Evaluation of validity of the new diabetic foot ulcer assessment scale in Indonesia

We developed a new assessment tool for diabetic foot ulcers because no such tool specifically for diabetic foot ulcer exists. The diabetic foot ulcer assessment scale (DFUAS) has 11 domain items. The minimum and maximum scores on this scale are 0 and 98, respectively; higher scores indicate more severe wounds. The aim of this study was to evaluate the concurrent validity, construct validity and predictive validity of DFUAS in Indonesia. A prospective cohort study was conducted on patients with diabetic foot ulcer at Kitamura wound clinic in Indonesia. A total of 62 patients with 70 diabetic foot ulcers were assessed with DFUAS tool, Bates‐Jensen wound assessment tool (BWAT), and pressure ulcer scale for healing (PUSH). Concurrent validity was determined by correlation of the DFUAS total score with the external criterion (BWAT, PUSH, and wound surface area). A comparison between the total DFUAS score and chronic wound status was made to determine construct validity. We also analyzed 41 wounds that were followed for 4 weeks to evaluate predictive validity. The correlation coefficient total scores of the DFUAS against the BWAT, PUSH, and wound surface area were 0.92, 0.87, and 0.82, respectively. The comparison of the total DFUAS score with chronic wound status was p < 0.001. The predictive validity test indicated that a DFUAS cutoff score of 12 produced the best balance of sensitivity, specificity, positive predictive value, and negative predictive value (89%, 71%, 86%, and 77%, respectively). In conclusion, the newly developed DFUAS is a valid tool for assessing diabetic foot ulcers.     

Relationship between items of DMIST and healing of diabetic foot ulcers

A monitoring tool for the wound-healing process of diabetic foot ulcers (DFUs) was developed. It comprises seven domains, namely, depth, maceration, inflammation/infection, size, tissue type of the wound bed, type of wound edge, and tunnelling/undermining. It was named “DMIST” based on the initials of its domains. Although DMIST is useful for assessing wound-healing processes, the monitoring items related to wound healing remain unclear, thereby making the selection of optimal care based on the assessment difficult. We identified the relationship between the DMIST items and wound healing. This study was a secondary analysis of five previous investigations and was conducted using DMIST based on the diabetic foot ulcer assessment scale score and DFU images. Multivariate logistic regression was used to calculate odds ratios (ORs) and 95% confidence intervals (95% CIs) after simultaneously controlling for potential confounders. The examined DFU healing status revealed that some DFUs healed at 4 weeks from baseline, whereas some DFUs did not. Variables considered in the models were the scores of each DMIST domain. The study population comprised 146 Indonesian patients and 33 Japanese patients. Depth, maceration, and size were associated with DFU healing at 4 weeks from baseline [depth: OR = 0.317 (95% CI: 0.145-0.693, P = 0.004); maceration: OR = 0.445 (95% CI: 0.221-0.896, P = 0.023); size: OR = 0.623 (95% CI: 0.451-0.862, P = 0.004)]. Our findings suggest that appropriate management of maceration promotes DFU healing.     

Validity and reliability of Chinese version of the new diabetic foot ulcer assessment scale

A specific assessment tool is urgently needed to guide effective wound care for diabetic foot ulcers. However, the tool has not been available in Chinese. We aimed to culturally translate and verify the validity and reliability of the new Diabetic Foot Ulcer Assessment Scale (DFUAS). The original scale was translated into Chinese according to the Brislin guidelines. Patients satisfying the inclusion and exclusion criteria were recruited. Each of the included foot ulcers was evaluated independently by two wound care specialists using the new DFUAS and by the third wound care specialists at the same time using the Bates-Jensen Wound Assessment Tool according to per guidelines. 210 diabetic foot ulcers were included for data analysis. The S-CVI of the Chinese version of the DFUAS was 0.96, and the I-CVIs ranged from 0.89 to 0.98. The total Cronbach's Alpha of the scale was 0.709, and the corrected item-total correlation of the items ranged from 0.4 to 0.872. The DFUAS had high inter-observer reliability of 0.997, and there were weak, moderate, and strong correlations between each pair of the items. The Bland–Altman plots showed a good agreement between the scale and the Bates-Jensen Wound Assessment Tool. We concluded that the Chinese version of the DFUAS showed good validity and reliability and is a reliable instrument for the assessment of diabetic foot ulcers.     

