Allogeneic keratinocyte for intractable chronic diabetic foot ulcers: A prospective observational study

Chronic diabetic foot ulcers (DFUs) are a common problem in patients with diabetes and are often difficult to treat. The application of newly developed dressing material in patients with chronic DFUs has been reported to be effective. The purpose of this study was to evaluate the usefulness of allogeneic keratinocyte treatment for chronic DFUs. We performed weekly allogeneic keratinocyte treatment for up to 12 weeks in 71 patients with intractable DFUs. We investigated healing rate, wound‐healing velocity, and time to 50% wound size reduction and analysed factors affecting ulcer healing. Fifty‐six patients (78.8%) had complete wound healing. Forty‐six patients (64.7%) showed complete healing within an average of 6.1 weeks, and 10 patients (14.1%) showed partial healing with an average 35.5% reduction vs initial size at the end of follow up. The 10 patients who showed partial healing continued to receive treatment after the 12‐week study period. The mean time to complete wound healing was 7.8 weeks. Fifteen patients (21.1%) experienced treatment failure because of infection, local necrosis, no change in ulcer size, or osteomyelitis during the follow‐up period. No adverse events were observed. Allogeneic keratinocyte treatment is effective for chronic, difficult‐to‐treat DFUs.     

Use of locally made off‐loading techniques for diabetic plantar foot ulcer in Karachi,Pakistan

The aim of this study was to evaluate the effectiveness of applying locally made pressure off‐loading techniques on plantar foot ulcer in individuals with diabetes. This prospective study of 70 diabetic patients was conducted at the foot clinic of Baqai Institute of Diabetology & Endocrinology. Plantar foot ulcer, stages 1A and 2A according to the University of Texas classification, was treated by using three off‐loading techniques: modified foot wear (sandal), modified plaster of Paris cast with plywood platform and Scotchcast boot. The outcome was assessed at either complete wound healing (defined as complete epithelialisation) or at 12 weeks, whichever came first. Of the 70 patients, 24 were in modified foot wear group, 23 in modified plaster of Paris cast and 23 in Scotchcast boot group. There was almost equal proportion of patients healed within 12 weeks period treated with these three off‐loading techniques, i.e. 22 (95·7%) for modified foot wear group, 19 (95%) for modified plaster cast and 18 (94·7%) for Scotchcast boot group. No significant difference was observed in median healing time and cumulative wound survival at 12 weeks in the three off‐loading techniques. Modified foot wear group was the most cost effective ($7) amongst the three off‐loading techniques. It is concluded that in this cohort, no significant difference in healing time was observed in the three off‐loading techniques, although modified foot wear (sandal) was found to be a more cost‐effective treatment modality.     

A multicentre prospective randomised controlled comparative parallel study of dehydrated human umbilical cord (EpiCord) allograft for the treatment of diabetic foot ulcers

The aim of this study was to determine the safety and effectiveness of dehydrated human umbilical cord allograft (EpiCord) compared with alginate wound dressings for the treatment of chronic, non‐healing diabetic foot ulcers (DFU). A multicentre, randomised, controlled, clinical trial was conducted at 11 centres in the United States. Individuals with a confirmed diagnosis of Type 1 or Type 2 diabetes presenting with a 1 to 15 cm² ulcer located below the ankle that had been persisting for at least 30 days were eligible for the 14‐day study run‐in phase. After 14 days of weekly debridement, moist wound therapy, and off‐loading, those with ≤30% wound area reduction post‐debridement (n = 155) were randomised in a 2:1 ratio to receive a weekly application of EpiCord (n = 101) or standardised therapy with alginate wound dressing, non‐adherent silicone dressing, absorbent non‐adhesive hydropolymer secondary dressing, and gauze bandage roll (n = 54). All wounds continued to have appropriate off‐loading during the treatment phase of the study. Study visits were conducted for 12 weeks. At each weekly visit, the DFU was cleaned and debrided as necessary, with the wound photographed pre‐ and post‐debridement and measured before the application of treatment group‐specific dressings. A follow‐up visit was performed at week 16. The primary study end point was the percentage of complete closure of the study ulcer within 12 weeks, as assessed by Silhouette camera. Data for randomised subjects meeting study inclusion criteria were included in an intent‐to‐treat (ITT) analysis. Additional analysis was conducted on a group of subjects (n = 134) who completed the study per protocol (PP) (EpiCord, n = 86, alginate, n = 48) and for those subjects receiving adequate debridement (EpiCord, n = 67, alginate, n = 40). ITT analysis showed that DFUs treated with EpiCord were more likely to heal within 12 weeks than those receiving alginate dressings, 71 of 101 (70%) vs 26 of 54 (48%) for EpiCord and alginate dressings, respectively, P = 0.0089. Healing rates at 12 weeks for subjects treated PP were 70 of 86 (81%) for EpiCord‐treated and 26 of 48 (54%) for alginate‐treated DFUs, P = 0.0013. For those DFUs that received adequate debridement (n = 107, ITT population), 64 of 67 (96%) of the EpiCord‐treated ulcers healed completely within 12 weeks, compared with 26 of 40 (65%) of adequately debrided alginate‐treated ulcers, P < 0.0001. Seventy‐five subjects experienced at least one adverse event, with a total of 160 adverse events recorded. There were no adverse events related to either EpiCord or alginate dressings. These results demonstrate the safety and efficacy of EpiCord as a treatment for non‐healing DFUs.     

