Article 227
Treatment of Diabetic Foot Ulcers using Mepilex Lite Dressings: A Pilot Study
Affiliations
Key words ▶ foot ulcers ● ▶ diabetes mellitus ● ▶ Mepilex Lite dressing ● ▶ wound healing ● ▶ nursing ●
received 12.12.2013 first decision 29.01.2014 accepted 05.02.2014 Bibliography DOI http://dx.doi.org/ 10.1055/s-0034-1370918 Published online: March 12, 2014 Exp Clin Endocrinol Diabetes 2014; 122: 227–230 © J. A. Barth Verlag in Georg Thieme Verlag KG Stuttgart · New York ISSN 0947-7349 Correspondence Y. Zhang Department of Nutrition School of Clinical Medicine Binzhou Medical College No.661 Yellow-River Second Street Binzhou 256603 China Tel.: + 86/0543/3258 870 Fax: + 86/0543/3258 870 [email protected]
Y. Zhang1, S.-Z. Xing2 1 2
Department of Nutrition, School of Clinical Medicine, Binzhou Medical College, Binzhou, China Department of Oncology, School of Clinical Medicine, Binzhou Medical College, Binzhou, China
Abstract
▼
Background: 5–10 % diabetes patients will develop diabetic foot ulceration at some time during the life. The purpose of this study was to compare the effectiveness of Mepilex Lite dressings and vaseline gauze care in the healing of foot ulcers in diabetic patients. Methods: This was a randomized controlled trial, and a sample of 50 diabetic patients who had developed foot ulcers was assessed. Comparisons were made regarding parameters related to wound healing, including healing time and wound pain, and also regarding the adverse events.
Introduction
▼
Diabetic foot ulceration is estimated to occur in 5–10 % of the population with diabetes, and is one of the most common complications of diabetes mellitus [1]. It is not only a typical complication in later stages of diabetes but also occur in patients with newly diagnosed disease [2]. Foot complications in people with diabetes can be difficult to treat and conventional therapies often fail, leading to lower limb amputations [3]. Thus, prevention of this condition is of paramount importance. The current standard treatment for diabetic foot ulcers consists of debridement, control of infection, pressure relief, and lower extremity revascularization when required [4]. Dressings are widely used in wound care, with the aim of protecting and managing the wound and promoting healing. Guidelines for the treatment of diabetic foot ulcers maintain that clinical judgement should be used to select a moist wound dressing [5]. Several dressing types are available to treat complex wounds including diabetic foot ulcers.
Results: The results showed that foot ulcers in the study group (Mepilex Lite, 24 patients) healed in a median of 49.9 days, which was significantly different from the healing time in the control group (median, 65.5 days, 26 patients; P = 0.038). No statistically significant differences were detected between the 2 groups with pain. However, Mepilex Lite dressings significantly reduced wound area (P < 0.05). Conclusions: The researchers conclude that Mepilex Lite dressing provides a promising alternative to diabetic foot ulcers and is worthy of further research.
Mepilex® Lite (Mölnlycke Health Care, Gothenburg, Sweden) is one of a number of dressings that created by combining Safetac® soft silicone technology to ensure that they adhere to intact dry skin but not to moist wound beds [6]. Mepilex Lite could be used on a wide range of acute wounds (e. g. skin tears, abrasions and second degree burns), chronic wounds, skin disorders (e. g. epidermolysis bullosa), as well as for the fixation of grafts. It can be left in place for up to 14 days, with the secondary dressing changed as frequently as required, so avoiding disturbance of the wound bed [7]. The purpose of this investigation was to determine the efficacy of Mepilex Lite dressings on healing in diabetic foot ulcers by conducting a randomized, controlled trial analyzed on an intention-to-treat basis. The primary endpoint was complete (100 %) wound closure. Pain and the occurrence of adverse events were also considered.
Zhang Y, Xing S-Z. Treatment of Diabetic Foot … Exp Clin Endocrinol Diabetes 2014; 122: 227–230
This document was downloaded for personal use only. Unauthorized distribution is strictly prohibited.
Authors
228 Article
male ( %) female ( %) nonsmoker ( %) ex-smoker ( %) smoker ( %)
smoking history
HbA1c ( %) Hb (g/dL) BMI (kg/m2) WBC (103/mm3)
Control group (n = 26)
P-value
61.5 ± 8.3 17 (70.8) 7 (29.2) 5 (20.8) 17 (70.8) 2 (8.3) 7.4 ± 1.2 11.6 ± 1.5 23.4 ± 8.2 8.3 ± 2.5
62.7 ± 5.9 19 (73.1) 7 (26.9) 6 (23.1) 19 (73.1) 1 (3.8) 7.5 ± 1.1 11.4 ± 1.3 22.7 ± 5.6 7.9 ± 1.6
0.16 0.86
Treatment group ulcer size (cm2)
duration of ulcer (years) wagner grade ulcer location cause of ulcer
mean ± SD median range (min–max) mean ± SD median range (min–max) grade I ( %) grade II ( %) dorsal (forefoot:midfoot:hindfoot) plantar (forefoot:midfoot:hindfoot) trauma ( %) pressure by shoes ( %) unknown ( %)
Table 1 Patients characteristics for the Mepilex Lite dressing treated and control groups.
