Search Results
The Diabetic Person Beyond a Foot Ulcer
Healing, Recurrence, and Depressive Symptoms
Background: Several studies have shown a significant relationship between depressive symptoms and wound healing, but these studies have not assessed the effects of depressive symptoms on diabetic foot prognosis. We specifically designed our study to assess the role of depressive symptoms in healing and recurrence of diabetic foot ulcers.
Methods: A consecutive series of 80 type 2 diabetic patients aged 60 years and older with foot ulcers was enrolled in a cohort observational study with a 6-month follow-up. Patients who healed within 6 months of enrollment were included in a 12-month follow-up study for assessment of ulcer recurrence. Depressive symptoms were assessed with the geriatric depression scale.
Results: Healing was associated with a smaller ulcer area, shorter delay between ulcer onset and treatment, lower glycosylated hemoglobin, and higher ankle-brachial index. Both smoking status and Texas and Wagner scores also had a significant impact on healing. Patients who healed had significantly lower scores on the geriatric depression scale, and those with scores = 10 had a significantly higher risk of not healing at 6 months (relative risk, 3.57; 95% confidence interval, 1.05–12.2). Patients with a recurrent ulcer (59.3%) showed significantly higher total cholesterol levels, higher scores on the Greenfield index of disease severity and geriatric depression scale, and a higher prevalence of cerebrovascular disease. Depressive symptoms maintained a significant association with persistence and recurrence of ulcer even after adjustment for confounders.
Conclusions: Depressive symptoms are associated with impaired healing and recurrence of ulcers in elderly type 2 diabetic patients. (J Am Podiatr Med Assoc 98(2): 130–136, 2008)
A Diabetic Foot Ulcer Pilot Study
Does Silicone Gel Sheeting Reduce the Incidence of Reulceration?
Background: Silicone gel sheeting is an effective therapeutic intervention in the management of scar tissue. This pilot study was designed to examine the effect of silicone gel sheeting in preventing reulceration at former wound sites in diabetic patients.
Methods: Thirty patients with diabetes and a healed plantar neuropathic foot ulcer were enrolled and investigated in this randomized controlled trial. Participants with a newly healed ulcer were assigned to use either silicone gel sheeting or emollient cream daily for 3 months.
Results: Compared with emollient cream use, the use of silicone gel sheeting did not diminish and may have potentially increased the risk of reulceration.
Conclusions: Silicone gel sheeting does not seem to reduce the risk of reulceration in diabetic patients. The results of this trial should be viewed with caution given the small sample size. (J Am Podiatr Med Assoc 101(2): 116–123, 2011)
A prospective, randomized study was conducted to determine the effect of biofeedback-assisted relaxation training on foot ulcer healing. For patients with chronic nonhealing foot ulcers, medical care was combined with a standardized biofeedback-assisted relaxation training program in the experimental group. The intervention was designed to increase peripheral perfusion, thereby promoting healing. A total of 32 patients with chronic nonhealing ulcers participated in the study. In the experimental group, 14 out of 16 ulcers (87.5%) healed, as compared with 7 out of 16 ulcers (43.8%) in the control group. (J Am Podiatr Med Assoc 91(3): 132-141, 2001)
Background: This study reevaluates the previously reported subjective benefits of surgical nerve decompression in diabetes with an easily observable, fully objective outcome measure to eliminate the placebo effect and observer bias.
Methods: A retrospective review was conducted of a series of 75 feet in 65 patients with diabetes and previous neuropathic ulcer who had surgical decompressions of the peroneal and posterior tibial nerve branches at anatomical fibro-osseous tunnels. After a minimum of 12 months of follow-up, the incidence of ipsilateral ulcer was assessed.
Results: Postoperatively, four ulcer recurrences and four new-site ulcers developed in 187 patient-years. Mean follow-up was 2.49 years (range, 1–13 years). The combined linear annual risk of ipsilateral recurrence and new ulcer is 4.28%, the lowest reported in the scientific literature.
