Efficacy and safety of becaplermin (recombinant human platelet-derived growth factor-BB) in patients with nonhealing, lower extremity diabetic ulcers: a combined analysis of four randomized studies

The results of a combined analysis and separate analyses of four multicenter, randomized, parallel group studies that evaluated the effects of once-daily topical administration of becaplermin gel for the treatment of chronic, full thickness, lower extremity diabetic ulcers are presented. The four studies included a total of 922 patients with nonhealing lower extremity diabetic ulcers of at least 8 weeks' duration. Following initial complete sharp debridement of the ulcer, patients were randomized to receive a standardized regimen of good ulcer care alone, good ulcer care plus placebo gel, or good ulcer care plus becaplermin gel-30 microg/g, or good ulcer care plus becaplermin gel-100 microg/g, with various combinations of regimens used in the four studies. Safety was assessed by monitoring adverse events and by clinical laboratory evaluations. Meta-analytic statistical techniques were used in the combined analysis to establish homogeneity of treatment comparisons across studies. Based on an analysis of patients with baseline ulcer area common to all trials (相似文献   

Becaplermin gel in the treatment of pressure ulcers: a phase II randomized, double-blind, placebo-controlled study

Pressure ulcers are associated with significant rates of morbidity and mortality, particularly in the geriatric and spinal cord-injured populations. Newer pharmacologically active therapies include the use of topically applied recombinant human platelet-derived growth factor-BB (becaplermin), the active ingredient in REGRANEX) (becaplermin) Gel 0.01%, which has been approved in the United States for treatment of lower extremity diabetic neuropathic ulcers that extend into the subcutaneous tissue or beyond and have an adequate blood supply. In this study, the efficacy of becaplermin gel in the treatment of chronic full thickness pressure ulcers was compared with that of placebo gel. A total of 124 adults (>/= 18 years of age) with pressure ulcers were assigned randomly to receive topical treatment with becaplermin gel 100 microg/g (n = 31) or 300 microg/g (n = 32) once daily alternated with placebo gel every 12 hours, becaplermin gel 100 microg/g twice daily (n = 30), or placebo (sodium carboxymethylcellulose) gel (n = 31) twice daily until complete healing was achieved or for 16 weeks. All treatment groups received a standardized regimen of good wound care throughout the study period. Study endpoints were the incidence of complete healing, the incidence of >/= 90% healing, and the relative ulcer volume at endpoint (endpoint/baseline). Once-daily treatment of chronic pressure ulcers with becaplermin gel 100 microg/g or 300 microg/g significantly increased the incidences of complete and >/= 90% healing and significantly reduced the median relative ulcer volume at endpoint compared with that of placebo gel (p < 0.025 for all comparisons). Becaplermin gel 300 microg/g did not result in a significantly greater incidence of healing than that observed with 100 microg/g. Treatment with becaplermin gel was generally well tolerated and the incidence of adverse events was similar among treatment groups. In conclusion, once-daily application of becaplermin gel is efficacious in the treatment of chronic full thickness pressure ulcers.     

Use of topical recombinant human platelet-derived growth factor-BB (becaplermin) in healing of chronic mixed arteriovenous lower extremity diabetic ulcers.

Lower extremity ulcers cause significant morbidity and mortality in patients with diabetes. The primary factors that contribute to the development of this type of ulcer are peripheral neuropathy and peripheral vascular disease, which are often accompanied by infection. Lower extremity diabetic ulcers are chronic and difficult to treat, in part due to underlying pathologic conditions in individuals with diabetes that can contribute to impaired wound healing. This article reports the author's experience with treatment of chronic lower extremity ulcers of mixed etiologies with recombinant human platelet-derived growth factor--BB [rhPDGF-BB, REGRANEX (becaplermin) Gel 0.01%] in a patient with multiple risk factors including long-standing insulin-dependent type 2 diabetes.     