0.80
0.26 0.78 0.59 0.72
Control group
(n = 24)
(n = 26)
4.3 ± 2.7 2.1 1.2–16.6 0.35 ± 0.17 0.21 0.11–1.05 9 (37.5) 15 (62.5) 14 (10:1:3) 10 (7:1:2) 4 (16.7) 13 (54.2) 7 (29.2)
5.0 ± 1.9 2.0 1.4–20.5 0.41 ± 0.23 0.22 0.12–1.57 12 (46.2) 14 (53.8) 16 (11:1:4) 10 (8:1:1) 7 (26.9) 15 (57.7) 4 (15.4)
P-value
Table 2 Clinical characteristics of the ulcers at baseline.
0.56
0.88
0.54 0.32 0.43
SD, standard deviation
Patients and Methods
▼
Table 3 Comorbidity of patients.
Ethics statement
Treatment
Control group
This study was approved by our Institutional Review Boards (IRBs) for Affiliated Hospital of Binzhou Medical College, and conducted in accordance with the Helsinki Declaration of Human Rights. Written informed consents were obtained from all the patients in accordance with the regulations of IRBs.
group (n = 24)
(n = 26)
11 18 6 3 2 2 1
14 21 9 5 3 2 2
Patients Potential participants were recruited from the Department of Endocrinology, the Affiliated Hospital of Binzhou Medical College between January 2010 and December 2012. All participants who met the inclusion criteria were recruited and independently randomized to either Mepilex Lite dressing treatment group or control group. They were ≥ 18 years of age, male or female, with evidence of peripheral neuropathy, Wagner grade 1 or 2, ankle brachial pressure indexes of > 0.5 and a diabetic foot ulcer of ≥ 4 weeks’ duration. Participants who presented with acute ischaemia (ankle brachial pressure index < 0.5, rest pain and necrosis), grade 3 or 4 severe soft tissue infection [8], osteomyelitis or with a wound clinically ‘probing to bone’ were excluded. Participants who had significant or end-stage renal disease (serum creatinine levels > 200 μmol/L, or on haemodialysis) were also excluded. The relevant patient information at ▶ Table 1–3. baseline in the 2 groups is shown in ●
Pressure off-loading All patients with ulcers on weight-bearing sites or sites otherwise subjected to pressure when wearing shoes had pressure off-loaded with the use of foam dressings with a hole on the ulcer site and footwear with cushioning insoles. If clinically
cardiac disorder hypertension renal disorder ophthalmic disorder arthritis metabolic disorder pulmonary disorder
P-value 0.34 0.89 0.74 0.12 0.25 0.67 0.46
appropriate, the use of other weight off-loading devices, such as ▶ Table 4). crutches, half-shoes and wheelchairs, was allowed (●
Techniques Before the study, all ulcers were subjected to sharp debridement to remove necrotic or hyper keratinized tissue and to control infection. The debridement technique was standardized during an initial meeting of the investigators, at which all investigators were instructed to debride the wound until healthy bleeding tissue was reached. In the treatment and control group, the ulcer was cleaned with 3 % hydrogen peroxide and saline solution to remove dirt and other debris before applying Mepilex Lite dressing and vaseline gauze. Dressing changes and application of the Mepilex Lite were scheduled at weekly intervals. In the control group, vaseline gauze (a moistened gauze, Tego Science) was applied as the primary dressing over the wound. Control group dressing changes were scheduled as in the Mepilex Lite dressing group. No concomitant biological or biochemical therapy, including growth factors, was allowed. At every visit, the patients’ feet were examined to check for cuts, sores, blisters,
Zhang Y, Xing S-Z. Treatment of Diabetic Foot … Exp Clin Endocrinol Diabetes 2014; 122: 227–230
This document was downloaded for personal use only. Unauthorized distribution is strictly prohibited.
age (years) gender
Treatment group (n = 24)
Article 229
Control group (n = 26)
P-value
13 5 3 3
15 6 3 2
0.894 0.878 0.926 0.609
redness, calluses, or any other problems. The feet were washed with saline, and corns and calluses were removed gently. Toenails were cut when needed. Moisturizing lotion was applied to prevent the skin from becoming dry. The patients were made to wear soft, absorbent socks or slippers in order to protect their feet from injuries.
The wounds were evaluated weekly until complete wound closure or the 12th week visit if not completely healed. The primary efficacy criterion was the percentage of patients who achieved complete wound closure within the 12-week study period. The secondary efficacy criterion was the mean percentage of wound area reduction and the mean time required for complete closure in patients who achieved complete healing within 12 weeks. Complete closure was defined as a completely epithelialized state in the absence of discharge and which enabled the patient to shower. The wound area was determined by means of the Visitrak Digital Planimetry Wound Measurement System (Smith & Nephew, Hull, UK) by the researchers of the study. Pain measurement was performed at the screening visit and again at 4-week intervals using the Short-Form McGill Pain Questionnaire and Visual Analogue Scale [9, 10]. Safety was also monitored at the time points indicated by evaluating adverse event reports, laboratory assessments, and vital signs. Ulcer recurrences and side effects of the healed ulcers were monitored for 6 months after healing by reviewing medical records and/or telephone interviews. Final results of the unhealed ulcers were also followed up accordingly.
