Infrared Thermography Shows That a Temperature Difference of 2.2°C (4°F) or Greater Between Corresponding Sites of Neuropathic Feet Does Not Always Lead to a Diabetic Foot Ulcer.

BACKGROUND: There is emerging interest in the application of foot temperature monitoring as means of diabetic foot ulcer (DFU) prevention. However, the variability in temperature readings of neuropathic feet remains unknown. The aim of this study was to analyze the long-term consistency of foot thermograms of diabetic feet at the risk of DFU. METHODS: A post-hoc analysis of thermal images of 15 participants who remained ulcer-free during a 12-month follow-up were unblinded at the end of the trial. Skin foot temperatures of 12 plantar, 15 dorsal, 3 lateral, and 3 medial regions of interests (ROIs) were derived on monthly thermograms. The temperature differences (∆Ts) of corresponding ROIs of both feet were calculated. RESULTS: Over the 12-month study period, out of the total 2026 plantar data points, 20.3% ROIs were rated as abnormal (absolute ∆T ≥ 2.2°C). There was a significant between-visit variability in the proportion of plantar ROIs with ∆T ≥ 2.2°C (range 7.6%-30.8%, chi-square test, P = .001). The proportion of patients presenting with hotspots (ROIs with ∆T ≥ 2.2°C), abnormal plantar foot temperature (mean ∆T of 12 plantar ROIs ≥ 2.2°C), and abnormal whole foot temperature (mean ∆T of 33 ROIs ≥ 2.2°C) varied between visits and showed no pattern (P > .05 for all comparisons). This variability was not related to the season of assessment. CONCLUSIONS: Despite the high rate of hotspots on monthly thermograms, all feet remained intact. This study underscores a significant between-visit inconsistency in thermal images of neuropathic feet which should be considered when planning DFU-prevention programs for self-testing and behavior modification.

Effect of Recombinant Human Parathyroid Hormone (1-84) on Resolution of Active Charcot Neuro-osteoarthropathy in Diabetes: A Randomized, Double-Blind, Placebo-Controlled Study.

OBJECTIVE: Fractures in Charcot neuro-osteoarthropathy (CN) often fail to heal despite prolonged immobilization with below-knee casting. The aim of the study was to assess the efficacy of recombinant human parathyroid hormone (PTH) in reducing time to resolution of CN and healing of fractures. RESEARCH DESIGN AND METHODS: People with diabetes and acute (active) Charcot foot were randomized (double-blind) to either full-length PTH (1-84) or placebo therapy, both in addition to below-knee casting and calcium and vitamin D3 supplementation. The primary outcome was resolution of CN, defined as a skin foot temperature difference >2°C at two consecutive monthly visits. RESULTS: Median time to resolution was 5 months (95% CI 4, 12) in intervention and 6 months (95% CI 2, 9) in control. On univariate mixed Cox and logistic regression, there was no significant difference in time to resolution between the groups (P = 0.64) or in the likelihood of resolution (P = 0.66). The hazard ratio of resolution was 0.84 (95% CI 0.41, 1.74; P = 0.64), and the odds ratio of resolution by 12 months was 0.80 (95% CI 0.3, 2.13; P = 0.66) (intervention vs. control). On linear regression analysis, there were no significant differences in the effect of treatment on fracture scores quantitated on MRI scans (coefficient 0.13 [95% CI -0.62, 0.88]; P = 0.73) and on foot and ankle X-rays (coefficient 0.30 [95% CI -0.03, 0.63]; P = 0.07). CONCLUSIONS: This double-blind placebo-controlled trial did not reduce time to resolution or enhance fracture healing of CN. There was no added benefit of daily intervention with PTH (1-84) to below-knee casting in achieving earlier resolution of CN.

Medium-term outcomes of multi-disciplinary surgical management of non-ischemic diabetic heel ulcers.