Effect of systemic insulin treatment on diabetic wound healing

This study investigates if different diabetic treatment regimens affect diabetic foot ulcer healing. From January 2013 to December 2014, 107 diabetic foot ulcers in 85 patients were followed until wound healing, amputation or development of a nonhealing ulcer at the last follow‐up visit. Demographic data, diabetic treatment regimens, presence of peripheral vascular disease, wound characteristics, and outcome were collected. Nonhealing wound was defined as major or minor amputation or those who did not have complete healing until the last observation. Median age was 60.0 years (range: 31.1–90.1 years) and 58 cases (68.2%) were males. Twenty‐four cases reached a complete healing (healing rate: 22.4%). The median follow‐up period in subjects with classified as having chronic wounds was 6.0 months (range: 0.7–21.8 months). Insulin treatment was a part of diabetes management in 52 (61.2%) cases. Insulin therapy significantly increased the wound healing rate (30.3% [20/66 ulcers] vs. 9.8% [4/41 ulcers]) (p = 0.013). In multivariate random‐effect logistic regression model, adjusting for age, gender, smoking status, type of diabetes, hypertension, chronic kidney disease, peripheral arterial disease, oral hypoglycemic use, wound infection, involved side, presence of Charcot's deformity, gangrene, osteomyelitis on x‐ray, and serum hemoglobin A1C levels, insulin treatment was associated with a higher chance of complete healing (beta ± SE: 15.2 ± 6.1, p = 0.013). Systemic insulin treatment can improve wound healing in diabetic ulcers after adjusting for multiple confounding covariates.     

Diabetic foot ulcers: A devastating complication of diabetes mellitus continues non-stop in spite of new medical treatment modalities

Diabetic foot ulcer is a devastating complication of diabetes mellitus and significant cause of mortality and morbidity all over the world and can be complex and costly. The development of foot ulcer in a diabetic patient has been estimated to be 19%-34% through their lifetime. The pathophysiology of diabetic foot ulcer consist of neuropathy, trauma and, in many patients, additional peripheral arterial disease. In particular, diabetic neuropathy leads to foot deformity, callus formation, and insensitivity to trauma or pressure. The standard algorithms in diabetic foot ulcer management include assessing the ulcer grade classification, surgical debridement, dressing to facilitate wound healing, off-loading, vascular assessment (status and presence of a chance for interventional vascular correction), and infection and glycemic control. Although especially surgical procedures are sometimes inevitable, they are poor predictive factors for the prognosis of diabetic foot ulcer. Different novel treatment modalities such as nonsurgical debridement agents, oxygen therapies, and negative pressure wound therapy, topical drugs, cellular bioproducts, human growth factors, energy-based therapies, and systematic therapies have been available for patients with diabetic foot ulcer. However, it is uncertain whether they are effective in terms of promoting wound healing related with a limited number of randomized controlled trials. This review aims at evaluating diabetic foot ulcer with regard to all aspects. We will also focus on conventional and novel adjunctive therapy in diabetic foot management.     