A single arm prospective feasibility study evaluating wound closure with a unique wearable device that provides intermittent plantar compression and offloading in the treatment of non‐healing diabetic foot ulcers

The incidence and economic burden of diabetic foot ulcers continues to rise throughout the world. In this prospective study, a unique device designed to offload the wound, enhance circulation and monitor patient compliance was evaluated for safety and efficacy. The device provides offloading and intermittent plantar compression to improve the pedal flow of oxygenated blood and support wound healing while recording patient use. Ten patients with non‐healing diabetic foot ulcers UTgrade 1A/Wagner grade 1 were treated weekly for up to 12 weeks. The primary endpoint was complete wound closure at 12 weeks, and secondary endpoints included healing time, percent area reduction and changes in pain using the visual analogue pain scale. Eight out of ten wounds healed within 12 weeks(80%), and the mean healing time was 41 days(95% CI:24.3–58.3). The percent area reduction was 75(SD:53.9). The baseline visual analogue pain scale was 4.5(2.9) as compared with 3.3(3.4) at end of study. No device‐related or serious adverse events were reported. This unique intermediate plantar compression and offloading device may be considered as an alternative for safe and effective for treatment of non‐healing diabetic foot ulcers. During treatment, wound healing was significantly accelerated, and pain was improved. Larger randomised controlled trials are underway to validate these early findings.     

A single arm prospective feasibility study evaluating wound closure with a unique wearable device that provides intermittent plantar compression and offloading in the treatment of non-healing diabetic foot ulcers

The incidence and economic burden of diabetic foot ulcers continues to rise throughout the world. In this prospective study, a unique device designed to offload the wound, enhance circulation and monitor patient compliance was evaluated for safety and efficacy. The device provides offloading and intermittent plantar compression to improve the pedal flow of oxygenated blood and support wound healing while recording patient use. Ten patients with non-healing diabetic foot ulcers UTgrade 1A/Wagner grade 1 were treated weekly for up to 12 weeks. The primary endpoint was complete wound closure at 12 weeks, and secondary endpoints included healing time, percent area reduction and changes in pain using the visual analogue pain scale. Eight out of ten wounds healed within 12 weeks(80%), and the mean healing time was 41 days(95% CI:24.3–58.3). The percent area reduction was 75(SD:53.9). The baseline visual analogue pain scale was 4.5(2.9) as compared with 3.3(3.4) at end of study. No device-related or serious adverse events were reported. This unique intermediate plantar compression and offloading device may be considered as an alternative for safe and effective for treatment of non-healing diabetic foot ulcers. During treatment, wound healing was significantly accelerated, and pain was improved. Larger randomised controlled trials are underway to validate these early findings.     

Effectiveness of a honey dressing for healing pressure ulcers.

OBJECTIVE: To compare the effect of a honey dressing vs an ethoxy-diaminoacridine plus nitrofurazone dressing in patients with pressure ulcers. DESIGN: This 5-week randomized clinical trial evaluated the effect of a honey dressing on pressure ulcer healing. SETTING AND SUBJECTS: Thirty-six patients with a total of 68 stage II or III pressure ulcers referred from a university hospital in Izmir were enrolled in the study. Twenty-six subjects completed the trial. INSTRUMENTS: Ulcers were measured with acetate tracings and Pressure Ulcer Scale for Healing (PUSH) evaluations. METHODS: Fifteen patients with 25 pressure ulcers were treated with honey dressings, and 11 patients with 25 pressure ulcers were treated with ethoxy-diaminoacridine plus nitrofurazone dressings. Wound healing was assessed weekly using the PUSH tool, version 3.0. The primary outcome measure was the change in PUSH tool scores in each group at 5 weeks. RESULTS: The two groups were statistically similar with regard to baseline and wound characteristics. After 5 weeks of treatment, patients who were treated by honey dressing had significantly better PUSH tool scores than subjects treated with the ethoxy-diaminoacridine plus nitrofurazone dressing (6.55 +/- 2.14 vs 12.62 +/- 2.15, P < .001). CONCLUSION: By week 5, PUSH tool scores showed that healing among subjects using a honey dressing was approximately 4 times the rate of healing in the comparison group. The use of a honey dressing is effective and practical.     

