Comparison of a Bioimplant Dressing With a Wet Dressing for the Treatment of Diabetic Foot Ulcers: A Randomized, Controlled Clinical Trial.

BACKGROUND: The authors aimed to evaluate the efficacy of a bioimplant dressing in comparison with a wet dressing in patients with diabetic foot ulcers (DFUs). MATERIALS AND METHODS: Fifty-seven patients with diabetes who had an ulcer of Wagner Grades 2-4 were included in this controlled clinical trial. The study was conducted in the outpatient diabetic foot clinic of Dr. Shariati Hospital, affiliated with the Endocrinology and Metabolism Research Institute, Tehran University of Medical Sciences, Tehran, Iran, from November 2010 to March 2012. Fifty-seven cases of DFUs were equally and randomly divided into control and test groups. The bioimplant group received an amniotic membrane dressing while the control group was treated with a wet dressing. Both groups were evaluated once a week for 6 weeks for the degree of epithelialization and granulation tissue of the wound. RESULTS: The complete healing rate (ie, wound closure) in the whole study population was 28.1% (control group, 16.7%; bioimplant group, 40.7%, P = 0.04). In 21 patients (77.77%) of the bioimplant group, granulation tissue was extended within the third visit. Amputation and hospitalization rates were higher in the control group compared to the bioimplant group; however, the difference was not statistically significant (relative risk [RR]: 1.11, 95% CI 0.91-1.34, P = 0.258; RR: 1.27, 95% CI 0.97-1.66, P = 0.076, respectively). CONCLUSION: The bioimplant dressing was significantly superior to the wet dressing in prompting the complete healing of DFUs. Ease of use, absence of adverse effects, and a facilitated wound healing process are among properties of amniotic membrane that make it an appropriate dressing in the management of DFUs. Additional research will shed more light on the promising advantages of this material in healing DFUs.

Effect of low-intensity direct current on expression of vascular endothelial growth factor and nitric oxide in diabetic foot ulcers.

This study investigated the effect of low-intensity cathodal direct current on the release of plasma vascular endothelial growth factor (VEGF) and nitric oxide (NO) in diabetic foot ulceration. Twenty type 2 diabetic patients with foot ulceration and thirteen age-matched healthy subjects were enrolled. Patients were randomly assigned to electrical stimulation (ES) (n = 10) or sham ES (placebo, n = 10) groups. The ES group received cathodal direct current (1.48 +/­ 0.98 mA) for 1 h/d,3 d/wk for 4 wk (12 sessions). Blood samples were collected for VEGF and NO measurement in the first and last treatment sessions before and after intervention. Wound surface area and skin temperature were measured at the 1st, 6th, and 12th sessions. VEGF significantly increased in the ES group compared with the placebo group after the 1st (106.61 +/­ 79.50 and 40.88 +/­ 26.20, respectively) and 12th sessions (109.28 +/­ 67.30 and 34.79 +/­ 13.20, respectively). NO level also increased significantly in the ES group compared with the placebo group after the 12th session (44.21 +/­ 14.00 and 35.25 +/­11.00, respectively). The increase of skin temperature was significantly higher in the ES group than the placebo group. Application of low-intensity ES increases the expression of VEGF and NO, which may lead to improved blood flow and tissue temperature and, consequently, wound healing in diabetic foot ulceration.

Low-frequency ultrasound debridement in patients with diabetic foot ulcers and osteomyelitis.

BACKGROUND: Although debridement plays a significant role in the healing of diabetic foot ulcers, it may delay the healing process by damaging the granulation tissue. In this study, the efficacy of low-frequency ultrasound (LFU) in chronic wound healing in diabetic foot ulcers in patients with osteomyelitis was evaluated. METHODS: This randomized clinical trial was conducted on 40 patients with diabetes recruited from the Diabetic Foot Ulcer Clinic of the Endocrinology and Metabolism Research Center of Tehran University of Medical Sciences, Tehran, Iran. All patients with a grade 3 ulcer (Wagner Classification) with 0.6 ≤ ankle brachial index ≤ 1.2, were included. Patients were divided into 2 groups; 1 group received ultrasound-assisted wound therapy (UAW) in conjunction with standard wound care (n = 20) and the control group received only standard wound care. Patients were followed for 6 months. RESULTS: The complete healing rate in the study population was 55.7% (control group = 55%, UAW group = 60%). The mean wound size reduction percentage was significantly higher in the UAW group only in the second month (78% ± 28.7 vs 55.7% ± 31.4, P = 0.01) and third month (63.6% ± 24.5 vs 39.3% ± 32.2 , P = 0.02) of follow up, but not at 6 months. CONCLUSION: In grade 3 diabetic foot ulcers, LFU debridement accompanied by standard wound care can initially accelerate ulcer healing; however, there is no significant difference between the 2 modalities in the healing rate after 6 months. .