Combined use of super‐oxidised solution with negative pressure for the treatment of pressure ulcers: case report

A 61‐year‐old patient was affected by flaccid paraplegia for 20 years because of post‐traumatic medullar injury caused by an accidental fall, with stage IV sacral pressure ulcer for 3 years. The patient later developed stage IV sacral pressure ulcer. After 6 months, a new granulation tissue formation appeared in the wound and a reduction of its diameter was observed (length 20 cm, width 15 cm, depth 5 cm). We therefore treated the wound with PRP (platelet rich plasma) intra‐lesion and peri‐lesional injections. The wounds were covered with three‐dimensional polymerised hyaluronic acid medicated biologic dressing. After the surgery, a moderate reduction in diameter and the depth was observed. Super‐oxidised solution (SOS‐Dermacyn) was applied to control infection locally together with negative pressure to control the exudate and the local bacteremia, to avoid infectious complications without application of systematic antibiotic therapy.     

Safety and performance evaluation of a next‐generation antimicrobial dressing in patients with chronic venous leg ulcers

The objective of this study was to investigate the safety and performance of AQUACEL? Ag+ dressing, a wound dressing containing a combination of anti‐biofilm and antimicrobial agents, in the management of chronic wounds. Patients (n = 42) with venous leg ulcers exhibiting signs of clinical infection were treated for 4 weeks with AQUACEL? Ag+ dressing, followed by management with AQUACEL? wound dressings for 4 weeks. Wound progression, wound size, ulcer pain and clinical evolution of the wound were assessed for up to 8 weeks. Adverse events were recorded throughout the study. AQUACEL? Ag+ dressing had an acceptable safety profile, with only one patient discontinuing from the study, because of a non‐treatment‐related adverse event. After 8 weeks, substantial wound improvements were observed: 5 patients (11·9%) had healed ulcers and 32 patients (76·2%) showed improvement in ulcer condition. The mean ulcer size had reduced by 54·5%. Patients reported less pain as the study progressed. Notable improvements were observed in patients with ulcers that were considered to require treatment with systemic antibiotics or topical antimicrobials at baseline (n = 10), with a mean 70·2% reduction in wound area. These data indicate that AQUACEL? Ag+ dressing has an acceptable safety profile in the management of venous leg ulcers that may be impeded by biofilm.     

Exploring the use of an alginate dressing for diabetic foot ulcers

Few studies have investigated the use of dressings on patients with diabetic foot ulceration. This paper reports the results of a non-comparative, two-centre study investigating the performance characteristics of SeaSorb dressing in patients with this condition. This was an exploratory study to determine the potential use of this dressing, and not a large randomised control trial. All patients had diabetic foot ulceration of 1 cm or more in diameter, classified as Wagner grade I or II, with an ankle brachial pressure index of > 0.4. The investigators carried out objective assessments including photography and ulcer tracing as well as subjective assessments of exudate levels, wound bed condition, peri-ulcer skin condition, ease of application and removal of the dressing, dressing conformability, discomfort during dressing application and removal, and clinical signs of infection. Investigators recruited 41 patients in two sites (31 in site one and 10 in site two). Of these, the findings relating to 39 patients could be evaluated. The patients were treated for a maximum of six weeks or until the ulcer healed. The study found that 28.2% (11/39) of the ulcers healed within the six-week period. Overall, there was a significant reduction in mean ulcer area from 2.8 cm 2 to 1.02 cm 2 from week 0 to week six. The relative ulcer area showed a significant decrease from 100% to 33%. For patients who experienced ulcer pain (11 patients), its intensity decreased over the six weeks. Severe maceration was not reported for any patient throughout the study. Six patients required treatment for infection. A total of 12 adverse events were reported: seven mild to moderate and five severe. None were directly attributed to the study dressing.     

两种银敷料对慢性伤口愈合及渗液酸碱度影响的比较

目的比较两种银敷料辅助治疗慢性感染伤口的效果及对伤口渗液酸碱度的影响,以指导银敷料在慢性伤口治疗中的合理使用。方法将糖尿病足溃疡、压疮、下肢静脉溃疡、创伤性溃疡、烧伤残余创面5类慢性伤口患者104例随机分为A、B两组,每组52例。两组患者均按照统一方法评估、清洗和清创后,A组使用银离子藻酸盐敷料、B组使用纳米银敷料,分别接受30d的伤口局部辅助治疗。观察比较两组伤口治疗前及治疗后不同时间段的伤口愈合评分及渗液pH值。结果随着治疗时间的延长,两组伤口愈合计分和渗液pH值均较治疗前下降,A组患者伤口愈合计分显著优于B组(P0.01);两组伤口渗液pH值比较,差异无统计学意义(P0.05)。结论两种银敷料辅助治疗慢性感染伤口均能促进伤口愈合,但银离子藻酸盐敷料的效果更优;两种银敷料均能降低伤口渗液pH值且作用相当。     