Treatment Options for Diabetic Neuropathic Foot Ulcers: A Cost-Effectiveness Analysis

BACKGROUND: Diabetic foot ulcers are a common problem and result in more than 85,000 lower extremity amputations each year in the United States. Studies have suggested that between 25% and 50% of costs related to inpatient diabetes care may be directly attributable to the diabetic foot. Novel treatments for these wounds, while expensive, have been reported to improve healing rates, although no formal cost effectiveness analyses have been performed in order to address the cost effectiveness of a given therapy. OBJECTIVE: To estimate the cost effectiveness of common treatment strategies for diabetic neuropathic foot ulcers. METHODS: Four main options are available for the treatment of diabetic foot ulcers: (1) standard care (SC), (2) standard treatment in a specialized wound care center (WCC), (3) treatment with becaplermin, (4) or treatment with platelet releasate (PR). We utilized effectiveness data from published clinical trials, meta-analyses, and a database that includes data on 26,599 patients with these wounds. Effectiveness was assessed as a percentage of ulcers healed at 20 and 32 weeks. RESULTS: Baseline effectiveness (with 95% confidence intervals) for SC, becaplermin, PR, and WCC care were 30.9% (26.6, 35.1), 43.0% (37.3, 48.7), 36.8% (35.4, 38.2), and 35.6% (34.8, 36.4), respectively. Cost:effectiveness ratios for PR versus SC and becaplermin versus SC were 414.40 and 36.59, respectively. Therefore the incremental cost of increasing the odds of healing by 1% over standard therapy was $414.40 for PR and $36.59 for becaplermin. CONCLUSIONS: PR, becaplermin, and WCC care all provided improved healing rates over standard care, and becaplermin was less expensive and more effective than PR after 20 weeks of care.     

Health-related quality of life in diabetic patients with foot ulcers: literature review.

Foot ulcers are a common, serious, and costly complication of diabetes, preceding 84% of lower extremity amputations in diabetic patients and increasing the risk of death by 2.4-fold over diabetic patients without ulcers. Health-related quality of life (HRQOL) is worse among individuals with diabetes than individuals without diabetes, and complications of diabetes, including foot ulcers, have a major negative effect on HRQOL. Diabetic foot ulcers are associated with reduced mobility and deficits related to activities of daily living that adversely affect HRQOL. Qualitative studies have confirmed clinical observations that diabetic foot ulcers have a huge negative psychological and social effect, including reduction in social activities, increased family tensions for patients and their caregivers (spouses or partners), limited employment, and financial hardship. Quantitative studies confirm the findings of qualitative studies that diabetic foot ulcers exert a negative effect on physical functioning, psychological status, and social situation. Recent advances include the development and validation of disease-specific HRQOL surveys for diabetic patients with foot ulcers. Disease-specific surveys may improve the evaluation of HRQOL as a function of ulcer healing, the effect of different treatment methods on HRQOL, and the relationship between treatment-specific HRQOL, patient compliance, and treatment efficacy.     

Recurrence rate of diabetic neurotrophic foot ulcers healed using topical application of growth factors released from platelets

The purpose of this study was to determine the recurrence rate of diabetic neurotrophic foot ulcers that had healed in a treatment protocol using topically applied growth factors released from platelets. Thirty-six patients with diabetic neurotrophic foot ulcers were entered into a randomized prospective double-blind 20-week trial of topically applied platelet growth factors or buffered saline dressings. Ulcers had been present for 15.5 months (mean, range 2 to 60 months). Sixteen patients (44%) healed and were followed up for as many as 30 months to determine the rate of ulcer recurrence. Eleven patients (68.8%) had ulcers that recurred, including 10 treated with platelet growth factors and one treated with buffered saline solution. These ulcers had been present for 20 months (range 5 to 60 months) before healing. Average time to ulcer recurrence was 2.2 months (range 0.25 to 7 months). Five ulcers (31.2%) remained healed, including four treated with platelet growth factors and one treated with buffered saline solution. These healed, nonrecurring ulcers had been present for 5 months (range 2 to 6 months) before healing. Average follow up was 25 months (range 24 to 30 months). Ulcers were more likely to recur if they had been present longer before healing. If patients were not compliant in wearing footwear to protect the healed ulcer, the ulcers were prone to early recurrence. These data indicate that ulcers healed by using growth factors in the form of a platelet growth factors did not have more durable skin over the ulcer and were prone to early ulcer recurrence.     

