IJTRR 2016; 5 (5): International Journal of Therapies & Rehabilitation Research

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1 Original Research Article doi: /ijtrr International Journal of Therapies & Rehabilitation Research E-ISSN EFFICACY OF LOW FREQUENCY ULTRASOUND IN TREATING DIABETIC FOOT ULCER Prof.Dr.Zahra Serry 1, Prof.Dr. Basant El Refaey 1, Lamia Eid 2,* 1 Departement of Cardiovascular/ Respiratory Disorder and Geriatrics, Faculty of Physical Therapy, Cairo University, Cairo, Egypt 2 Departement of Physical Therapy, Omm El-Masryen Hospital, Cairo, Egypt ABSTRACT Background/aim: Diabetes mellitus (DM) is a metabolic disorder resulting from a defect in insulin secretion, insulin action, or both insulin deficiency in turn leads to chronic hyperglycemia with disturbances of carbohydrate, fat and protein metabolism. As the disease progresses tissue or vascular damage ensues leading to severe diabetic complications such as retinopathy, neuropathy, nephropathy, cardiovascular complications and ulceration. The aim of this study was to investigate the effect of low-frequency ultrasound in the treatment of diabetic foot ulcer. Material and methods: Forty male and female with diabetic foot ulcer were chosen from the inpatient department of vascular and general surgery of Omm El-Masriyen hospital to investigate the effect of law frequency ultrasound therapy on diabetic foot ulcer healing, were enrolled in the study. Patients were randomly divided into two equal groups. Group A was the control group and was treated through conservative treatment of wound care with ultraviolet radiation therapy, group B was the study group and was treated through conservative treatment of wound care with ultraviolet radiation therapy and low frequency ultrasound therapy. Results: The results of the present study revealed that low frequency US significantly reduction of ulcers favor to study group and significant differences between both groups at post 15, post 30, post 45 and post 60. The recovery period from ulcers (surface area, ulcer volume) reduced by LFU. Healing of wounds occurred during treatment period was faster in the study group than the control group. Conclusion: We suggest that low frequency ultrasound with 30 khz had a significant effect of promoting the healing rate of ulcers, reduction in the ulcer surface area and ulcer volume for patients with diabetic foot ulcers. KEY WORDS: Diabetes mellitus, Lower frequency ultrasound, Ultraviolet Light. *Lamia Eid Departement of Physical Therapy, Omm El-Masryen Hospital, Cairo, Egypt

2 INTRODUCTION Diabetes mellitus represents a group of chronic diseases characterized by high levels of glucose in the blood resulting from defects in insulin production, insulin action, or both (1). Elevation of blood glucose (hyperglycemia) lead to spillage of glucose into the urine, hence the term sweet urine, the chronic hyperglycemia of diabetes is associated with long-term damage, dysfunction and failure of various organs, especially the eyes, kidneys, nerves, heart and blood vessels (2). Foot ulceration is one of the most common complications in patients with DM the development of diabetic foot ulcer typically results from peripheral neuropathy and vessel disease, but most commonly DFUs typically results from peripheral neuropathy and vessel disease, but most commonly DFUs are caused by peripheral neuropathy complicated by deformity callus, trauma (3). Previous studies have suggested that UVL, combination of UVA, UVB and UVC wavelength triggers cellular actions and physiological effects required for healing chronic wound, by stimulating cell proliferation, increasing epidermal thickening, enhancing blood flow and killing bacteria (4). Therapeutic ultrasound is a highly effective, inexpensive and readily available means of promoting revascularization and healing, " longwave" ultrasound increases penetration depth and, therefore, seems to be more appropriate than traditional high frequency ultrasound (5). METHODS Forty male and female with diabetic foot ulcer were chosen from the inpatient department of vascular and general surgery of Omm El-Masriyen hospital to investigate the effect of low frequency ultrasound therapy on diabetic foot ulcer healing, were enrolled in the study. Age, random blood sugar, duration of diabetes mellitus (DM) and duration of the ulcer values of the patients were recorded. The study was designed as a prospective randomised clinical trial. Patients were randomized into 2 groups, each group consisting of 20 patients. Group A was the control group and was treated through conservative treatment of wound care with ultraviolet radiation therapy, group B was the study group and was treated through conservative treatment of wound care with ultraviolet radiation therapy and low frequency ultrasound therapy. All treatments were applied by the same physiotherapist. Control group (A): This group received the conservative treatment of wound care with ultraviolet c light, It is a lightweight ultraviolet. C device capable of providiving of ease application to the skin (ultraviolet) made