Risk factors for recurrence of diabetic foot ulcers: prospective follow‐up analysis in the Eurodiale subgroup

Few studies have examined factors associated with diabetic foot ulcer (DFU) recurrence. Using data from patients enrolled in the prospective Eurodiale DFU study, we investigated the frequency of and risk factors for DFU recurrence after healing during a 3‐year follow‐up period. At our site, 93 Eurodiale‐enrolled patients had a healed DFU. Among these, 14 were not alive; of the remaining 79 patients we enrolled 73 in this study. On entry to the Eurodiale study, we assessed demographic factors (age, sex and distance from hospital); diabetes‐related factors [duration, and glycated haemoglobin (HbA1c) levels]; comorbidities (obesity, renal failure, smoking and alcohol abuse) and DFU‐related factors [peripheral arterial disease, ulcer infection, C‐reactive protein (CRP) and; foot deformities]. During the 3‐year follow‐up period, a DFU had recurred in 42 patients (57·5%). By stepwise logistic regression of findings at initial DFU presentation, the significant independent predictors for recurrence were plantar ulcer location [odds ratio (OR) 8·62, 95% confidence interval (CI) 2·2–33·2]; presence of osteomyelitis (OR 5·17, 95% CI 1·4–18·7); HbA1c > 7·5% ([DCCT], OR 4·07, 95% CI 1·1–15·6) and CRP > 5 mg/l (OR 4·27, 95% CI 1·2–15·7). In these patients with a healed DFU, the majority had a recurrence of DFU during a 3‐year follow‐up period, despite intensive foot care. The findings at diagnosis of the initial DFU were independent risk factors associated with ulcer recurrence (plantar location, bone infection, poor diabetes control and elevated CRP) and define those at high risk for recurrence, but may be amenable to targeted interventions.     

Effectiveness of the strategies of an orientation programme for the lifestyle and wound‐healing process in patients with venous ulcer: A randomised controlled trial

This study aimed to evaluate the effect of strategies of a lifestyle orientation programme on patients with venous ulcer in elastic compression therapy. This was a single‐blind, 2‐arm, randomised clinical controlled trial. The primary outcome included the reduction of the wound surface area. The secondary outcomes included the perception of pain, questionnaire of ulcer status, and quality of life. Seventy‐one patients with ulcers of venous aetiology were randomised into 2 arms: control group (CG) and intervention group (IG), with a 12‐week follow up. The CG was provided with the routine guidelines of the health services. Meanwhile, the IG was provided with lifestyle guidelines regarding the physiopathology of a venous ulcer, importance of compression therapy, physical exercises and rest in 4 face‐to‐face and 2 telephone interviews. The IG had significant improvement on the wound healing on 30, 60, and 90 days of follow up when compared with the CG (P = .0197; P = .0472; P = .0116). There were no statistical differences between groups; both had improvement in the quality of life and pain perception. Our results demonstrated that elastic compression therapy along with guidelines on lifestyle is effective adjunctive treatment to promote wound healing in patients with leg ulcers.     

Cytotoxicity of silver dressings on diabetic fibroblasts

A large number of silver‐based dressings are commonly used in the management of chronic wounds that are at risk of infection, including diabetic foot ulcers. However, there are still controversies regarding the toxicity of silver dressings on wound healing. The purpose of this study was to objectively test the cytotoxicity of silver dressings on human diabetic fibroblasts. Human diabetic fibroblasts were obtained from the foot skin of four diabetic foot ulcer patients and cultured. The effect of five silver‐containing dressing products (Aquacel Ag, Acticoat*Absorbent, Medifoam Ag, Biatain Ag and PolyMem Ag) and their comparable silver‐free dressing products on morphology, proliferation and collagen synthesis of the cultured human diabetic fibroblasts were compared in vitro. In addition, extracts of each dressing were tested in order to examine the effect of other chemical components found in the dressings on cytotoxicity. The diabetic fibroblasts cultured with each silver‐free dressing adopted the typical dendritic and fusiform shape. On the other hand, the diabetic fibroblasts did not adopt this typical morphology when treated with the different silver dressings. All silver dressings tested in the study reduced the viability of the diabetic fibroblasts and collagen synthesis by 54–70 and 48–68%, respectively, when compared to silver‐free dressings. Silver dressings significantly changed the cell morphology and decreased cell proliferation and collagen synthesis of diabetic fibroblasts. Therefore, silver dressings should be used with caution when treating diabetic wounds.     