Cost-effective management of recalcitrant diabetic foot ulcers

The worldwide increase in prevalence of type 2 diabetes has resulted in a parallel increase in diabetic foot ulcers--a pervasive and significant problem associated with this disease [2]. Currently, an estimated 10.3 million people have been diagnosed with diabetes, while an additional estimated 5.4 million people with diabetes remain undiagnosed, representing a sixfold increase in the incidence of diabetes over the past four decades [9]. Approximately 15% (more than 2 million individuals, based on these estimates) of all people with diabetes will develop a lower-extremity ulcer during the course of the disease [10-12]. While most of these ulcers can be treated successfully on an outpatient basis, some will persist and become infected. Ultimately, between 14% and 20% of patients with lower-extremity diabetic ulcers will require amputation of the affected limb [13-15]. Diabetic foot ulcers can result in staggering financial burdens for both the healthcare system and the patient. For example, analysis of the 1995 Medicare claims revealed that lower-extremity ulcer care accounted for $1.45 billion in Medicare costs and contributed substantially to the high cost of care for diabetics, compared with Medicare costs for the general population [5]. Therapies that promote rapid and complete healing and reduce the need for expensive surgical procedures would impact these costs substantially. Results of this analysis suggest that becaplermin may ultimately be more cost-effective for the treatment of chronic diabetic foot ulcers than other treatment modalities, despite its higher initial dollar cost. This finding may be attributed to a combination of factors. First, expenses incurred in more prolonged treatment, such as office visits and the need for additional dressings, can be avoided when healing completes in a shorter period. Second, rapid and complete ulcer healing may reduce the incidence of significant morbidities (such as amputation or infection) and premature mortality; consequently, the financial burden associated with these complications would be reduced. Finally, the value of improved quality of life in patients with healed ulcers and the reduction in financial burden for patients who return to work cannot be ignored. These promising results warrant further investigation in larger controlled clinical studies to define more clearly the cost-effectiveness of becaplermin in this patient population.     

Diabetic heel ulcer in the Sudan: determinants of outcome

Heel ulceration, on average, costs 1.5 times more than metatarsal ulceration. The aim of this study was to analyze the determinant factors of healing in diabetic patients with heel ulcers and the late outcomes at Jabir Abu Eliz Diabetic Centre Khartoum, Khartoum, Sudan. Data were collected prospectively for 96 of 100 diabetic patients presenting with heel ulcers at the Jabir Abu Eliz Diabetic Centre Khartoum from May 2003 to January 2005. Late outcome was assessed 3 years later (February 2008). Heeling was achieved in one half of the patients (n = 48). In the remaining 48 patients, 22 ended with major lower extremity amputation and 22 were still receiving wound care. A total of 8 patients died, 4 in each group, the healed and unhealed. The most significant determinants of healing using a logistic multivariate regression model, 95% confidence intervals, and odds ratios included a shorter duration of diabetes (p < .009), adequate lower limb perfusion (p < .043), and a superficial foot ulcer (p < .012). Three years later, of the 88 patients who could be traced, 78 were alive and 59 had healed ulcers (7 had died of unrelated causes and 3 of diabetic-related complications), and no additional lower extremity amputation was recorded. Mortality in the series was 18 patients, of whom 14 had undergone a previous lower extremity amputation. Superficial heel ulcers in diabetic patients with a short history of diabetes and with good limb circulation are more likely to heal within an average duration of 25 weeks. At 3 years of follow-up, 75% showed a favorable outcome for ulcer healing, and 22 patients underwent lower extremity amputation (25%), of whom 14 were dead within 3 years.     