Statistical analyses Statistical comparisons for the healing rate, the percentage of wound area reduction, and the time to complete ulcer healing were performed. The median time to closure was also estimated by using the Kaplan-Meier method. A P-value < 0.05 was considered significant. Data are given as the mean ± standard deviation.
Results
▼
Overall, 87 participants were considered eligible for screening. 33 did not meet the inclusion criteria and 4 patients refused to participate. A total of 50 participants were enrolled in the randomized controlled trial. 46 out of 50 (92 %) participants completed the study (22 in the Mepilex Lite dressing group and 24 in the control group) and 3/50 (6 %) participants were withdrawn (1 in the Mepilex Lite dressing group and 2 in the control group as a result of infection, and 1 individual lost to follow-up). Their ▶ Table 1 shows the data were included in the study analysis. ● main characteristics of case-control populations. The gender, age distribution and laboratory assay results in case and control population group are not statistically different.
1.0
0.8
Probability
Evaluation
Table 4 Distribution of pressure off-loading strategies.
0.6
0.4
P =0.038
0.2
0.0 0.00
20.00
40.00
60.00
80.00
100.00
Follow-Up Time (days) Mepilex group
Control group
Fig. 1 Kaplan-Meier diagram showing the results on time to wound closure. Survival analysis using a Kaplan-Meier test confirmed statistically significant difference in ulcer closure at the study endpoint of 12 weeks, and median time to complete ulcer healing was 49.9 ± 4.1 days for the Mepilex Lite dressing group and 65.5 ± 4.2 days for the control groups (P = 0.038).
After 12 weeks, 18 out of 24 ulcers closed in the Mepilex Lite dressing group compared with 16/26 in the control group. Although, the difference observed regarding wound closure is only minor between 2 groups, while the time to would closure is much shorter in the Mepilex Lite group. Survival analysis using a Kaplan-Meier test confirmed statistically significant difference in ulcer closure at the study endpoint of 12 weeks, and median time to complete ulcer healing was 49.9 ± 4.1 days for the Mepilex Lite dressing group and 65.5 ± 4.2 days for the control ▶ Fig. 1). Pain levels were reported following groups (P = 0.038) (● analysis of a McGill Pain Questionnaire and Visual Analogue Score. At screening, in the McGill Pain Questionnaire 18/24 subjects (75 %) in the Mepilex Lite dressing group reported no pain compared with 15/26 of the control group (58 %) (P = 0.20). The mean percentages of wound area reduction were 89 ± 23 % and 72 ± 41 % in the Mepilex Lite dressing and control groups, respectively (P < 0.05). Adverse events occurred in 3 patients (12.4 %) in the Mepilex Lite dressing group as follows: wound infections (n = 1), pruritis (n = 1), and insomnia (n = 1). In the control group, adverse events were reported in 4 patients (15.4 %) as follows: wound infections (n = 3) and upper respiratory tract infection (n = 1). The presence of infection diagnosed by a positive swab result and clinical examination was compared between the 2 groups. However, none of these events was related to the Mepilex Lite dressings and no significant differences were noted between the 2 groups (P = 0.43). 12 weeks and 24 weeks following completion of the
Zhang Y, Xing S-Z. Treatment of Diabetic Foot … Exp Clin Endocrinol Diabetes 2014; 122: 227–230
This document was downloaded for personal use only. Unauthorized distribution is strictly prohibited.
foam dressing with a hole foam dressing with a hole + use of a crutch foam dressing with a hole + use of a wheelchair foam dressing with a hole + use of a crutch + use of a wheelchair
Treatment group (n = 24)
230 Article
Discussion
▼
In this study, we compared the effects of a soft silicone dressing with the effects of vaseline gauze wound dressing when applied topically to diabetic foot ulcers. Although, no statistically significant differences were found in the percent changes in pain between 2 groups of diabetes patients who were treated with either Mepilex Lite dressing or vaseline gauze dressings for the 12-week study period. However, Mepilex Lite dressing significantly improved the complete ulcer healing rate than vaseline gauze wound dressing. The Kaplan-Meier median times to complete closure were 49.9 and 65.5 days for the Mepilex Lite dressing and control groups, respectively. No adverse events related to the treatment occurred. Management of diabetic foot ulcers is multi-faceted, addressing all the factors that may affect or obstruct healing. This includes ensuring adequate blood supply, management and prevention of infections and bacterial burden, control of blood glucose levels and nutritional status, wound debridement, careful selection of appropriate dressings to achieve the appropriate wound environment and a decrease or elimination of excessive plantar pressures [11–18]. Despite all efforts regarding wound dressings, the most important fact for successful treating is still debridement and strict adherence of patient to offload. Seaman [19] stated that an ideal wound dressing maintains a moist wound environment, absorbs excess exudate, eliminates dead space, does not harm the wound and provides thermal insulation and a bacterial barrier. It would also seem important that a dressing should not exacerbate wound breakdown by increasing plantar pressure or decreasing the vascular supply. The choice of dressing type may, therefore, be an important consideration in wound management. The present study had some limitations. First, wound evaluation was performed in a single-blind fashion. The wound evaluators knew whether or not the patients were in the Mepilex Lite dressing group, which might have affected the results. However, this was unavoidable because the wound evaluators could discriminate between the Mepilex Lite dressing and the vaseline gauzes. Second, the primary etiology (neuropathic vs. neuroischemic) and anatomical location of the ulcers, which may be important and crucial in the management of diabetic foot ulcers, were not separately selected in the study design. Third, studies are necessary to determine the optimal interval for Mepilex Lite dressing application. Application of the Mepilex Lite dressing more frequently than once a week might reduce the time to healing.
