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Revista de medicina y complicaciones diabéticas

Volumen 2, Asunto 1 (2017)

Artículo de investigación

A Randomized, Sham-Controlled, Double-Blind Pilot Study of Pulsed Electromagnetic Field Therapy to Evaluate Small Fiber Nerve Growth and Function and Skin Perfusion in Subjects with Painful Peripheral Diabetic Neuropathy

Tallis AJ, Jacoby R, Muhlenfeld J and Smith APS

Purpose: The objective of this study was to determine the potential efficacy and safety of dual energy pulsed electromagnetic field therapy (PEMF) on painful distal symmetric diabetic sensorimotor polyneuropathy (DSPN).

Methodology: Subjects with Type 2 diabetes and painful DSPN were randomized to receive either an active or sham PEMF device. Objective measures of efficacy (skin biopsy, nerve conduction velocity (NCV) studies, dorsal and plantar foot skin perfusion pressure (SPP) were performed prior to and following 60-days of twice daily 30 minute treatments. Patient reported outcomes included perception of pain, concomitant medication use and adverse events.

Major findings: Dorsal foot SPP improved with PEMF (n=11), change from baseline=19.6 mmHg) vs. sham (n=7, change=-17.4 mmHg), p=0.03. Trends in favor of PEMF vs sham were observed for medial nerve (n=4), planter nerve (n=4) and sural nerve (n=15) onset time and amplitude (p>0.05) other than medial planter onset time (p=0.04). Although change in pain scores were similar, compliance with device use was higher in the active group compared to the sham control. The series of tests and long-term use of PEMF was well-tolerated and feasible. No device related adverse effects were recorded.

Principal conclusions: Twice daily PEMF therapy was feasible, well-tolerated, and associated with trends suggesting improved nerve function and microcirculation in patients with painful DSPN. Future, large randomized controlled trials are necessary to confirm these findings and evaluate the potential longer term benefits on symptoms and pathology of DSPN.

Artículo de investigación

The Possibility of using Serum Taurine Level as an Early Marker to Control Complications of Diabetic Foot

Agouza IME, Taha A, Mahfouz AA, Shalash NM and Taha KH

Objective: Measuring of serum taurine as an early marker to detect and prevent complications of Diabetic foot.

Methods: 90 diabetic patients were selected from the national institute of diabetes and endocrinology (NIDE), 80 patients suffered from diabetic foot and classified into 4 groups according to its surgical complication in their foot and 10 diabetic controlled patients not suffered from diabetic foot considered as diabetic control group. 10 frank healthy non diabetic persons enrolled as volunteers. Complete clinical examination, investigation and biochemical analysis (liver and kidney functions, lipid profile and complete blood count), add to measuring FBG, HbA1c, VEGF and the recent biomarker taurine, was measured for all patient and volunteers.

Results: The data showed non-significant change in liver functions, Kidney functions, lipid profile, CBC and serum VEGF in all patients regarding to control group (P>0.05). Contrary there is a significance changes in FBG and HbA1c (P<0.05). On the other hand, the data showed very highly significant decrease in serum taurine in all diabetic patients according to the severity of diabetic foot compared to that recorded in healthy control (P<0.001).

Conclusion: Serum taurine is reduced in diabetic patients with advanced surgical conditions of diabetic foot. Taurine Level is considered as an early marker (prognostic) to control complications of diabetic foot.

Artículo de investigación

A Pilot Study to Evaluate the Efficacy of IZN 6D4 for the Treatment of Diabetic Foot Ulcers

Menachem Oberbaum and Jonathan Rosenblum

Diabetic foot ulcers (DFU), which can affect up to 15% of individuals with diabetes, remain a major unmet medical need. Left untreated, DFU seriously impact on quality of life and level of function. Conventional treatment is costly and often ineffective. In severe cases, patients with DFU may undergo painful amputations. IZN 6D4 is an impregnated hydrogel containing active pharmaceutical ingredients that have both wound-healing promoting and anti-inflammatory activities This is an observational human clinical trial study involving 15 patients treated with IZN 6D4. Subjects in the study had DFU which were categorized as being at stage 1A or greater using the University of Texas Health Science Center, San Antonio scale (UTHSC) grading system. Treatment lasted 21 days, and during the course of the study, patches were applied every 3-4 days. Response to therapy was measured by extent and depth of the lesion (wound grid and digital photography), qualitative assessment of wound healing (tissue granulation), and the rate of wound closure over the trial period. Results of the study showed that 40% of subjects had 75% closure of the wound and 27% had complete wound closure. Nearly all patients had evidence of active wound healing (e.g., presence of granulation tissue), and percent mean wound reduction for the entire study group was 67.7 ± 26.4%. Photo documentation of wound healing showed impressive differences between pre- and posttreatment appearances of diabetic ulcers in many of the patients studied. Based on the promising data from preclinical studies and the observational clinical trial provide strong justification for initiating a large-scale, longer duration clinical trial evaluating the efficacy of IZN 6D4 hydrogel in the treatment of patients with DFU.

Artículo de investigación

Serum Selenium Concentration and Subsequent Risk of Diabetes Miletus in Pakistan

Amna Alam, Asad Ali, Arif Lodhi, Sadia Alam, Naseem Rauf, Muhammad Ateeq and Peter Langer

Background: The purpose of the study was to explore a relationship between serum Selenium level and diabetes.
Methods: Analysis of 100 blood samples were carried out, collected from Institute of Medical Sciences (PIMS), Islamabad, Pakistan. All the subjects selected were local inhabitants of Rawalpindi and Islamabad and their serum selenium levels were measured by hydride generation atomic absorption spectrometer.
Results: Analysis of the mean serum selenium level in the male and female patients of both type I and II were 169 ± 91 μg/L and 199.25 ± 120 μg/L respectively while mean serum selenium level among males and females of healthy subjects was 245.59 ± 131 μg/L and 239.92 ± 138.
Conclusion: Serum Selenium level and Diabetes has an inverse relation.

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