Conclusions: Surgical decompression of lower-extremity nerves of high-risk feet at fibro-osseous anatomical tunnels was followed by a low annual incidence of ulcer recurrence. This objective outcome measure suggests benefits of nerve decompression in diabetic neuropathy, as have previous reports using pain and sensory change as subjective measures. Unrecognized nerve entrapment may frequently coexist with diabetic sensorimotor peripheral neuropathy in patients with diabetic foot ulcer. (J Am Podiatr Med Assoc 100(2): 111–115, 2010)
Background
Diabetic foot ulcer (DFU) is well managed by infection control, euglycemic state, and debridement of the ulcer followed by appropriate dressing and off-loading of the foot. Studies show that approximately 90% of DFUs that are properly off-loaded heal in nearly 6 weeks. Platelet-rich plasma (PRP) serves as a growth factor agonist and has mitogenic and chemotactic properties that help in DFU healing. We sought to evaluate the efficacy of local application of PRP with respect to healing rate and ulcer area reduction in treating DFUs.
Methods
Sixty noninfected patients with DFUs (plantar surface area, ≤20 cm2; Meggitt-Wagner grades 1 and 2) were randomized to receive normal saline dressing (control group [CG]) or PRP dressing (study group [SG]) along with total-contact casting for 6 weeks or until complete ulcer healing, whichever was earlier. Healing rate and change in ulcer area were evaluated weekly.
Results
Mean ± SD ulcer area at baseline was 4.96 ± 2.89 cm2 (CG) and 5.22 ± 3.82 cm2 (SG) (P = .77), decreasing to 1.15 ± 1.35 cm2 (CG) and 0.96 ± 1.53 cm2 (SG) (P = .432) at 6 weeks. Mean ± SD percentage reduction in healing area at 6 weeks was 81.72% ± 17.2% (CG) and 85.98% ± 13.42% (SG) (P = .29). Mean ± SD healing rate at 6 weeks was 0.64 ± 0.36 cm2 (CG) and 0.71 ± 0.46 cm2 (SG) (P = .734).
Conclusions
The PRP dressing is no more efficacious than normal saline dressing in the management of DFU in conjunction with total-contact casting.
Background
It is well known that interleukin-18 (IL-18) plays a key role in the inflammatory process. However, there are limited data on the role IL-18 plays with diabetic foot ulcers, an acute and complex inflammatory situation. Therefore, we aimed to evaluate serum IL-18 levels of diabetic patients with foot ulcers.
Methods
Twenty diabetic patients with acute foot ulcers, 21 diabetic patients without a history of foot ulcers, and 21 healthy volunteers were enrolled in our study. Circulating levels of IL-18, and other biochemical markers are parameters of inflammation and were measured in all three groups.
Results
Diabetic patients both with and without foot ulcers had high IL-18 concentrations (P < 0.001 and P = 0.020, respectively) when compared with the nondiabetic volunteers. Those with foot ulcers had higher levels of IL-18 level (P < 0.001), high-sensitivity C-reactive protein (hsCRP) (P = 0.001), and erythrocyte sedimentation rate (ESR) (P < 0.001) than those without foot ulcers.
Conclusions
We found that serum IL-18 concentrations were elevated in diabetic patients with acute diabetic foot ulcers. However, these findings do not indicate whether the IL-18 elevation is a cause or a result of the diabetic foot ulceration. Further studies are needed to show the role of IL-18 in the course of these ulcers.
Background: We assessed the tolerability and efficacy of autologous skin cell grafts in older type 2 diabetic patients with chronic foot ulcers.
Methods: Treatment with Hyalograft 3D and Laserskin Autograft was proposed to a consecutive series of type 2 diabetic patients older than 65 years affected by long-standing (>6 months) foot ulcers with an area greater than 15 cm2. Ulcer healing rates and measurements of ulcer area were determined monthly for 12 months.
Results: Seven patients with 12 ulcers, nine of which received the described treatment, were enrolled. During 12-month follow-up, all of the ulcers healed except one. In the remaining eight ulcers, the median healing time was 21 weeks (interquartile range, 4–29 weeks).