Improvement in the understanding of wound healing mechanisms and the field of bioengineering have led to the development of various advanced products, such as growth factors and living skin equivalents [20]. Finally, the analysis conducted here highlights that Mepilex Lite dressing may be safe and effective for the treatment of diabetic foot ulcers.
Author disclosure statement: No competing financial interests exist. References 1 Mason J, O’Keeffe C, Hutchinson A et al. A systematic review of foot ulcer in patients with type 2 diabetes mellitus. Ii: Treatment. Diabetic medicine 1999; 16: 889–909 2 New J, McDowell D, Burns E et al. Problem of amputations in patients with newly diagnosed diabetes mellitus. Diabetic medicine 1998; 15: 760–764 3 Boulton AJ, Vileikyte L, Ragnarson-Tennvall G et al. The global burden of diabetic foot disease. The Lancet 2005; 366: 1719–1724 4 ONFERENCEREPORT C. Consensus development conference on diabetic foot wound care. Diabetes Care 1999; 22: 1355 5 Steed DL, Attinger C, Colaizzi T et al. Guidelines for the treatment of diabetic ulcers. Wound repair and regeneration 2006; 14: 680–692 6 White R. Evidence for atraumatic soft silicone wound dressing use. Wounds uK 2005; 1: 104–109 7 Kennedy-Evans KL. An innovative solution for skin tears: A case study. Ostomy/wound management 2004; 50: 9 8 Lipsky BA, Berendt AR, Deery HG et al. Diagnosis and treatment of diabetic foot infections. Clinical Infectious Diseases 2004; 39: 885–910 9 Carlsson AM. Assessment of chronic pain. I. Aspects of the reliability and validity of the visual analogue scale. Pain 1983; 16: 87–101 10 Melzack R. The short-form mcgill pain questionnaire. Pain 1987; 30: 191–197 11 van Schie CM. A review of the biomechanics of the diabetic foot. The international journal of lower extremity wounds 2005; 4: 160–170 12 Reiber GE, Vileikyte L, Boyko Ed et al. Causal pathways for incident lower-extremity ulcers in patients with diabetes from two settings. Diabetes Care 1999; 22: 157–162 13 Armstrong DG, Athanasiou KA. The edge effect: How and why wounds grow in size and depth. Clinics in podiatric medicine and surgery 1998; 15: 105 14 Armstrong DG, Lavery LA. Diabetic foot ulcers: Prevention, diagnosis and classification. American family physician 1998; 57: 1325–1332, 1337–1338 15 Armstrong DG, Lavery LA, Nixon BP et al. It’s not what you put on, but what you take off: Techniques for debriding and off-loading the diabetic foot wound. Clinical Infectious Diseases 2004; 39: S92–S99 16 Armstrong DG, Lavery LA, Vazquez JR et al. How and why to surgically debride neuropathic diabetic foot wounds. Journal of the American Podiatric Medical Association 2002; 92: 402–404 17 Abbott CA, Vileikyte L, Williamson S et al. Multicenter study of the incidence of and predictive risk factors for diabetic neuropathic foot ulceration. Diabetes Care 1998; 21: 1071–1075 18 Apelqvist J, Larsson J. What is the most effective way to reduce incidence of amputation in the diabetic foot? Diabetes/metabolism research and reviews 2000; 16: S75–S83 19 Seaman S. Dressing selection in chronic wound management. Journal of the American Podiatric Medical Association 2002; 92: 24–33 20 Veves A, Falanga V, Armstrong DG et al. Graftskin, a human skin equivalent, is effective in the management of noninfected neuropathic diabetic foot ulcers a prospective randomized multicenter clinical trial. Diabetes Care 2001; 24: 290–295
Zhang Y, Xing S-Z. Treatment of Diabetic Foot … Exp Clin Endocrinol Diabetes 2014; 122: 227–230
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treatment phase of the study, 1 ulcer recurred in the Mepilex Lite dressing group and none in the control group.