Hyaluronic acid dressing (Healoderm) in the treatment of diabetic foot ulcer: A prospective,randomized, placebo‐controlled,single‐center study

Fast and complete healing of a diabetic foot ulcer (DFU) is challenging due to the hostile wound healing environment of the diabetic patients. As a part of a multimodal treatment approach, advanced dressing material using hyaluronic acid (HA) has been found to be effective. However, previous studies have used HA with additional biologics, which interferes in determining the true clinical effect of HA in DFU. To examine the sole effectiveness of HA in DFU treatment, a prospective, randomized, placebo‐controlled, single‐center study was conducted using an HA dressing without additional substances. Thus, 34 patients who met the inclusion criteria were randomized into two groups (the study group: HA dressing material; the control group: conventional dressing material). During the 12‐week study period, complete ulcer healing rate was evaluated as a primary endpoint. Additionally, healing velocity and the mean duration for achieving a 50% ulcer size reduction was compared between the two groups as a secondary endpoint. At the end of the study, the study group presented a significantly higher complete healing rate as compared to that in the control group [84.6% (11/13), 41.6% (5/12), respectively, P = 0.041]. Additionally, faster ulcer healing velocity and shorter mean duration for achieving a 50% ulcer size reduction were observed in the study group (P = 0.022 and 0.004, respectively). The Kaplan‐Meier survival analysis for the median time for 50% ulcer healing rate also showed a significantly shorter duration in the study group (21 days vs. 39 days, P = 0.0127). Finally, there were no adverse events related to the dressing materials used in the study. As a major component of the extracellular matrix, this study supports the safety and efficacy of a pure HA dressing without additional substances in treating DFU.     

An open multicenter comparative randomized clinical study on chitosan

Chitosan, a natural polysaccharide derivate from chitin, offers a promising alternative biomaterial for use in wound dressings. In this work, the safety and efficacy of a next‐generation KA01 chitosan wound dressing in facilitating the healing of nonhealing chronic wounds was studied. This open multicenter comparative prospective randomized clinical study was conducted at three medical centers in China. A total of 90 patients (45 in test group and 45 in control group) with unhealed chronic wounds including pressure ulcers, vascular ulcers, diabetic foot ulcers, and wounds with minor infections, or at risk of infection, were treated with the next generation chitosan wound dressing as the test article or traditional vaseline gauze as a control. Baseline assessments were undertaken with the primary end point being wound area reduction. The secondary end points included pain reduction (using the NRS11 pain scale) at dressing change, wound exudate levels, wound depth and duration of the treatment. After 4 weeks treatment, the wound area reduction was significantly greater in the test group (65.97 ± 4.48%) than the control group (39.95 ± 4.48%). The average pain level in the test group was 1.12 ± 0.23 and 2.30 ± 0.23 in the control group. The wound depth was also lower in the test group 0.30 ± 0.48 cm than the control group 0.54 ± 0.86 cm. The level of exudate fell and the dressing could be removed integrally in both the test and control groups. The mean duration of the test group was 27.31 ± 5.37 days and control group 27.09 ± 6.44 days. No adverse events were reported in either group. In conclusion this open multicenter comparative prospective randomized clinical study has provided compelling evidence that the next generation chitosan wound dressing can enhance wound progression towards healing by facilitating wound reepithelialization and reducing the patients pain level. Furthermore the dressing was shown to be clinically safe and effective in the management of chronic wounds.     