BACKGROUND: Heel ulcers in patients with peripheral neuropathy and diabetes pose a significant challenge to treating physicians. Infection spreading to the os calcis is associated with a poor prognosis. There is no consensus on which method of surgical treatments results in better outcomes. The aim of this study was to assess patients' survival, rate of ulcer healing following surgical treatment, along with limb salvage rate, time taken for healing, ulcer recurrence and patients' functional outcome after healing. METHODS: We studied 29 patients (20 men, 9 women) presenting with diabetic neuropathic heel ulcers (30 feet) and no critical limb ischemia, were managed surgically in our unit and followed-up for a minimum of 12 months. We assessed their clinical and functional outcomes within a mean follow-up period of 28 months (12-83). RESULTS: 11 out of 29 patients died (38%) with mean duration of post op survival being 31months (range 4-70). 14 ulcers (50%) healed fully within a mean of 360 days (131-1676). Limb salvage was achieved in 29 feet (97%). Only 5 out of 17 patients with diabetic nephropathy (p value 0.016) and 9 out of 24 ulcers with calcaneal osteomyelitis (p value 0.044) achieved full ulcer healing. Ulcer recurrence rate was 36% (5/14) within 12 months of achieving ulcer healing. Six patients were able to return to independent walking in surgical shoes while 11 patients were mobilising using either a crutch or frame. CONCLUSION: While excellent limb salvage can be anticipated from the outcome of surgically managed infected heel ulcers in patients with diabetes, complete healing can still be slow and unpredictable. Significant medical co-morbidities in these patients make them vulnerable to medium-term post-operative complication and survival.

Between visit variability of thermal imaging of feet in people attending podiatric clinics with diabetic neuropathy at high risk of developing foot ulcers.

OBJECTIVE: People with diabetic neuropathy who have previously ulcerated are at high risk of re-ulceration. They should regularly attend podiatry clinics for surveillance and routine protective podiatric treatment. It has been suggested that inflammation prior to skin breakdown shows up as a hotspot on a thermal image even in the absence of clinical signs. The aim of this study is to quantify inter-patient and intra-patient thermal variations presented by diabetic feet at high risk of ulceration. APPROACH: Whole foot and spot temperatures were recorded for 96 patients who attended two successive podiatry appointments without ulceration 28 [28, 31] days apart, median [interquartile range]. This was a part of a longer study into whether thermal imaging in clinic can reduce the rate of re-ulceration. MAIN RESULTS: The variation in spot temperature right/left differences for single patients between visits was comparable to the variation observed between patients (0.8 [0.3, 1.5] °C compared with 0.9 [0.4, 1.7] °C). Similarly, whole foot temperature variation for a single patient between visits was comparable to the variation observed between patients (0.6 [0.2, 1.1] °C compared with 0.8 [0.2, 1.3] °C). SIGNIFICANCE: Thresholds which depend on thermal differences from visit to visit are unlikely to have sufficient specificity to effectively target treatment designed to prevent the development of foot ulcers.

Human epidermal growth factor enhances healing of diabetic foot ulcers.

OBJECTIVE: To study the healing effect of recombinant human epidermal growth factor (hEGF) on diabetic foot ulcers. RESEARCH DESIGN AND METHODS: A total of 127 consecutive patients were screened and 61 diabetic subjects were recruited into this double-blind randomized controlled study. Predetermined criteria were used for diagnosis and classification of the diabetic wound. The patients were randomized into three groups. All patients attended our Diabetes Ambulatory Care Center every other week for joint consultation with the diabetologist and the podiatrist. Group 1 (control) was treated with Actovegin 5% cream (Actovegin), group 2 with Actovegin plus 0.02% (wt/wt) hEGF, and group 3 with Actovegin plus 0.04% (wt/wt) hEGF. The study end point was the complete closure of the wound. Failure to heal was arbitrarily defined as incomplete healing after 12 weeks. RESULTS: Final data were obtained from 61 patients randomly assigned into three groups. The mean ages of the patients, wound sizes, wound duration, metabolic measurements, and comorbidities were comparable within groups, except that group 3 had more female patients. Mean follow-up for the patients was 24 weeks. Data were cutoff at 12 weeks, and results were analyzed by intention to treat. After 12 weeks, in group 1 (control) eight patients had complete healing, two patients underwent toe amputation, and nine had nonhealing ulcers. In group 2 (0.02% [wt/wt] hEGF) 12 patients experienced wound healing, 2 had toe amputations, and 7 had nonhealing ulcers. Some 20 of 21 patients in group 3 (0.04% [wt/wt] hEGF) showed complete wound healing. Healing rates were 42.10, 57.14, and 95% for the control, 0.02% (wt/wt) hEGF, and 0.04% (wt/wt) hEGF groups, respectively. Kaplan-Meier survival analysis suggested that application of cream with 0.04% (wt/wt) hEGF caused more ulcers to heal by 12 weeks and increased the rate of healing compared with the other treatments (log-rank test, P = 0.0003). CONCLUSIONS: Our data support the contention that application of hEGF-containing cream, in addition to good foot care from a multidisciplinary team, significantly enhances diabetic foot ulcer wound healing and reduces the healing time.