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Treatment of Diabetic Foot Ulcers using Mepilex Lite Dressings: A Pilot Study
Affiliations
Key words ▶ foot ulcers ● ▶ diabetes mellitus ● ▶ Mepilex Lite dressing ● ▶ wound healing ● ▶ nursing ●
received 12.12.2013 first decision 29.01.2014 accepted 05.02.2014 Bibliography DOI http://dx.doi.org/ 10.1055/s-0034-1370918 Published online: March 12, 2014 Exp Clin Endocrinol Diabetes 2014; 122: 227–230 © J. A. Barth Verlag in Georg Thieme Verlag KG Stuttgart · New York ISSN 0947-7349 Correspondence Y. Zhang Department of Nutrition School of Clinical Medicine Binzhou Medical College No.661 Yellow-River Second Street Binzhou 256603 China Tel.: + 86/0543/3258 870 Fax: + 86/0543/3258 870 [email protected]
Y. Zhang1, S.-Z. Xing2 1 2
Department of Nutrition, School of Clinical Medicine, Binzhou Medical College, Binzhou, China Department of Oncology, School of Clinical Medicine, Binzhou Medical College, Binzhou, China
Abstract
▼
Background: 5–10 % diabetes patients will develop diabetic foot ulceration at some time during the life. The purpose of this study was to compare the effectiveness of Mepilex Lite dressings and vaseline gauze care in the healing of foot ulcers in diabetic patients. Methods: This was a randomized controlled trial, and a sample of 50 diabetic patients who had developed foot ulcers was assessed. Comparisons were made regarding parameters related to wound healing, including healing time and wound pain, and also regarding the adverse events.
Introduction
▼
Diabetic foot ulceration is estimated to occur in 5–10 % of the population with diabetes, and is one of the most common complications of diabetes mellitus [1]. It is not only a typical complication in later stages of diabetes but also occur in patients with newly diagnosed disease [2]. Foot complications in people with diabetes can be difficult to treat and conventional therapies often fail, leading to lower limb amputations [3]. Thus, prevention of this condition is of paramount importance. The current standard treatment for diabetic foot ulcers consists of debridement, control of infection, pressure relief, and lower extremity revascularization when required [4]. Dressings are widely used in wound care, with the aim of protecting and managing the wound and promoting healing. Guidelines for the treatment of diabetic foot ulcers maintain that clinical judgement should be used to select a moist wound dressing [5]. Several dressing types are available to treat complex wounds including diabetic foot ulcers.
Results: The results showed that foot ulcers in the study group (Mepilex Lite, 24 patients) healed in a median of 49.9 days, which was significantly different from the healing time in the control group (median, 65.5 days, 26 patients; P = 0.038). No statistically significant differences were detected between the 2 groups with pain. However, Mepilex Lite dressings significantly reduced wound area (P < 0.05). Conclusions: The researchers conclude that Mepilex Lite dressing provides a promising alternative to diabetic foot ulcers and is worthy of further research.
Mepilex® Lite (Mölnlycke Health Care, Gothenburg, Sweden) is one of a number of dressings that created by combining Safetac® soft silicone technology to ensure that they adhere to intact dry skin but not to moist wound beds [6]. Mepilex Lite could be used on a wide range of acute wounds (e. g. skin tears, abrasions and second degree burns), chronic wounds, skin disorders (e. g. epidermolysis bullosa), as well as for the fixation of grafts. It can be left in place for up to 14 days, with the secondary dressing changed as frequently as required, so avoiding disturbance of the wound bed [7]. The purpose of this investigation was to determine the efficacy of Mepilex Lite dressings on healing in diabetic foot ulcers by conducting a randomized, controlled trial analyzed on an intention-to-treat basis. The primary endpoint was complete (100 %) wound closure. Pain and the occurrence of adverse events were also considered.
Zhang Y, Xing S-Z. Treatment of Diabetic Foot … Exp Clin Endocrinol Diabetes 2014; 122: 227–230
This document was downloaded for personal use only. Unauthorized distribution is strictly prohibited.
Authors
228 Article
male ( %) female ( %) nonsmoker ( %) ex-smoker ( %) smoker ( %)
smoking history
HbA1c ( %) Hb (g/dL) BMI (kg/m2) WBC (103/mm3)
Control group (n = 26)
P-value
61.5 ± 8.3 17 (70.8) 7 (29.2) 5 (20.8) 17 (70.8) 2 (8.3) 7.4 ± 1.2 11.6 ± 1.5 23.4 ± 8.2 8.3 ± 2.5
62.7 ± 5.9 19 (73.1) 7 (26.9) 6 (23.1) 19 (73.1) 1 (3.8) 7.5 ± 1.1 11.4 ± 1.3 22.7 ± 5.6 7.9 ± 1.6
0.16 0.86
Treatment group ulcer size (cm2)
duration of ulcer (years) wagner grade ulcer location cause of ulcer
mean ± SD median range (min–max) mean ± SD median range (min–max) grade I ( %) grade II ( %) dorsal (forefoot:midfoot:hindfoot) plantar (forefoot:midfoot:hindfoot) trauma ( %) pressure by shoes ( %) unknown ( %)
Table 1 Patients characteristics for the Mepilex Lite dressing treated and control groups.