Outcomes of allogenic acellular matrix therapy in treatment of diabetic foot wounds: an initial experience

The purpose of this study was to evaluate outcomes of persons with UT grade 2A neuropathic diabetic foot wounds treated with an acellular matrix. Data were abstracted for 17 consecutive patients with diabetes--76.5% males, aged 61.5 +/- 8.5 years with a mean glycated haemoglobin of 9.2 +/- 2.2% presenting for care at a large, multidisciplinary wound care centre. All patients received surgical debridement for their diabetic foot wounds and were placed on therapy consisting of a single application of an acellular matrix graft (GraftJacket; Wright Medical Technologies, Arlington, TN, USA) with dressing changes taking place weekly. Outcomes evaluated included time to complete wound closure and proportion of patients achieving wound closure in 20 weeks. Acellular matrix therapy was used as initial therapy and was sutured or stapled in place under a silicone-based non adherent dressing. Therapy was then followed by a moisture-retentive dressing until complete epithelialisation. In total, 82.4% of wounds measuring a mean 4.6 +/- 3.2 cm(2) healed in the 20-week evaluation period. For those that healed in this period, healing took place in a mean 8.9 +/- 2.7 weeks. We conclude that a regimen consisting of moist wound healing using an acellular matrix dressing may be a useful adjunct to appropriate diabetic foot ulcer care for deep, non-infected, non-ischaemic wounds. We await the completion of further trials in this area to confirm or refute this initial assessment.     

CT10MANAGING DEEP STERNAL WOUND INFECTIONS WITH VACUUM ASSISTED CLOSURE

Purpose Deep sternal wound infection is a rare but serious complication of cardiac surgery. Currently there is no consensus on the optimal management. Vacuum Assisted Closure (V.A.C.) has been increasingly used to facilitate wound healing. We aim to review the management of deep sternal wound infections using V.A.C. dressing at our hospital. Methodology 31 consecutive deep sternal wound infections over a five year period were reviewed. V.A.C. dressing was used either as a stand alone therapy or as an intermediate therapy to late sternal reconstruction. Results Deep sternal wound infections were diagnosed on average 13 days from initial surgery. 26 (84%) patients were treated with V.A.C. dressing. Of these, 17 (65%) had stand alone V.A.C. therapy and 9 were followed by sternal reconstruction. The average duration of V.A.C dressing in the two groups were 21 and 13 days respectively. 7 patients died, 6 in the stand alone V.A.C. group and 1 in the intermediate V.A.C. group. The length of hospital stay was similar in both groups (41 vs. 45 days). Median follow up was 17 months. No late relapse was found in the stand alone group. In the intermediate therapy group, 2 patients had chronic wound sinuses and one patient had a wound collection. Conclusion V.A.C. dressing may be used both as a stand alone and as an intermediate therapy for deep sternal wound infection. Reconstructive surgery may be avoided in a significant proportion of patients. No late relapse has been associated with V.A.C. use.     

Impact of gauze‐based NPWT on the patient and nursing experience in the treatment of challenging wounds

Negative pressure wound therapy is widely used in the treatment of hard‐to‐heal wounds; however, pain during dressing changes, which is often associated with pain on the commencement and cessation of pressure application and because of in‐growth of new granulation tissue into interstices of foam dressings, is often experienced. Anecdotal reports have suggested that choice of gauze as the negative pressure wound therapy dressing may reduce the pain associated with dressing changes. A prospective, multi‐center, non‐comparative clinical investigation was carried out using gauze‐based negative pressure wound therapy in chronic and acute wounds. Over 152 patients were evaluated. Median duration of therapy was 18 days with 91% of patients progressing towards healing at the end of therapy. Wound pain and odour were significantly reduced (P < 0·001) over the course of therapy. Wound pain during dressing changes was reported to be absent in 80% of dressing removals. No damage to the wound bed following dressing removal was observed in 96% of dressing changes. Dressing applications were considered easy in 79% of assessments and took a median of 20 min to complete. In patients susceptible to pain, gauze‐based negative pressure therapy may be a viable option to maximise patient comfort.     