Traumatic brain injury and adrenal insufficiency: morning cortisol and cosyntropin stimulation tests.

INTRODUCTION: Adrenal insufficiency (AI) has a great impact on the prognosis of patients with traumatic brain injury. There is a lack of consensus regarding the diagnostic criteria of AI. In these patients with acute stress we compared fasting cortisol, low and high dose cosyntropin stimulation tests to assess adrenal function in patients with moderate to severe traumatic brain injury. MATERIAL AND METHODS: This multicenter, cross-sectional study recruited 50 consecutive patients (aged between 15 and 70 years old) with moderate to severe traumatic brain injury who survived more than 5 days after the event. The patients' adrenal function was assessed using the fasting cortisol, 1 and 250-µg ACTH stimulation tests. RESULTS: More cases of AI were detected by the 1-µg ACTH stimulation test compared to those detected by the basal serum cortisol level and 250-µg ACTH stimulation test. The κ test showed no agreement between these tests. The incidence of AI in the first 10 days after traumatic brain injury varied from 34% to 82% according to the various definitions of AI. The incidence of hypotension and need for vasopressors was higher in the patients diagnosed by the 250-µg ACTH stimulation test (p < 0.0001). CONCLUSIONS: The incidence of secondary AI in moderate to severe traumatic brain injury seems to be high. A combination of stimulation test (either 250 or 1 µg) and basal cortisol level may improve diagnostic ability compared to either test alone. Hence performing both tests for the assessment of adrenal function in patients with traumatic brain injury is recommended.

Major adverse events, six months after endovascular revascularization for critical limb ischemia in diabetic patients.

BACKGROUND: This prospective study aimed to evaluate the detailed outcomes of diabetic patients with critical limb ischemia, six months after percutaneous transluminal angioplasty and appropriate multidisciplinary wound care.  METHODS: Totally, 45 consecutive patients (50 limbs) were enrolled and then divided into two groups according to the healing of ulcers. The endpoints were ulcer healing and major adverse events including amputation, mortality, and cardiac or cerebral morbidities, during a six- month follow-up period.  RESULTS: During six months follow-up, major amputation was performed for four of 50 limbs (8.0%). A total of nine (20%) patients died and the leading cause was cardiac death (13.3 %). Also, stroke and non-fatal myocardial infarction occurred in three (6.7 %) and one (2.2 %) of the patients, respectively. Among the 29 (59.2 %) healed wounds, 22 (44.9 %) were completely closed. The patients with nonhealing wounds had a higher rate of dialysis (40% vs. 0 %, P-value < 0.001) and more ulcers with stage of D3 according to the Texas Wound Classification (60% vs. 31 %, P-value = 0.016). Other demographic, clinical, ulcer characteristics and procedural characteristics such as number and level of the treated lesions did not differ significantly between the two groups.  CONCLUSION: Based on our findings, it seems that along with current usual therapeutic routines which focus on wound healing and limb salvage, more attention should be paid to simultaneous diagnostic assessments and treatment of cardiovascular disease in this group of patients during short-term follow- up.

The effect of inhaled corticosteroids on hypothalamic-pituitary-adrenal axis.

OBJECTIVES: The aim of this study was to compare systemic effects of high-dose fluticasone propionate (FP) and beclomethasone dipropionate (BDP) via pressurized metered dose inhaler on adrenal and pulmonary function tests. MATERIALS AND METHODS: A total of 66 patients with newly diagnosed moderate persistent asthma without previous use of asthma medications participated in this single blind, randomized, parallel design study. FP or BDP increased to 1 500 µg/d in 62 patients who had not received oral or IV corticosteroids in the previous six months. Possible effects of BDP and FP on adrenal function were evaluated by free cortisol level at baseline and after Synacthen test (250 µg). Fasting plasma glucose and pulmonary function tests were also assessed. Similar tests were repeated 3 weeks after increasing dose of inhaled corticosteroids to 1 500 µg/d. RESULTS: No statistically significant suppression was found in geometric means of cortisol level post treatment in both groups. After treatment in FP group, mean forced expiratory volume in one second (FEV1) and mean forced vital capacity (FVC) values improved by 0.17 l (5.66% ± 13.91, P=0.031) and 0.18 l (5.09% ± 10.29, P=0.010), respectively. Although FEV1 and FVC improved in BDP group but was not statistically significant. Oral candidiasis and hoarseness were observed in 6.5% patients receiving BDP, but hoarseness was found in 3.2% patients in FP group (P=0.288). CONCLUSIONS: The results indicate that safety profiles of high doses of BDP and FP with respect to adrenal function are similar, but FP is more efficacious than that of BDP in improving pulmonary function test.