Total-contact casting as an adjunct to promote healing of pressure ulcers in amputees

Partial foot amputations have become increasingly prevalent among long-lived diabetic patients. These patients have lower extremity neuropathy and are prone to ulceration at their amputation site. These ulcers are difficult to heal, and they place a significant financial and resource burden on the healthcare system. We examined the efficacy of total-contact casts (TCC) in diabetic amputees with nonhealing partial foot amputation site neuropathic ulcers. Data were collected retrospectively on all patients with amputations who were treated with a total-contact cast between December 2000 and December 2003. Seventeen patients (13 men, 4 women) with amputation site ulceration were identified. All patients were diagnosed with neuropathy secondary to diabetes and none had wound healing compromised by ischemia. The initial ulcer averaged 1,169 mm(2) with a depth of 2.77 mm. Patients were treated with an average of 7.9 cast applications over 8.4 weeks; 47% (8/17) of ulcers healed, but 29% (5/17) of patients were unable to complete their recommended treatment course secondary to complications from the TCC. Of the patients who were able to complete their treatment course, the healing rate was 66.7% (8/12). The recurrence rate for healed ulcers was 63% (5/8). Partial foot amputations with neuropathic ulcers present a very difficult problem to the vascular surgeon. Patient compliance and underlying medical comorbidities limit the success rate. In patients who can complete a TCC treatment course, good short term results can be expected. However, recurrence rates are high following discontinuation of mechanical TCC off-loading.     

鹿茸多肽-壳聚糖-蜂蜜混悬剂对猪皮肤褥疮的促愈合作用

[目的]探讨中成药制剂鹿茸多肽-壳聚糖-蜂蜜混悬剂对褥疮愈合的影响。[方法]采用猪压疮为褥疮模型。以蜂蜜为溶剂性载体,将鹿茸多肽和壳聚糖以不同比例混悬于蜂蜜中,制成混悬剂,敷于创面,每天1次,连续7 d,以后隔日换药一次。观察创面愈合情况,计算创面面积。观察创面病理组织学改变。[结果]鹿茸多肽-壳聚糖-蜂蜜混悬剂中鹿茸多肽与壳聚糖4∶1组创面渗出少,肉芽组织生长快,结痂脱落早而完全。病理结果显示鹿茸多肽与壳聚糖4∶1组无坏死组织,上皮化明显,炎症细胞少,无水肿,新生血管数多。[结论]鹿茸多肽-壳聚糖-蜂蜜混悬剂在褥疮的修复过程中起到明显的促进作用,其可能的机制有待于进一步研究。     

Endovenous Ablation for the Treatment of Chronic Venous Insufficiency and Venous Ulcerations

Objective  

Conventional treatment of chronic venous disease with ulceration is layered compression dressings. Saphenous vein stripping is reserved for recurrent or nonhealing ulcers. This study examines outcomes of aggressive endovenous therapy in promoting ulcer healing and/or preventing ulcer recurrence. The role of additional perforator vein ablation also is analyzed.     

Talactoferrin alfa, a recombinant human lactoferrin promotes healing of diabetic neuropathic ulcers: a phase 1/2 clinical study

BACKGROUND: Talactoferrin alfa, a recombinant form of human lactoferrin, is a novel immunomodulatory protein with demonstrated ulcer healing properties in animal models. METHODS: A phase 1/2 clinical study was conducted at 7 clinical sites to determine if talactoferrin can improve wound healing in diabetic patients with foot ulceration. Fifty-five patients with diabetic neuropathic foot ulcers participated in this 2-phase study. In phase 1, groups of 3 patients each received open-label 1%, 2.5%, or 8.5% talactoferrin gel twice daily, in a sequential design, to their ulcer for 30 days. No drug-related adverse events were found at any dose level. Phase 2 was a randomized, placebo-controlled, single-blind study of 2.5% and 8.5% gels, with patients equally divided between the 3 groups. In combination with good wound care, treatment was administered topically twice daily to the ulcers for 12 weeks. The primary endpoint was the incidence of > or = 75% healing (relative to baseline size). RESULTS: The study, which in phase 2 was powered to detect a difference between the placebo and combined talactoferrin arms with P < .1, met the primary objective. The groups receiving the 2.5% (n = 15) and 8.5% (n = 15) gels had twice the incidence of > or = 75% reduction in ulcer size compared with the placebo group (n = 16): 47%, 53%, and 25%, respectively. On an intent-to-treat basis, the combination of the 2 active groups when compared with the placebo group showed a strong trend toward statistical significance (P = .09). There were no talactoferrin-related adverse events or laboratory abnormalities. CONCLUSIONS: Topical talactoferrin appears to be safe and well tolerated and improves healing of diabetic neuropathic ulcers.     