0.80
0.26 0.78 0.59 0.72
Control group
(n = 24)
(n = 26)
4.3 ± 2.7 2.1 1.2–16.6 0.35 ± 0.17 0.21 0.11–1.05 9 (37.5) 15 (62.5) 14 (10:1:3) 10 (7:1:2) 4 (16.7) 13 (54.2) 7 (29.2)
5.0 ± 1.9 2.0 1.4–20.5 0.41 ± 0.23 0.22 0.12–1.57 12 (46.2) 14 (53.8) 16 (11:1:4) 10 (8:1:1) 7 (26.9) 15 (57.7) 4 (15.4)
P-value
Table 2 Clinical characteristics of the ulcers at baseline.
0.56
0.88
0.54 0.32 0.43
SD, standard deviation
Patients and Methods
▼
Table 3 Comorbidity of patients.
Ethics statement
Treatment
Control group
This study was approved by our Institutional Review Boards (IRBs) for Affiliated Hospital of Binzhou Medical College, and conducted in accordance with the Helsinki Declaration of Human Rights. Written informed consents were obtained from all the patients in accordance with the regulations of IRBs.
group (n = 24)
(n = 26)
11 18 6 3 2 2 1
14 21 9 5 3 2 2
Patients Potential participants were recruited from the Department of Endocrinology, the Affiliated Hospital of Binzhou Medical College between January 2010 and December 2012. All participants who met the inclusion criteria were recruited and independently randomized to either Mepilex Lite dressing treatment group or control group. They were ≥ 18 years of age, male or female, with evidence of peripheral neuropathy, Wagner grade 1 or 2, ankle brachial pressure indexes of > 0.5 and a diabetic foot ulcer of ≥ 4 weeks’ duration. Participants who presented with acute ischaemia (ankle brachial pressure index < 0.5, rest pain and necrosis), grade 3 or 4 severe soft tissue infection [8], osteomyelitis or with a wound clinically ‘probing to bone’ were excluded. Participants who had significant or end-stage renal disease (serum creatinine levels > 200 μmol/L, or on haemodialysis) were also excluded. The relevant patient information at ▶ Table 1–3. baseline in the 2 groups is shown in ●
Pressure off-loading All patients with ulcers on weight-bearing sites or sites otherwise subjected to pressure when wearing shoes had pressure off-loaded with the use of foam dressings with a hole on the ulcer site and footwear with cushioning insoles. If clinically
cardiac disorder hypertension renal disorder ophthalmic disorder arthritis metabolic disorder pulmonary disorder
P-value 0.34 0.89 0.74 0.12 0.25 0.67 0.46
appropriate, the use of other weight off-loading devices, such as ▶ Table 4). crutches, half-shoes and wheelchairs, was allowed (●
Techniques Before the study, all ulcers were subjected to sharp debridement to remove necrotic or hyper keratinized tissue and to control infection. The debridement technique was standardized during an initial meeting of the investigators, at which all investigators were instructed to debride the wound until healthy bleeding tissue was reached. In the treatment and control group, the ulcer was cleaned with 3 % hydrogen peroxide and saline solution to remove dirt and other debris before applying Mepilex Lite dressing and vaseline gauze. Dressing changes and application of the Mepilex Lite were scheduled at weekly intervals. In the control group, vaseline gauze (a moistened gauze, Tego Science) was applied as the primary dressing over the wound. Control group dressing changes were scheduled as in the Mepilex Lite dressing group. No concomitant biological or biochemical therapy, including growth factors, was allowed. At every visit, the patients’ feet were examined to check for cuts, sores, blisters,
Zhang Y, Xing S-Z. Treatment of Diabetic Foot … Exp Clin Endocrinol Diabetes 2014; 122: 227–230
This document was downloaded for personal use only. Unauthorized distribution is strictly prohibited.
age (years) gender
Treatment group (n = 24)
Article 229
Control group (n = 26)
P-value
13 5 3 3
15 6 3 2
0.894 0.878 0.926 0.609
redness, calluses, or any other problems. The feet were washed with saline, and corns and calluses were removed gently. Toenails were cut when needed. Moisturizing lotion was applied to prevent the skin from becoming dry. The patients were made to wear soft, absorbent socks or slippers in order to protect their feet from injuries.
The wounds were evaluated weekly until complete wound closure or the 12th week visit if not completely healed. The primary efficacy criterion was the percentage of patients who achieved complete wound closure within the 12-week study period. The secondary efficacy criterion was the mean percentage of wound area reduction and the mean time required for complete closure in patients who achieved complete healing within 12 weeks. Complete closure was defined as a completely epithelialized state in the absence of discharge and which enabled the patient to shower. The wound area was determined by means of the Visitrak Digital Planimetry Wound Measurement System (Smith & Nephew, Hull, UK) by the researchers of the study. Pain measurement was performed at the screening visit and again at 4-week intervals using the Short-Form McGill Pain Questionnaire and Visual Analogue Scale [9, 10]. Safety was also monitored at the time points indicated by evaluating adverse event reports, laboratory assessments, and vital signs. Ulcer recurrences and side effects of the healed ulcers were monitored for 6 months after healing by reviewing medical records and/or telephone interviews. Final results of the unhealed ulcers were also followed up accordingly.