Comparison of two classification systems in predicting the outcome of diabetic foot ulcers: the Wagner grade and the Saint Elian Wound score systems

The aim of the study was to compare two systems of classification in a consecutive population with diabetic foot ulcers: the Wagner grade and the Saint Elian Wound Score System (SEWSS). Sociodemographic information, patient‐related and ulcer‐related data at first presentation was recorded, and the patients were followed up until wound healing or accepting major amputation or for 24 weeks. One hundred eighty‐six patients were included in the study, of which 172 patients were completely followed up. Among the remaining 172 patients, 53.5% (n = 92) were healed without minor amputation, 32% (n = 55) were healed with minor amputation, 9.3% (n = 16) were not healed at study termination, 3.5% (n = 6) died and 1.7% (n = 3) underwent major amputation. The median healing time for Wagner 1, Wagner 2, Wagner 3, and Wagner 4 were 23, 50, 54, 119 days, respectively. The log‐rank test showed significant differences in healing time for Wagner 1, Wagner 2, Wagner 3, and Wagner 4; The median healing time for SEWSS I, SEWSS II and SEWSS III were 12, 51, and 150 days, respectively. The log‐rank test showed significant differences in healing time for SEWSS I, SEWSS II and SEWSS III. Cox regression analysis showed a decreasing probability of healing with or without minor amputation with a higher SEWSS value, an increase in the SEWSS by one score reduced the probability for healing by 24%. ROC analysis showed Wagner 3 and a cut‐point 17 of SEWSS had the highest Youden's index. Both the Wagner grade and SEWSS system were associated with the ulcer healing time for the patients with active DFUs. The SEWSS score makes it a better prediction tool of DFU outcome synthetically.     

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。     

Predictive validity of weekly monitoring of wound status using DESIGN‐R score change for pressure ulcer healing: A multicenter prospective cohort study

There are few studies on predictive validity of methods to monitor the healing process of pressure ulcers. We evaluated whether the change of DESIGN‐R (rating) score could predict subsequent healing, and determined the optimal cutoff points. In a multicenter prospective cohort study, patients were followed until wound healing or censoring. Wound severity was evaluated by the DESIGN‐R tool every week, and the score change was calculated over 1–4 weeks (n = 411, 286, 224, and 170, respectively). In the multivariate analyses stratified by depth, a one‐point improvement in DESIGN‐R score over any period was positively associated with healing within the next 30 days independent of initial wound severity (hazard ratios over each 1–4 weeks ranging from 1.16 to 1.33 for superficial ulcers and from 1.21 to 1.27 for deep ulcers; all p < 0.05). The optimal cutoff points over 1–4 weeks were set as negative change for superficial ulcers and as positive change of ≥two points for deep ulcers. Nonhealing rate was higher for ulcers with DESIGN‐R score change below the cutoff points than that aforementioned for both depths. Weekly monitoring by the DESIGN‐R tool will be advantageous for evaluating prognosis of pressure ulcers independent of initial wound severity and depth.     

A simple and effective approach for the treatment of diabetic foot ulcers with different Wagner grades

Diabetic foot infections are the major cause of morbidity. Infection is the common sequel of diabetic foot ulceration that leads to delayed wound healing. These infections are difficult to control. If not addressed well in time, they may lead to amputation of foot. An attempt has been made to develop simple and effective treatment modality by using citric acid as a sole antimicrobial agent to control diabetic foot infections not responding to conventional treatment. Hundred and fifteen cases of diabetic foot ulcers of different Wagner grades infected with a variety of bacteria were investigated for culture and susceptibility, and susceptibility to citric acid. Citric acid gel was applied to ulcer to determine its efficacy in the management of diabetic foot ulcers with different Wagner grades. Citric acid gel was found effective in the control of foot infections; especially in Wagner grades I and II, the success rate was found to be more than 94%. In Wagner grade III also, it was found effective in complete healing of ulcers without deep osteomyelitis. Citric acid treatment is effective in the control of diabetic foot infections and in successful management of diabetic foot ulcers with Wagner grades I and II, and even with Wagner grade III, without deep osteomyelitis.     