Conclusions: Autologous skin cell grafts are feasible, well tolerated, and apparently effective in the treatment of diabetic ulcers of the lower limbs in advanced age. Age did not seem to moderate healing times. (J Am Podiatr Med Assoc 101(1): 55–58, 2011)
The Management of Diabetic Foot Ulcers Through Optimal Off-Loading
Building Consensus Guidelines and Practical Recommendations to Improve Outcomes
Background
We sought to develop a consensus statement for the use of off-loading in the management of diabetic foot ulcers (DFUs).
Methods
A literature search of PubMed for evidence regarding off-loading of DFUs was initially conducted, followed by a meeting of authors on March 15, 2013, in Philadelphia, Pennsylvania, to draft consensus statements and recommendations using the GRADE (Grading of Recommendations Assessment, Development, and Evaluation) approach to assess quality of evidence and develop strength of recommendations for each consensus statement.
Results
Evidence is clear that adequate off-loading increases the likelihood of DFU healing and that increased clinician use of effective off-loading is necessary. Recommendations are included to guide clinicians on the optimal use of off-loading based on an initial comprehensive patient/wound assessment and the necessity to improve patient adherence with off-loading devices.
Conclusions
The likelihood of DFU healing is increased with off-loading adherence, and, current evidence favors the use of nonremovable casts or fixed ankle walking braces as optimum off-loading modalities. There currently exists a gap between what the evidence supports regarding the efficacy of DFU off-loading and what is performed in clinical practice despite expert consensus on the standard of care.
Cost-Effectiveness of Becaplermin Gel on Diabetic Foot Ulcer Healing
Changes in Wound Surface Area
Background: A comparison of the cost-effectiveness of becaplermin plus good wound care (BGWC) versus good wound care (GWC) alone in treating patients with diabetic foot ulcers (DFUs) may enable physicians and health-care decision makers in the United States to make better-informed choices about treating DFUs, which currently contribute to a substantial portion of the economic burden of diabetes.
Methods: Data from three phase III trials were used to predict expected 1-year costs and outcomes, including the average percentage reduction from baseline in wound surface area (WSA), the direct costs of DFU therapy, and the cost per cm2 of WSA reduction.
Results: At 20 weeks, the BGWC group had a statistically greater probability of complete wound closure than the GWC group (50% versus 35%; P = .015). Based on reported WSA reduction rates, DFUs in the BGWC group were predicted to close by 100% at 27 weeks, and those in the GWC group were predicted to close by 88% at 52 weeks. The GWC group had higher total estimated 1-year direct cost of DFU care ($6,809 versus $4,414) and higher cost per cm2 of wound closure ($3,501 versus $2,006).
Conclusions: Becaplermin plus good wound care demonstrated economic dominance compared with GWC by providing better clinical outcomes via faster reduction in WSA and higher rates of closure at a lower direct cost.
Quality of Life in People with Their First Diabetic Foot Ulcer
A Prospective Cohort Study
Background: People with diabetic foot ulcers report poor quality of life. However, prospective studies that chart quality of life from the onset of diabetic foot ulcers are lacking. We describe change in quality of life in a cohort of people with diabetes and their first foot ulcer during 18 months and its association with adverse outcomes.
Methods: In this prospective cohort study of adults with their first diabetic foot ulcer, the main outcome was change in Medical Outcomes Study 36-Item Short Form Health Survey scores between baseline and 18-month follow-up. We recorded baseline demographics, diabetes characteristics, depression, and diabetic foot outcomes and mortality at 18 months.
Results: In 253 people with diabetes and their first ulcer, there were 40 deaths (15.8%), 36 amputations (15.5%), 99 recurrences (43.2%), and 52 nonhealing ulcers (21.9%). The 36-Item Short Form Health Survey response rate of survivors at 18 months was 78% (n = 157). There was a 5- to 6-point deterioration in mental component summary scores in people who did not heal (adjusted mean difference, −6.54; 95% confidence interval, −12.64 to −0.44) or had recurrent ulcers (adjusted mean difference, −5.30; 95% confidence interval, −9.87 to −0.73) and a nonsignificant reduction in those amputated (adjusted mean difference, −5.00; 95% confidence interval, −11.15 to 1.14).
Conclusions: Quality of life deteriorates in people with diabetes whose first foot ulcer recurs or does not heal within 18 months. (J Am Podiatr Med Assoc 99(5): 406–414, 2009)