A retrospective study of cryopreserved umbilical cord as an adjunctive therapy to promote the healing of chronic,complex foot ulcers with underlying osteomyelitis

Complex lower extremity ulcers with exposed bone, tendon, muscle, and/or joint capsule as well as multiple comorbidities including diabetes, ischemia, and underlying osteomyelitis are difficult to heal and associated with high morbidity and mortality and high rates of amputation. A retrospective review was performed to assess healing of 31 patients presenting with 33 complex foot ulcers with a confirmed histopathological diagnosis of osteomyelitis treated by the same surgeon at a single wound care center by the following treatment regimen: sharp debridement, resection of infected bone when necessary, open cortex, antibiotics, and application of cryopreserved umbilical cord (cUC). The average ulcer size was 15.6 ± 17.7 cm² (0.4–73.95 cm²). Overall, 26 out of the 33 wounds achieved complete closure (78.8%). Five patients were lost to follow‐up and one patient expired during the course of treatment, not believed to be treatment related. Of the remaining 27 wounds in patients not lost to follow‐up, 26 achieved complete healing with an average time to healing of 16 weeks and an average of 1.24 applications of cUC. The results suggest that cUC used as an adjunctive tissue therapy in conjunction with surgical debridement, resection of infected bone, open cortex, and antibiotic treatment may be an effective overall treatment strategy to promote wound healing of complex foot ulcers associated with osteomyelitis. The preliminary results are encouraging and warrant further randomized control studies to determine whether cUC might help address such an unmet medical need.     

A systematic review of low‐level light therapy for treatment of diabetic foot ulcer

Diabetes mellitus (DM) is a significant international health concern affecting more than 387 million individuals. A diabetic person has a 25% lifetime risk of developing a diabetic foot ulcer (DFU), leading to limb amputation in up to one in six DFU patients. Low‐level light therapy (LLLT) uses low‐power lasers or light‐emitting diodes to alter cellular function and molecular pathways, and may be a promising treatment for DFU. The goal of this systematic review is to examine whether the clinical use of LLLT is effective in the healing of DFU at 12 and 20 weeks in comparison with the standard of care, and to provide evidence‐based recommendation and future clinical guidelines for the treatment of DFU using LLLT. On September 30, 2015, we searched PubMed, EMBASE, CINAHL, and Web of Science databases using the following terms: “diabetic foot” AND “low level light therapy,” OR “light emitting diode,” OR “phototherapy,” OR “laser.” The relevant articles that met the following criteria were selected for inclusion: randomized control trials (RCTs) that investigated the use of LLLT for treatment of DFU. Four RCTs involving 131 participants were suitable for inclusion based upon our criteria. The clinical trials used sham irriadiation, low dose, or nontherapeutic LLLT as placebo or control in comparison to LLLT. The endpoints included ulcer size and time to complete healing with follow‐up ranging from 2 to 16 weeks. Each article was assigned a level of evidence (LOE) and graded according to the Oxford Center for Evidence‐based Medicine Levels of Evidence Grades of Recommendation criteria. Limitations of reviewed RCTs include a small sample size (N < 100), unclear allocation concealment, lack of screening phase to exclude rapid healers, unclear inclusion/exclusion criteria, short (<30 days) follow‐up period, and unclear treatment settings (wavelength and treatment time). However, all reviewed RCTs demonstrated therapeutic outcomes with no adverse events using LLLT for treatment of DFU. This systematic review reports that LLLT has significant potential to become a portable, minimally invasive, easy‐to‐use, and cost effective modality for treatment of DFU. To enthusiastically recommend LLLT for treatment of DFU, additional studies with comparable laser parameters, screening period to exclude rapid healers, larger sample sizes and longer follow‐up periods are required. We envision future stringent RCTs may validate LLLT for treatment of DFU. Systematic review registration number: PROSPERO CRD42015029825.     

Ergebnisse der Implementierung eines Wundbehandlungsstandards im Haus der Maximalversorgung

In Germany, over four million patients with chronic wounds are treated annually, with annual medical costs amounting to over 4 billion euro. A substantial proportion of these costs involve the inpatient treatment for crural ulcer, the causes of diabetic foot syndrome and decubitus ulcer. Modern, stage-appropriate wound care can reduce the costs of wound therapy by reducing the changing intervals for wound dressing and faster healing of the wound. Despite these advantages, modern wound care with hydroactive dressings is not established throughout Germany, and, in particular, is still too rarely used in the outpatient sector of modern wound therapy. The introduction of interdisciplinary treatment standards in a maximum care hospital leads to a quality increase in wound therapy by the consistent application of modern, stage-appropriate treatment. Unfounded therapy changes, in particular after transfers into another department, can be avoided. Apart from the medical advantages, logistic and legal aspects also speak for the introduction of a wound treatment standard.