Improved healing of chronic diabetic foot wounds in a prospective randomised controlled multi‐centre clinical trial with a microvascular tissue allograft

This study assesses the impact of a processed microvascular tissue (PMVT) allograft on wound closure and healing in a prospective, single‐blinded, multi‐centre, randomised controlled clinical trial of 100 subjects with Wagner Grade 1 and 2 chronic neuropathic diabetic foot ulcerations. In addition to standard wound care, including standardised offloading, the treatment arm received PMVT while the control arm received a collagen alginate dressing. The primary endpoint was complete wound closure at 12 weeks. Secondary endpoints assessed on all subjects were percent wound area reduction, time to healing, and local neuropathy. Novel exploratory sub‐studies were conducted for wound area perfusion and changes in regional neuropathy. Weekly application of PMVT resulted in increased complete wound closure at 12 weeks (74% vs 38%; P = .0003), greater percent wound area reduction from weeks four through 12 (76% vs 24%; P = .009), decreased time to healing (54 days vs 64 days; P = .009), and improved local neuropathy (118% vs 11%; P = .028) compared with the control arm. Enhanced perfusion and improved regional neuropathy were demonstrated in the sub‐studies. In conclusion, this study demonstrated increased complete healing with PMVT and supports its use in treating non‐healing DFUs. The observed benefit of PMVT on the exploratory regional neuropathy and perfusion endpoints warrants further study.     

Clinical Classification of Bioengineered Skin Use and Its Correlation with Healing of Diabetic and Venous Ulcers

BACKGROUND: Chronic wounds are being treated with bioengineering skin constructs. Yet, there is no standard way of assessing these wounds. We developed a classification system to evaluate wounds after construct application. The classification system evaluates the early clinical effect of bioengineered skin and early construct appearance giving a total score named the skin substitute score. OBJECTIVE: Apply classification system to both venous and diabetic foot ulcers and determine whether classification system has validity and predictability for healing. METHODS: Evaluated serial photographs in 83 and 78 patients with diabetic foot ulcers and in 84 and 83 patients with venous ulcer on Days 7 and 14, respectively, treated with a bilayered bioengineered skin construct. Applied the classification system and determined the percentages of healed patients. RESULTS: There was a significant correlation between better skin substitute score and complete wound closure for both venous ulcers p=0.002 on Day 7 and p=0.01 on Day 14) and diabetic foot ulcers p=0.0005 on Day 7 and p<0.0001 on Day 14). CONCLUSION: Optimal clinical effect was associated with complete wound closure. As the clinical effect becomes less than optimal continued clinical persistence of the construct becomes important. This classification system seems to have validity in predicting complete wound closure in wounds treated with a bilayered bioengineered skin construct.     

The value of a wound score for diabetic foot infections in predicting treatment outcome: A prospective analysis from the SIDESTEP trial

Scoring the severity of a diabetic foot wound infection may help assess the severity, determine the type and urgency of antibiotic and surgical treatment needed, and predict clinical outcomes. We developed a 10-item diabetic foot infection wound score (results could range from 3 to 49 [least to most severe]) incorporating semi-quantitative grading of both wound measurements and various infection parameters. Using data from a prospective diabetic foot infection antibiotic trial (SIDESTEP), we evaluated the score's accuracy in predicting outcome, analyzed its components and tested it for consistency, construct, and validity. Wound scores for 371 patients significantly correlated with the clinical response; it was favorable at the follow-up assessment in 94.8% with a baseline score ≤12 compared with 77.0% with a score >19. Scores demonstrated good internal consistency (Cronbach's α >0.70 to <0.95). Patients with more severe wounds had higher scores, supporting construct validity. Excluding scores for wound discharge (purulent and nonpurulent), leaving an eight-item score, provided better measurement statistics. This easily performed wound score appears to be a reliable, valid, and useful tool for predicting clinical outcomes. Further validation studies in different patient populations should refine the items included.     