in Egypt. It can be supplied with 230V, 50 Hz and 140 watt and wavelength 253nm, the dependant variables ulcer volume and surface are was measured pre, post 15 day, post 30 day, post 45 day and post 60 day. An area of dense yellow surface, necrotic debrise, ulcer base not visible and edges vertical or undermined was treated with the lamp in contact with the ulcer surface and the time of exposure was 150 seconds level. An area of adherent black crust was treated with lamp in contact with the ulcer surface and the time of exposure was 300 seconds. Experimental group (B): This group received the conservative treatment that described in control group plus the low frequency ultrasound therapy which is applied to the intact skin surrounding the wound using coupling gel for contact for 5 minutes 3 times /week for a total treatment period of 8 weeks (24 sessions), and the treatment was delivered at a low frequency of 30 khz, intensity of 50w/cm 2. The low frequency ultrasound head 30 khz was cleaned with alcohol to avoid any infection transmitted to the patient. Ultrasound was applied to the intact skin surrounding the ulcer, the dependant variables ulcer volume and surface are was measured pre, post 15 day, post 30 day, post 45 day and post 60 day. Statistics Statistical analysis was conducted using SPSS for windows, version 18 (SPSS, Inc., Chicago, IL). 2x5 mixed design MANOVA was used to compare the tested variables of interest at different tested groups and measuring periods. With the initial alpha level set at Prior to final analysis, data were screened for normality assumption, homogeneity of variance, and presence of extreme scores. This exploration was done as a pre-requisite for parametric calculations of the analysis of difference. RESULTS No study participant left the research project for any reason. No side effects or complications were observed during the treatment. Baseline characteristics of the patients are shown in Table 1. Control group consisted of twenty ( 6 females, 14 males) with mean age, random blood sugar, duration of diabetes mellitus (DM) and duration of the ulcer values of 52.1±5.85 years, ±32.31,8.15±4.27 years, ±88.71 respectively. Study group consisted of twenty (9 females, 11 males) with mean age, random blood sugar, duration of DM and duration of the ulcer values of 48.7±6.39 years, ±27.19, 4.9±2.90 years, and 88±48.29 respectively. As indicated by the independent t test, there were no significant differences (p>0.05) in the mean values of age, random blood sugar, duration of DM and duration of the ulcer. A. UlcerVolume : 1-Within groups: As presented in table 2, within group's comparison the mean ± SD values of volume ulcer in the "pre", "post 15 ", "post 30 ", "post 45 ", and "post 60 " tests were2.96 ±0.51, 2.45 ±0.52, 1.56 ±0.52, 1.06 ±0.53, and 0.55 ±0.43 respectively in the study group. Multiple pairwise comparison tests (Post hoc tests) revealed that there was significant reduction of ulcer among (pre versus post 15 ), (pre versus post 30 ), (pre versus post 45 ), (pre versus post 60 ), (post 15 versus post 30 ), (post 15 versus post 45 ), (post 15 versus post 60 ), (post 30 versus post 45 ), (post 30 versus post 45 ), (post 30

3 versus post 45 ), and (post 45 versus post 60 ) with (P-value <0.05). As well, the mean ± SD values of ulcer in the "pre", "post 15 ", "post 30 ", "post 45 ", and "post 60 " tests were3.28 ±0.47, 3.09 ±0.57, 2.8 ±0.79,2.52 ±1.06, and 2.3 ±1.28 respectively in the control group. Multiple pairwise comparison tests (Post hoc tests) revealed that there was significant reduction of ulcer volume among (pre versus post 15 ), (pre versus post 30 ), (pre versus post 45 ), (pre versus post 60 ), (post 15 versus post 30 ), (post 15 versus post 45 ), (post 15 versus post 60 ), (post 30 versus post 45 ), (post 30 versus post 45 ), (post 30 versus post 45 ), and (post 45 versus post 60 ) with (Pvalue <0.05) 2- Between groups: Considering the effect of the tested group (first independent variable) on ulcer, Multiple pairwise comparison tests (Post hoc tests) revealed that the mean values of the "pre" test between both groups showed there was no significant differences (P>0.05), while there was significant differences between both groups at post 15, post 30, post 45, and post 60 with (P<0.05). This significant reduction of ulcers favor tthe study group (Table 2). B. Wound surface area: 1- Within groups: As presented in table 3, within group's comparison the mean ± SD values of wound surface area in the "pre", "post 15 ", "post 30 ", "post 45 ", and "post 60 " tests were11.04 ±6.6, 9.12 ±6.07, 7.42 ±5.68, 5.87 ±5.0, and 4.05±4.31 respectively in the study group. Multiple pairwise comparison tests (Post hoc tests) revealed that there was significant reduction of wound surface area among (pre versus post 15 ), (pre versus post 30 ), (pre versus post 45 ), (pre versus post 60 ), (post 15 versus post 30 ), (post 15 versus post 45 ), (post 15 versus post 60 ), (post 30 versus post 45 ), (post 30 versus post 45 ), (post 30 versus post 45 ), and (post 45 versus post 60 ) with (P-value <0.05). As well, the mean ± SD values of wound surface area in the "pre", "post 15 ", "post 30 ", "post 45 ", and "post 60 " tests were14.16 ±4.86, ±5.04, ±5.18, ±5.51, and ±5.88respectively in the control group. Multiple pairwise comparison tests (Post hoc tests) revealed that there was no significant difference of wound surface area among (pre versus post 15 ), (pre versus post 30 ), (pre versus post 45 ), (pre versus post 60 ), (post 15 versus post 30 ), (post 15 versus post 45 ), (post 15 versus post 60 ), (post 30 versus post 45 ), (post 30 versus post 45 ), (post 30 versus post 45 ), and (post 45 versus post 60 ) with (P-value >0.05) 2- Between groups: Considering the effect of the tested group (first independent variable) on wound surface area, Multiple pairwise comparison tests (Post hoc tests) revealed that the mean values of the "pre" test between both groups showed there was no significant differences (P>0.05). while there was significant differences between both groups at post 15, post 30, post 45, and post 60 with (P<0.05). This significant reduction of wound surface area is favor to study group (Table 3). Table 1. Baseline characteristics of the patients. Characteristics Group 1 Group 2 (n = 20) (n = 20) p Age (years) 52.1± ± Random blood sugar mg/dl ± ± Duration of DM (years) 4.15± ± Duration of ulcer () 90± ± Data are presented as mean ± SD or number of patients. Table (2): Descriptive statistics and 2 5 mixed design MANOVA for volume ulcer at different measuring periods at both groups. Multiple pairwise comparison tests (Post hoc tests) for the volume ulcer at both groups Volume Ulcer Pre Post 15 Post 30 Post 45 Post 60 Study group 2.96 ± ± ± ± ±0.43 Control group 3.28 ± ± ± ± ±1.28 Multiple pairwise comparison tests (Post hoc tests) for the volume ulcer within groups at different measuring periods Groups pre Vs. post 15 Pre Vs. post 30 Pre Vs. post 45 Study 0.000* 0.000* 0.000* 0.000* Control 0.009* 0.000* 0.000* 0.000* Pre Vs. post 60 Groups Post15 Post15 Vs. Post15 Post30 Post30 Vs. Post45

4 Vs. post 30 post 45 Vs. post 60 Vs. post 45 post 60 Vs. post 60 Study 0.000* 0.000* 0.000* 0.000* 0.000* 0.000* Control 0.000* 0.000* 0.000* 0.000* 0.000* 0.001* Multiple pairwise comparison tests (Post hoc tests) for the volume ulcer between both groups at different measuring periods P Post 45 Post 15 Post 30 re Post 60 Study group Vs. Control 0 group * 0.000* 0.000* 0.000* *Significant at alpha level <0.05. Table (3):Descriptive statistics and 2 5 mixed design MANOVA for wound surface area at different measuring periods at both groups. Multiple pairwise comparison tests (Post hoc tests) for the wound surface area at both groups Wound surface Pre Post 15 Post 30 Post 45 Post 60 area Study group ± ± ± ± ±4.31 Control group ± ± ± ± ±5.88 Multiple pairwise comparison tests (Post hoc tests) for the different measuring periods wound surface area within groups at Groups pre Vs. post 15 Pre Vs. post 30 Pre Vs. post 45 Pre Vs. post 60 Study 0.000* 0.000* 0.000* 0.000* Control Groups Post15 Vs. post 30 Post15 Vs. post 45 Post 15 Vs. post 60 Post 30 Vs. post 45 Post 30 Vs. post 60 Post 45 Vs. post 60 Study 0.000* 0.000* 0.000* 0.000* 0.000* 0.000* Control Multiple pairwise comparison tests (Post hoc tests) for the wound surface area between both groups at different measuring periods Pre Post 15 Post 30 Post 45 Post 60 Study group Vs. Control group * 0.002* 0.000* 0.000* *Significant at alpha level <0.05. DISCUSSION 4. Discussion The results of the present study revealed that low frequency ultrasound (LFU) significantly reduced ulcer volume and surface area of ulcers favoring the study group and significant differences between both groups at post 15, post 30, post 45 and post 60. The recovery period from ulcers (surface area, ulcer volume) reduced by LFU. Healing of wounds occurred during treatment period was faster in the study group than the control group. Low frequency ultrasound waves lead to more than 50 % decrease in wound size and accelerate the healing rate of chronic diabetic foot ulcers even in chronic sever ischemic wounds and act this through 2 mechanisms : micro cavitation and acoustic streaming. Microcavitation lead to cell changes and destruction of tissue adjacent to the ultrasound wave, and will also cause a rapid lysis of the necrotic tissue and fibrosis from the ulcer. Acoustic streaming increases cell permeability which in turn causes an increase in synthesis and production molecules such as collagen growth factors, and nitrate oxide synthesis. These molecules all take part in accelerating the wound healing process (6). Beside the stimulatory effect of LFU waves on fibroblasts as demonstrated in studies of wound healing, therapeutic LFU has been reported to stimulate the secretion of mitogenic factors from macrophages, which are important cells in the immune response to chronic inflammation. The observation that macrophages can be stimulated by ultrasound could support the clinical studies that suggested an optimal use for LFU during chronic inflammation rather than during acute inflammation (7).