Leg ulcer: proposal of a new method for comparing different wound dressings

The study proposes a new method for measuring peripheral trophic lesions (leg ulcers) of the same patient medicated with different type of dressing, avoiding errors of evaluation due to comparing different patients who generally present different concomitant pathologies and aetiologies wigh are hard to compare. We studied the wound care of 11 patients with leg ulcers. Half of the ulceration was treated with a traditional dressing (group A) and the other half with a more advanced type of dressing (group B). We first photographed the ulceration at a predefined distance an then the ulcer was separated in two identical parts and measured with millimetre paper. The limits and sides of each part were marked with a indelible marker pencil. The dressings were changed at regular interval and the ulcers were re-measured and photographed every week from the same distance. We examined 19 ulcers of the 11 patients (7 men, 4 women; mean age: 71 years). Although wound healing appeared to be faster in group B, the difference was not statistically significant (p = 0,246), but the aim of the study was not to explore the difference or otherwise in healing rate between two dressings. The study confirms that this method enables the physician to compare two different wound care dressings on the same ulcer. Interpatient variability is thus avoided by applying the dressings to the same ulcer. Changes in ulcer size are easily monitored and the statistical analysis of the areas compared allows objective assessment of the wound treatments, avoiding the common bias due to comparing different ulcers on different patients with different underlying pathologies.     

Evidence‐based chronic ulcer care and lower limb outcomes among Pacific Northwest veterans

Evidence‐based ulcer care guidelines detail optimal components of care for treatment of ulcers of different etiologies. We investigated the impact of providing specific evidence‐based ulcer treatment components on healing outcomes for lower limb ulcers (LLU) among veterans in the Pacific Northwest. Components of evidence‐based ulcer care for venous, arterial, diabetic foot ulcers/neuropathic ulcers were abstracted from medical records. The outcome was ulcer healing. Our analysis assessed the relationship between evidence‐based ulcer care by etiology, components of care provided, and healing, while accounting for veteran characteristics. A minority of veterans in all three ulcer‐etiology groups received the recommended components of evidence‐based care in at least 80% of visits. The likelihood of healing improved when assessment for edema and infection were performed on at least 80% of visits (hazard ratio [HR] = 3.20, p = 0.009 and HR = 3.54, p = 0.006, respectively) in patients with venous ulcers. There was no significant association between frequency of care components provided and healing among patients with arterial ulcers. Among patients with diabetic/neuropathic ulcers, the chance of healing increased 2.5‐fold when debridement was performed at 80% of visits (p = 0.03), and doubled when ischemia was assessed at the first visit (p = 0.045). Veterans in the Pacific Northwest did not uniformly receive evidence‐based ulcer care. Not all evidence‐based ulcer care components were significantly associated with healing. At a minimum, clinicians need to address components of ulcer care associated with improved ulcer healing.     

Electrical nerve stimulation improves healing of diabetic ulcers.