Statistical analyses Statistical comparisons for the healing rate, the percentage of wound area reduction, and the time to complete ulcer healing were performed. The median time to closure was also estimated by using the Kaplan-Meier method. A P-value < 0.05 was considered significant. Data are given as the mean ± standard deviation.
Results
▼
Overall, 87 participants were considered eligible for screening. 33 did not meet the inclusion criteria and 4 patients refused to participate. A total of 50 participants were enrolled in the randomized controlled trial. 46 out of 50 (92 %) participants completed the study (22 in the Mepilex Lite dressing group and 24 in the control group) and 3/50 (6 %) participants were withdrawn (1 in the Mepilex Lite dressing group and 2 in the control group as a result of infection, and 1 individual lost to follow-up). Their ▶ Table 1 shows the data were included in the study analysis. ● main characteristics of case-control populations. The gender, age distribution and laboratory assay results in case and control population group are not statistically different.
1.0
0.8
Probability
Evaluation
Table 4 Distribution of pressure off-loading strategies.
0.6
0.4
P =0.038
0.2
0.0 0.00
20.00
40.00
60.00
80.00
100.00
Follow-Up Time (days) Mepilex group
Control group
Fig. 1 Kaplan-Meier diagram showing the results on time to wound closure. Survival analysis using a Kaplan-Meier test confirmed statistically significant difference in ulcer closure at the study endpoint of 12 weeks, and median time to complete ulcer healing was 49.9 ± 4.1 days for the Mepilex Lite dressing group and 65.5 ± 4.2 days for the control groups (P = 0.038).
After 12 weeks, 18 out of 24 ulcers closed in the Mepilex Lite dressing group compared with 16/26 in the control group. Although, the difference observed regarding wound closure is only minor between 2 groups, while the time to would closure is much shorter in the Mepilex Lite group. Survival analysis using a Kaplan-Meier test confirmed statistically significant difference in ulcer closure at the study endpoint of 12 weeks, and median time to complete ulcer healing was 49.9 ± 4.1 days for the Mepilex Lite dressing group and 65.5 ± 4.2 days for the control ▶ Fig. 1). Pain levels were reported following groups (P = 0.038) (● analysis of a McGill Pain Questionnaire and Visual Analogue Score. At screening, in the McGill Pain Questionnaire 18/24 subjects (75 %) in the Mepilex Lite dressing group reported no pain compared with 15/26 of the control group (58 %) (P = 0.20). The mean percentages of wound area reduction were 89 ± 23 % and 72 ± 41 % in the Mepilex Lite dressing and control groups, respectively (P < 0.05). Adverse events occurred in 3 patients (12.4 %) in the Mepilex Lite dressing group as follows: wound infections (n = 1), pruritis (n = 1), and insomnia (n = 1). In the control group, adverse events were reported in 4 patients (15.4 %) as follows: wound infections (n = 3) and upper respiratory tract infection (n = 1). The presence of infection diagnosed by a positive swab result and clinical examination was compared between the 2 groups. However, none of these events was related to the Mepilex Lite dressings and no significant differences were noted between the 2 groups (P = 0.43). 12 weeks and 24 weeks following completion of the
Zhang Y, Xing S-Z. Treatment of Diabetic Foot … Exp Clin Endocrinol Diabetes 2014; 122: 227–230
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foam dressing with a hole foam dressing with a hole + use of a crutch foam dressing with a hole + use of a wheelchair foam dressing with a hole + use of a crutch + use of a wheelchair
Treatment group (n = 24)
230 Article
Discussion
▼
In this study, we compared the effects of a soft silicone dressing with the effects of vaseline gauze wound dressing when applied topically to diabetic foot ulcers. Although, no statistically significant differences were found in the percent changes in pain between 2 groups of diabetes patients who were treated with either Mepilex Lite dressing or vaseline gauze dressings for the 12-week study period. However, Mepilex Lite dressing significantly improved the complete ulcer healing rate than vaseline gauze wound dressing. The Kaplan-Meier median times to complete closure were 49.9 and 65.5 days for the Mepilex Lite dressing and control groups, respectively. No adverse events related to the treatment occurred. Management of diabetic foot ulcers is multi-faceted, addressing all the factors that may affect or obstruct healing. This includes ensuring adequate blood supply, management and prevention of infections and bacterial burden, control of blood glucose levels and nutritional status, wound debridement, careful selection of appropriate dressings to achieve the appropriate wound environment and a decrease or elimination of excessive plantar pressures [11–18]. Despite all efforts regarding wound dressings, the most important fact for successful treating is still debridement and strict adherence of patient to offload. Seaman [19] stated that an ideal wound dressing maintains a moist wound environment, absorbs excess exudate, eliminates dead space, does not harm the wound and provides thermal insulation and a bacterial barrier. It would also seem important that a dressing should not exacerbate wound breakdown by increasing plantar pressure or decreasing the vascular supply. The choice of dressing type may, therefore, be an important consideration in wound management. The present study had some limitations. First, wound evaluation was performed in a single-blind fashion. The wound evaluators knew whether or not the patients were in the Mepilex Lite dressing group, which might have affected the results. However, this was unavoidable because the wound evaluators could discriminate between the Mepilex Lite dressing and the vaseline gauzes. Second, the primary etiology (neuropathic vs. neuroischemic) and anatomical location of the ulcers, which may be important and crucial in the management of diabetic foot ulcers, were not separately selected in the study design. Third, studies are necessary to determine the optimal interval for Mepilex Lite dressing application. Application of the Mepilex Lite dressing more frequently than once a week might reduce the time to healing.