5 The effect of stable cavitation and acoustic streaming appear to increase calcium ion diffusion across the cell membrane, this in turn causes mast cell degranulation with release of histamine and other factors. In this way LFU therapy has the potential to accelerate normal resolution of inflammation providing that the inflammatory stimulus is removed. This acceleration could also be due to the gentle agitation of the tissue fluid, which may increase the rate of phagocytosis (8). The positive effects of LFU in this study confirm the findings of (Sen et al.,2009) (9) who studied the effect of 30khz low dose ultrasound in the local treatment of chronic diabetic foot ulcers. Twenty four patients were randomized to conventional therapy with topical application of hydrocolloid dressings and compression therapy with additional ultrasound treatment for 12 weeks. After 12 weeks the control group showed a mean decrease in the ulcer surface area 16.5% whereas in the ultrasound treated group the mean ulcerated area decreased by 55.4%. They concluded that the application of low frequency and low dose ultrasound is a helpful treatment option in chronic diabetic foot ulcer especially if they do not respond to conventional ulcer treatment. Also ( Kavros et al., 2007)(10) reported that LFU waves have an effective role in the treatment of chronic wounds, observed that the rate and speed of complete healing in a group receiving LFU treatment in combination with standard wound care was significantly higher than the control group that received only standard wound care, which supports current study results. Similarly a small randomized controlled trial involving 24 patients with chronic leg ulceration showed that all the patients responded to the treatment of low frequency ultrasound (30khz) and low dose ultrasound which concided with the present results (11). Several case studies demonstrated that the low frequency ultrasound was a useful tool in the management of chronic wounds not only for healing but also for pain, pigmentation and odour reduction (12). The variability between the results obtained by the current study and other reviewed studies is likely because of differences in session duration, total treatment time and duration between different sessions. The ultraviolet C radiation at 254nm. is a promising adjunctive therapy for chronic wounds, can kill antibiotic-resistant strains of bacteria such as methicillin-resistant, staphylococcus, aureus. Ultraviolet is absorbed directly by extracellular fluid components and epithelial cell that proliferate in superficial wounds (13). The positive effects of UVC in this study confirm the findings of ( Dai et al., 2012)(14). Who appears to be that UVC has a systemic effect, they found clinically reduced hypertrophic healing and bactericidal effect in treated and untreated wounds. UVC is specifically used for rapid wound debridement due to effect on surface slough and its effect against ongoing bacterial contamination and infection, so UV is ideal for these areas. In contrast to current study findings, some studies reported that there was no advantage in using UVC treatment and concluded the factors that prevent transmission of UV rays are skin thickening and pigmentation it may also because of difference in session duration and total treatment time (15). In conclusion, the results of the current study showed low frequency ultrasound with 30khz had a significant effect of promoting the healing rate of ulcers, reduction in the ulcer surface area and ulcer volume for patients with diabetic foot ulcers. Declaration of interest: The authors report no conflict of interest. The authors alone are responsible for the REFERENCES 1. American Diabetes Association (2010): Diagnosis and classification of diabetes mellitus. Diabetes care;37 (Suppl 1) American Diabetes association (2011): Summary of revians to the 2011 clinical practice recommendations. Diabetes care 34:53; Doi Duckworth W, Abraira C, Miritz T, et al (2009): VADT investigators. Glucose control and vascular complications in veterans with type 2 diabetes. N EnglMed. ;360: Haughton PE, Campbell KF. (2001): Therapeutic modalities n the treatment of chronic redcolictrant wands. In krosner DL, Rod eheaver GT, Sibblad RG (eds). Chronic wands care :AclinicalSwce Book for health care professionals, Third Edition. Wayne, Pa: HMP communications; Jeferry Voigt, MBA, MPH, MattinWendelken, DDP Rnmvike Driver, MS, DPM, Oscar M. Alvorez, PhD. 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