A controlled study of the effects of electrical nerve stimulation (ENS) was performed in conjunction with a standard treatment for healing chronic diabetic ulcers on 64 patients divided randomly into two groups. All patients received standard treatment (paste-impregnated bandage and a self-adhesive elastic bandage) plus placebo ENS or ENS (alternating constant current; frequency, 80 Hz; pulse width, 1 msec; intensity-evoking strong paresthesias) for 20 minutes twice daily for 12 weeks. Comparison of percentages of healed ulcer area and the number of healed ulcers was made after 2, 4, 6, 8, and 12 weeks. There were significant differences (p < 0.05) in both ulcer area and healed ulcers in the ENS group compared with the placebo group after 12 weeks of treatment. The results of the present study support the use of ENS in diabetic ulcers. ENS is easy to apply and can be used by the patient at home following instructions from a medical doctor or a therapist experienced in electrical stimulation and the treatment of ulcers. Additional studies are needed to identify the mechanisms involved in the promotion of ulcer healing with electrical stimulation and to determine the stimulus variables that most efficaciously accelerate tissue repair.     

Clinical outcomes of wide postsurgical lesions in the infected diabetic foot managed with 2 different local treatment regimes compared using a quasi-experimental study design: a preliminary communication

The safety and efficacy of a novel superoxidized solution (Dermacyn Wound Care [DWC], Oculus Innovative Sciences, Petaluma, Calif) was evaluated for the treatment of wide postsurgical infected ulcers of the diabetic foot. A group (group A, n = 18) of patients with diabetes mellitus who had postsurgical lesions > 5 cm(2) without ischemia or infection were recruited consecutively and treated with DWC-saturated dressings. These dressings were renewed once daily and were compared with a group of patients that had been previously treated with diluted povidone iodine (group B, n = 15) using a quasi-experimental study design. Both sets of patients also received standard systemic antibiotic therapy, as per the practice in this center, and local surgical debridement. Patients had weekly assessments until wounds had re-epithelialized completely. Patients in group A had statistically significant shorter healing time and duration of antibiotic therapy and a higher healing rate at 6 months compared with those in group B (p < .01). Recurrence of infection, requirement for debridement procedures, and requirement for minor amputations were significantly less frequent during follow-up in group A patients (p < .05) when compared with those in group B. These preliminary data suggest that DWC used as a wound dressing together with other local and systemic therapies may have a role in reducing healing time as well as complications in patients with diabetes who have postsurgical lesions of the diabetic foot. These data propose the need for a robust controlled study of DWC-saturated dressings to explore its full potential.     

Autologous platelet‐rich gel for treatment of diabetic chronic refractory cutaneous ulcers: A prospective,randomized clinical trial

The purpose of the study is to examine the safety and effectiveness of topical autologous platelet‐rich gel (APG) application on facilitating the healing of diabetic chronic refractory cutaneous ulcers. The study was designed as a prospective, randomized controlled trial between January 1, 2007 and December 31, 2011. Eligible inpatients at the Diabetic Foot Care Center of West China Hospital, Sichuan University (China) were randomly prescribed with a 12‐week standard treatment of ulcers (the control group) or standard treatment plus topical application APG (the APG group). The wound healing grades (primary endpoint), time to complete healing, and healing velocity within 12 weeks were monitored as short‐term effectiveness measurements, while side effects were documented safety endpoints. The rates of survival and recurrence within the follow up were recorded as long‐term effectiveness endpoints. Analysis on total diabetic ulcers (DUs) (n = 117) and subgroup analysis on diabetic foot ulcers (DFUs) (n = 103) were both conducted. Standard treatment plus APG treatment was statistically more effective than standard treatment (p < 0.05 in both total DUs and subgroup of DFUs). The subjects defined as healing grade 1 were 50/59 (84.8%) in total DUs and 41/48 (85.4%) in DFUs in the APG group compared with 40/58 (69.0%) and 37/55 (67.3%) in the control group from intent to treat population. The Kaplan‐Meier time‐to‐healing were significantly different between the two groups (p < 0.05 in both total DUs and subgroup of DFUs). No side effects were identified after topical APG application. The long‐term survival and recurrence rates were comparative between groups (p > 0.05). This study shows that topical APG application plus standard treatment is safe and quite effective on diabetic chronic refractory cutaneous ulcers, compared with standard treatment.     

