolved) and wound-healing time, in individuals with type 2 diabetes.
A prospective observational study was conducted on 99 patients presenting with a diabetic foot ulceration. Patient and ulcer characteristics were recorded. Patients were followed up for a maximum of 1 year.
After 1 year of follow-up, 77% of ulcers healed and 23% did not heal. Although this study demonstrated that the baseline HbA1c reading was not a significant predictor of foot ulcer outcome (P = .603, resolved versus amputated), on further statistical analyses, when HbA1c was compared with the time taken for complete ulcer healing in the resolved group (n = 77), it proved to be significant (P = .009).
These findings have important implications for clinical practice, especially in an outpatient setting. Improving glycemic control may improve ulcer outcomes. Prediction of outcome may be helpful for health-care professionals in individualizing and optimizing clinical assessment and management of patients. Identification of determinants of outcome could result in improved health outcomes, improved quality of life, and fewer diabetes-related foot complications.
Selecting empirical therapy for a diabetic foot infection (DFI) requires knowing how likely infection with Pseudomonas aeruginosa is in a particular patient. We designed this study to define the risk factors associated with P aeruginosa in DFI.
We performed a preplanned microbiological subanalysis of data from a study assessing the effects of treatment with intralesional epidermal growth factor for diabetic foot wounds in patients in Turkey between January 1, 2012, and December 31, 2013. Patients were screened for risk factors, and the data of enrolled individuals were recorded in custom-designed patient data forms. Factors affecting P aeruginosa isolation were evaluated by univariate and multivariate logistic regression analyses, with statistical significance set at P < .05.
There were 174 patients enrolled in the main study. Statistical analysis was performed in 90 evaluable patients for whom we had microbiological assessments. Cultures were sterile in 19 patients, and 89 bacterial isolates were found in the other 71. The most frequently isolated bacteria were P aeruginosa (n = 23, 25.8%) and Staphylococcus aureus (n = 12, 13.5%). Previous lower-extremity amputation and a history of using active wound dressings were the only statistically significant independent risk factors for the isolation of P aeruginosa in these DFIs.
This retrospective study provides some information on risk factors for infection with this difficult pathogen in patients with DFI. We need prospective studies in various parts of the world to better define this issue.
Charcot's neuroarthropathy (CN) treatment is still controversial, and the results are controversial. Owing to patient comorbidities, surgical intervention carries a high risk of complications. Thus, foreseeing the possible results of planned treatment is crucial. We retrospectively evaluated the Charcot Reconstruction Preoperative Prognostic Score (CRPPS) in patients with surgically treated CN.
Twenty-two feet of 20 patients were included in the study. Two groups were formed according to their CRPPS. Twelve patients with values less than 4 were defined as group A, and eight patients with values of 4 or greater were defined as group B. Mean follow-up was 61 months (range, 5–131 months). Groups were compared according to American Orthopaedic Foot and Ankle Society (AOFAS) scores, Foot and Ankle Disability Index (FADI) scores, and complication rates.
Group A and B mean AOFAS scores were 76.83 (range, 71–85) and 70.5 (range, 20–85), respectively. All of the patients were improved according to AOFAS and FADI scores, but no correlation was found with the CRPPS. None of the group A patients required additional intervention, but five patients in group B underwent revision surgery. No amputations were performed.
The CRPPS is focused on feasibility. The data needed to fill the scoring system is easily obtainable from medical records even retrospectively, and the score is helpful to predict a patient's outcome after CN-related surgery. Herein, CRPPS values of 4 or greater were related to high complication rates and lower functional outcomes.
Evaluating Iatrogenic Complications of the Total-Contact Cast
An 8-Year Retrospective Review at Cleveland Clinic
Background: Total-contact casting is an effective method to treat various pathologic abnormalities in patients with diabetic neuropathy, but its use is frequently associated with iatrogenic complications.
Methods: The largest retrospective review to date of iatrogenic complications of total-contact casts was conducted over an 8-year period at Cleveland Clinic.