Within-patient randomised clinical trial exploring the development of microskin implantation in the treatment of pressure ulcers

Pressure injury often seriously affects the life quality of aged patients, especially the long-term bedridden casualties. Widely adopted by different disciplines, negative pressure suction has its role in pressure injury. Microskin implantation has been demonstrated powerful in increasing the expansion ratio of donor area-derived skin and accelerating wound healing by forming “skin islands”. The study was designed to evaluate the efficacy and safety of additional use of bedside microskin implantation in the palliative care of pressure injury of aged patients who cannot tolerate surgical treatment as a supplement for standard negative pressure suction. An open-label within-patient RCT was conducted in aged patients with pressure injury. Sixteen patients were enrolled. After granulation tissues formed, half of a pressure injury was randomised to receive the negative pressure suction as the control group, and the other half exposed to additional bedside microskin implantation as the experimental group. Efficacy was evaluated within 1 month after treatment, and the primary endpoints included the wound healing rate and pressure ulcer scale for healing (PUSH) scores. The secondary outcomes included survival rate of implanted microskin, pain intensity assessment, satisfaction surveys from patients or their family, and pressure ulcer healing complications. Sixteen patients completed the study. After 14 days of operation, 5.63 ± 1.78 out of 10 pieces of implanted microskin survived and formed neonatal epithelium. The wound healing rates of the control group and the experimental group at 1 month were (26.17 ± 9.03%) and (35.95 ± 16.02%), respectively (P < .01). The mean PUSH score before the surgery was 12.38 ± 2.23. At 1 month after surgery, the mean difference of PUSH score from baseline was 2.13 ± 0.96 in the control group and 2.81 ± 0.83 in the experimental group (P < .01). The treatment of microskin implantation did not cause additional pain or complications to the patients. Accompanied by a better ulcer status, the majority of patients or their guardians have a high degree of acceptance towards the microskin implantation. Bedside microskin implantation could accelerate wound healing with lower PUSH scores. As a complementary palliative treatment, supplementary microskin implantation is effective and well tolerated.     

Early healing rates and wound area measurements are reliable predictors of later complete wound closure

This study was undertaken to determine if healing rates are reliable early predictors of ultimate complete wound closure in venous leg ulcers and diabetic foot wounds. We conducted a retrospective analysis of 306 venous leg ulcers and 241 diabetic foot ulcers enrolled in two large controlled, prospective, randomized pivotal trials to compare topical wound treatments, to determine whether certain early markers of healing could be correlated with later total wound closure. Two-sided tests at 95% confidence demonstrated that wound margin advance, initial healing rate, percent wound surface area reduction, and wound healing trajectories (all p <0.001) were powerful predictors of complete wound healing at 12 weeks. Wounds with poor healing progress by these criteria at 4 weeks were highly likely to remain unhealed after 8 additional weeks of treatment. Analysis of the diabetic foot ulcers and venous leg ulcers subgroups separately demonstrated consistent statistical test results with high significance; similarly, the results remained valid independent of the topical treatment used. The early prediction of eventual wound healing or nonhealing using early healing rates may enable more efficient triage of patients to advanced healing technologies. We believe that these surrogate markers are robust predictors of healing regardless of wound etiology and that they merit wider use in clinical trials and routine patient care.     

Transverse Tibial Bone Transport Enhances Distraction Osteogenesis and Vascularization in the Treatment of Diabetic Foot

ObjectiveTo investigate the effect of transverse tibial bone transport on the treatment of Wagner Stage 4 diabetic foot.MethodsFrom January 2017 to October 2019, a total of 19 patients with Wagner Stage 4 diabetic foot ulcers were recruited. All patients were treated with transverse tibial bone transport. A detailed follow‐up was carried out at 1 week, 1 month, 3 months, 6 months, and 1 year after surgery. The wound healing rate and the limb salvage rate at 1 year after the surgery were evaluated. Preoperative and 3‐month postoperative digital subtraction angiography (DSA) were obtained. The level of vascular endothelial growth factor (VEGF), basic fibroblast growth factor (bFGF), epidermal growth factor (EGF) and platelet‐derived growth factor (PDGF) before surgery and on 1st, 4th, 11th, 18th, 28^th, and 35th days after surgery were measured. Operation time, intraoperative blood loss, postoperative complications, visual analog scale (VAS) pain score, skin temperature, Semmes‐weinstein monofilament (SWM), and ankle brachial index (ABI) were also assessed.ResultsThe wound healing rate and the limb salvage rate were both 94.74% in the patients at 1 year after the surgery. DSA showed the thickening of the calf and foot arteries, clear visualization, and a rich vascular network. The levels of VEGF, bFGF, and PDGF on the 11th, 18th, 28^th, and 35th days after surgery were significantly higher than those before surgery (p < 0.05). The EGF level on the 18th, 28th, and 35th days after surgery was significantly higher than that before surgery (p < 0.05). Superficial wound complications occurred in one patient during the hospitalization. There was no movement area infection, skin flap necrosis, tibial fracture, loosening of the external fixator, or rupture in study.ConclusionTransverse tibial bone transport can improve the blood circulation of the affected limbs, promote the healing of diabetic foot wounds, and reduce the amputation rate of the affected limbs. Transverse tibial bone transport can promote the healing of Wagner Stage 4 diabetic foot.     