Improvement in the understanding of wound healing mechanisms and the field of bioengineering have led to the development of various advanced products, such as growth factors and living skin equivalents [20]. Finally, the analysis conducted here highlights that Mepilex Lite dressing may be safe and effective for the treatment of diabetic foot ulcers.
Author disclosure statement: No competing financial interests exist. References 1 Mason J, O’Keeffe C, Hutchinson A et al. A systematic review of foot ulcer in patients with type 2 diabetes mellitus. Ii: Treatment. Diabetic medicine 1999; 16: 889–909 2 New J, McDowell D, Burns E et al. Problem of amputations in patients with newly diagnosed diabetes mellitus. Diabetic medicine 1998; 15: 760–764 3 Boulton AJ, Vileikyte L, Ragnarson-Tennvall G et al. The global burden of diabetic foot disease. The Lancet 2005; 366: 1719–1724 4 ONFERENCEREPORT C. Consensus development conference on diabetic foot wound care. Diabetes Care 1999; 22: 1355 5 Steed DL, Attinger C, Colaizzi T et al. Guidelines for the treatment of diabetic ulcers. Wound repair and regeneration 2006; 14: 680–692 6 White R. Evidence for atraumatic soft silicone wound dressing use. Wounds uK 2005; 1: 104–109 7 Kennedy-Evans KL. An innovative solution for skin tears: A case study. Ostomy/wound management 2004; 50: 9 8 Lipsky BA, Berendt AR, Deery HG et al. Diagnosis and treatment of diabetic foot infections. Clinical Infectious Diseases 2004; 39: 885–910 9 Carlsson AM. Assessment of chronic pain. I. Aspects of the reliability and validity of the visual analogue scale. Pain 1983; 16: 87–101 10 Melzack R. The short-form mcgill pain questionnaire. Pain 1987; 30: 191–197 11 van Schie CM. A review of the biomechanics of the diabetic foot. The international journal of lower extremity wounds 2005; 4: 160–170 12 Reiber GE, Vileikyte L, Boyko Ed et al. Causal pathways for incident lower-extremity ulcers in patients with diabetes from two settings. Diabetes Care 1999; 22: 157–162 13 Armstrong DG, Athanasiou KA. The edge effect: How and why wounds grow in size and depth. Clinics in podiatric medicine and surgery 1998; 15: 105 14 Armstrong DG, Lavery LA. Diabetic foot ulcers: Prevention, diagnosis and classification. American family physician 1998; 57: 1325–1332, 1337–1338 15 Armstrong DG, Lavery LA, Nixon BP et al. It’s not what you put on, but what you take off: Techniques for debriding and off-loading the diabetic foot wound. Clinical Infectious Diseases 2004; 39: S92–S99 16 Armstrong DG, Lavery LA, Vazquez JR et al. How and why to surgically debride neuropathic diabetic foot wounds. Journal of the American Podiatric Medical Association 2002; 92: 402–404 17 Abbott CA, Vileikyte L, Williamson S et al. Multicenter study of the incidence of and predictive risk factors for diabetic neuropathic foot ulceration. Diabetes Care 1998; 21: 1071–1075 18 Apelqvist J, Larsson J. What is the most effective way to reduce incidence of amputation in the diabetic foot? Diabetes/metabolism research and reviews 2000; 16: S75–S83 19 Seaman S. Dressing selection in chronic wound management. Journal of the American Podiatric Medical Association 2002; 92: 24–33 20 Veves A, Falanga V, Armstrong DG et al. Graftskin, a human skin equivalent, is effective in the management of noninfected neuropathic diabetic foot ulcers a prospective randomized multicenter clinical trial. Diabetes Care 2001; 24: 290–295
Zhang Y, Xing S-Z. Treatment of Diabetic Foot … Exp Clin Endocrinol Diabetes 2014; 122: 227–230
This document was downloaded for personal use only. Unauthorized distribution is strictly prohibited.
treatment phase of the study, 1 ulcer recurred in the Mepilex Lite dressing group and none in the control group.
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