Results: In the past 8 years, 23% of patients developed complications, and the most common complication was a new heel ulcer formation. Of these complications, 92.1% resolved, 6.4% were lost to follow-up, and 1.4% resulted in a partial foot amputation. Mean cast duration was 10.3 days for patients who developed a total-contact cast iatrogenic complication. The most common indication for the use of a total-contact cast was a neuropathic foot ulceration.
Conclusions: The results of this study support the use of total-contact casting in the insensate patient with diabetes. However, adequate staff training in total-contact cast application is recommended to reduce complications.
Retrograde intramedullary nailing for tibiotalocalcaneal arthrodesis (TTCA) is used for severe hindfoot deformities, end-stage arthritis, and limb salvage. The procedure is technically demanding, with complications such as infection, hardware failure, nonunion, osteomyelitis, and possible limb loss or death. This study reports the outcomes and complications of patients undergoing TTCA with a femoral nail, which is widely available and offers an extensive range of lengths and diameters.
We performed a retrospective review of 104 patients who underwent 109 TTCAs using a femoral nail as the primary procedure (January 2006 through December 2016). Demographic data, risk factors, and outcomes were evaluated.
At final follow-up, the overall clinical union rate was 89 of 109 (81.7%). Diabetes mellitus was negatively associated with limb salvage (P = .03), and peripheral neuropathy (P = .02) and Charcot's neuroarthropathy (P = .03) were negatively associated with clinical union. Only four patients (3.8%) underwent proximal amputation, at an average of 6.1 months, and 11 patients (10.6%) died, at a mean of 38.0 months. The most common complication was ulceration in 27 of 109 limbs (24.8%), followed by infection in 25 (22.9%). Twenty-three patients (22.1%) underwent revision procedures, at a mean of 9.4 months. Thirteen of these 23 patients (56.5%) had antibiotic cement rod spacers/rods for deep infection–related complications.
Use of a femoral nail has been shown to provide similar outcomes and limb salvage rates compared with other methods of TTCA reported for similar indications in the literature.
A Pragmatic, Single-Center, Prospective, Randomized Controlled Trial of Adjunct Hemoglobin-Mediated Granulox Topical Oxygen Therapy Twice Weekly for Foot Ulcers
Results of the Hemoglobin Application to Wounds Study
Achieving timely healing of foot ulcers can help avoid complications such as infection and amputation; topical oxygen therapy has shown promise in achieving this. We evaluated the clinical effectiveness of Granulox, a hemoglobin spray device designed to deliver oxygen to the surface of wounds, for the healing of foot ulcers.
We conducted a single-center, prospective, randomized controlled trial comparing standard of care (once-weekly podiatric medical clinic visits) versus standard care plus adjunct Granulox therapy twice weekly in adults with foot ulcers. After a 2-week screening phase, patients in whom the index wound had healed by less than 50% were randomized 1:1. Outcome measures were collated during the trial phase at 6 and 12 weeks.
Of 79 patients enrolled, 38 were randomized. After 12 weeks, the median percentage wound size reduction compared with the size of the ulcer at the start of the trial phase was 100% for the control arm and 48% for the Granulox arm (P = .21, Mann-Whitney U test). In the former, eight of 14 foot ulcers had healed; in the latter, four of 15 (P = .14, Fisher exact test). In the control arm, two amputations and one withdrawal occurred, whereas in the Granulox arm, one unrelated death and five withdrawals were recorded.
We could not replicate the favorable healing associated with use of Granulox as published by others. Differences in wound chronicity and frequency of Granulox application might have influenced differences in study results. Granulox might perform best when used as an adjunct for treatment of chronic wounds at least 8 weeks old.
Background: We sought to study the impact of foot complications on 10-year mortality independent of other demographic and biological risk factors in a racially and socioeconomically diverse managed-care population with access to high-quality medical care.
Methods: We studied 6,992 patients with diabetes in Translating Research Into Action for Diabetes (TRIAD), a prospective observational study of diabetes care in managed care. Foot complications were assessed using administrative claims data. The National Death Index was searched for deaths across 10 years of follow-up (2000-2009).