NorLeu3‐A(1–7) stimulation of diabetic foot ulcer healing: Results of a randomized,parallel‐group,double‐blind,placebo‐controlled phase 2 clinical trial

This randomized, double‐blind, placebo‐controlled Phase 2 clinical trial explored NorLeu³‐A(1–7) (DSC127) safety and healing efficacy in diabetic foot ulcers. Patients with chronic, noninfected, neuropathic, or neuroischemic plantar Wagner Grade 1 or 2 foot ulcers (n = 172) were screened for nonhealing. Subjects were randomized to receive 4 weeks’ once‐daily topical treatment with 0.03% DSC127 (n = 26), 0.01% DSC127 (n = 27), or Placebo (n = 24), followed by 20 weeks’ standard of care. DSC127 was assessed for safety (including laboratory values and adverse events), primary efficacy (% ulcers completely epithelialized at Week 12), and durability of effect. Baseline, demography, and safety parameters were compared between intent‐to‐treat groups and were comparable. Dose‐response curves for DSC127 effect on % area reduction from baseline at Week 12 (40% placebo; 67% 0.01% DSC127; 80% 0.03% DSC127) and 24 (23% placebo; 53% 0.01% DSC127; 95% 0.03% DSC127) followed a log‐linear pattern for both intent‐to‐treat and per‐protocol populations. Covariate analysis compared reduction in ulcer area, depth, and volume from baseline; reductions in the 0.03% DSC127 group were greater at Weeks 12 and 24. Placebo‐treated ulcers healed in a median 22 weeks vs. 8.5 weeks for 0.03%DSC127 (p = 0.04). This study provides preliminary evidence that DSC127 is safe and effective in accelerating the healing of diabetic foot ulcers.     

The diabetic foot: perspectives from Chennai, South India

Foot ulcers are a significant complication of diabetes mellitus and often precede lower extremity amputation. The most frequent underlying etiologies are neuropathy, trauma, deformity, high plantar pressures, and peripheral arterial disease. Loss of protective sensation is the primary factor in foot ulceration in diabetics. Mechanical stresses resulting from joint deformity, limited joint mobility, and poor foot care/footwear are important in the causal pathway of both neuropathic and ischemic ulcers. It was shown that the recurrence of foot infection was common among Indian diabetic patients (52%). A lesser prevalence of peripheral vascular disease (13%) among Indians was noted when compared with those in Western countries (48%). Smoking increases the risk by reducing blood circulation in the legs and reducing sensation in the feet. Prompt and aggressive treatment of diabetic foot ulcers can often prevent exacerbation of the problem and eliminate the potential for amputation. The aim of the therapy should be early intervention to allow prompt healing of the lesion and prevent recurrence once it is healed. Multidisciplinary management programs that focus on prevention, education, regular foot examinations, aggressive intervention, and optimal use of therapeutic footwear have demonstrated significant reductions in the history of lower extremity amputations.     

Efficacy and cost‐effectiveness of octenidine wound gel in the treatment of chronic venous leg ulcers in comparison to modern wound dressings

The aim of this study was to determine the efficacy, safety and cost‐effectiveness of an octenidine‐based wound gel in the treatment of chronic venous leg ulcers. For this purpose, 49 wounds were treated with either modern wound‐phase‐adapted dressings alone (treatment arm 1; n = 17), octenidine wound gel plus modern wound‐phase‐adapted dressings (treatment arm 2; n = 17) or octenidine wound gel alone (treatment arm 3; n = 15). During the study period of 42 days with dressing changes every 3–5 days, wound healing characteristics and treatment costs of different dressings were analysed. Wound size reduction was significantly better (P = 0·028) in both octenidine wound gel treatment arms compared to modern dressings alone with total reductions of 14·6%, 64·1% and 96·2% in treatment arms 1–3. Early wound healing was merely observed under octenidine wound gel treatment (n = 9), whereby lowest treatment costs were generated by octenidine wound gel alone (€20·34/dressing change). As a result, the octenidine wound gel is cost‐effective and well suitable for the treatment of chronic venous leg ulcers, considering both safety and promotion of wound healing.