Results: Charcot's neuro-osteoarthropathy and diabetic foot ulcer with debridement were associated with an increased risk of mortality; however, the associations were not significant in fully adjusted models. Lower-extremity amputation (LEA) was associated with an increased risk of mortality in unadjusted (hazard ratio [HR], 3.21; 95% confidence interval [CI], 2.50–4.12) and fully adjusted (HR, 1.84; 95% CI, 1.28–2.63) models. When we examined the associations between LEA and mortality stratified by sex and race, risk was increased in men (HR, 1.96; 95% CI, 1.25–3.07), Hispanic individuals (HR, 5.17; 95% CI, 1.48–18.01), and white individuals (HR, 2.18; 95% CI, 1.37–3.47). In sensitivity analyses, minor LEA tended to increase the risk of mortality (HR, 1.48; 95% CI, 0.92–2.40), and major LEA was associated with a significantly higher risk of death at 10 years (HR, 1.89; 95% CI, 1.18–3.01).
Conclusions: In this managed-care population with access to high-quality medical care, LEA remained a robust independent predictor of mortality. The association was strongest in men and differed by race.
Osteomyelitis secondary to diabetic foot infections can lead to proximal amputation if not diagnosed in a timely and accurate manner. The authors have found no studies to date that correlate a specific erythrocyte sedimentation rate with osteomyelitis. A retrospective chart review of 29 diabetic patients admitted to the hospital with diagnoses of osteomyelitis or cellulitis of the foot during a 1-year period was performed. Of the various lab values and demographic factors compared, erythrocyte sedimentation rate was the only measure that differed significantly between the two groups. A receiver operating characteristic curve was used to obtain the optimal cutoff value of 70 mm/h, a level above which osteomyelitis was present with the highest sensitivity (89.5%) and highest specificity (100%), along with a positive predictive value of 100% and a negative predictive value of 83%. This study shows that in combination with clinical suspicion in diabetic foot infections, the erythrocyte sedimentation rate is highly predictive of osteomyelitis, and that the value of 70 mm/h is the optimal cutoff to predict accurately the presence or absence of bone infection. (J Am Podiatr Med Assoc 91(9): 445-450, 2001)
Giant cell tumors are benign tumors that are locally aggressive and rare in the foot. Giant cell tumors involving bone in the foot have an incidence of 1.2% to 2.8%, whereas giant cell tumors of the tendon sheath constitute 3% to 5% of all giant cell tumors in the foot and ankle. We present a case of giant cell tumor of the soft tissue disguised as a giant cell tumor of bone in a healthy 29-year-old male patient. Through radiographic and magnetic resonance imaging evaluation, it was determined that this patient had a bone tumor invading the distal and proximal phalanges of his left great toe with the involvement of soft tissue. With the use of the evidence-based medicine and patient expectation, the decision was made to amputate the digit. To much surprise, when the histopathologic results were reviewed, it was determined that the excised lesion was consistent with giant cell tumor of soft tissue that did not involve the bone.
Improved Sensitivity in Patients with Peripheral Neuropathy
Effects of Monochromatic Infrared Photo Energy
The medical records of 1,047 patients (mean age, 73 years) with established peripheral neuropathy were examined to determine whether treatment with monochromatic infrared photo energy was associated with increased foot sensitivity to the 5.07 Semmes-Weinstein monofilament. The peripheral neuropathy in 790 of these patients (75%) was due to diabetes mellitus. Before treatment with monochromatic infrared photo energy, of the ten tested sites (five on each foot), a mean ± SD of 7.9 ± 2.4 sites were insensitive to the 5.07 Semmes-Weinstein monofilament, and 1,033 patients exhibited loss of protective sensation. After treatment, the mean ± SD number of insensate sites on both feet was 2.3 ± 2.4, an improvement of 71%. Only 453 of 1,033 patients (43.9%) continued to have loss of protective sensation after treatment. Therefore, monochromatic infrared photo energy treatment seems to be associated with significant clinical improvement in foot sensation in patients, primarily Medicare aged, with peripheral neuropathy. Because insensitivity to the 5.07 Semmes-Weinstein monofilament has been reported to be a major risk factor for diabetic foot wounds, the use of monochromatic infrared photo energy may be associated with a reduced incidence of diabetic foot wounds and amputations. (J Am Podiatr Med Assoc 95(2): 143–147, 2005)