Wound healing: total contact cast vs. custom-made temporary footwear for patients with diabetic foot ulceration

The objective of this study was to compare the effectiveness of irremovable total-contact casts (TCC) and custom-made temporary footwear (CTF) to heal neuropathic foot ulcerations in individuals with diabetes. In this prospective clinical trial, 43 patients with plantar ulcer Grade 1 or 2 (Wagner scale) were randomized to one of two off-loading modalities: TCC or CTF. Outcomes assessed were wound surface area reduction (cm2) and time to wound healing (days) at 2, 4, 8 and 16 weeks. To evaluate safety, possible side effects were recorded at each follow-up visit. The results showed no significant difference in wound surface area reduction (adjusted for baseline wound surface) at 2, 4, 8 or 16 weeks (adjusted mean difference 0.10 cm2; 95% CI -0.92-0.72 at 16 weeks). At 16 weeks, 12 patients had a completely healed ulcer, 6 per group. The median time to healing was shorter for the patients using a cast (52 vs. 90 days, p = 0.26). Five patients with TCC and two with CTF developed device-related complications. It was concluded that: (i) the rate of wound healing is not significantly different for patients treated with CTF or TCC. The difference in wound surface area was small and not significant at any time during follow-up; and (ii) the difference in healing time (38 days) may have attained statistical significance if the numbers in these sub-groups (2 x 6) had been higher. Since there appears to be little difference in effectiveness between both off-loading modalities, further investigation into the benefits of CTF is warranted.     

Regenerating matrix-based therapy for chronic wound healing: a prospective within-subject pilot study

The aim of this study was to determine whether a skin-specific bioengineered regenerating agent (RGTA) heparan sulphate mimetic (CACIPLIQ20) improves chronic wound healing. The design of this article is a prospective within-subject study. The setting was an urban hospital. Patients were 16 African-American individuals (mean age 42 years) with 22 wounds (mean duration 2.5 years) because of either pressure, diabetic, vascular or burn wounds. Two participants each were lost to follow-up or removed because of poor compliance, resulting in 18 wounds analysed. Sterile gauze was soaked with CACIPLIQ20 saline solution, placed on the wound for 5 min, then removed twice weekly for 4 weeks. Wounds were otherwise treated according to the standard of care. Twenty-two percent of wounds fully healed during the treatment period. Wounds showed a 15.2-18.1% decrease in wound size as measured by the vision engineering research group (VERG) digital wound measurement system and total PUSH scores, respectively, at 4 weeks (P = 0.014 and P = 0.003). At 8 weeks there was an 18-26% reduction in wound size (P = 0.04) in the remaining patients. Wound-related pain measured by the visual analogue pain scale and the wound pain scale declined 60% (P = 0.024) and 70% (P = 0.001), respectively. Patient and clinician satisfaction remained positive throughout the treatment period. It is concluded that treatment with CACIPLIQ20 significantly improved wound-related pain and may facilitate wound healing. Patient and clinician satisfaction remained high throughout the trial.     

To evaluate the efficacy of an acellular Flowable matrix in comparison with a wet dressing for the treatment of patients with diabetic foot ulcers: a randomized clinical trial

The authors aimed to evaluate the efficacy of an advanced wound matrix (Integra Flowable Wound Matrix, Integra LifeScience Corp, Plainsboro, NJ, USA) for treating wounds with irregular geometries versus a wet dressing in patients with diabetic foot ulcers. Sixty patients with diabetic foot ulcers (Grades 3 Wagner) were included in this randomized clinical trial. The study was conducted in the General Surgery Unit and Geriatric of the Second University of Naples, Italy, in the last 12 months. Forty-six cases of diabetic foot ulcers were equally and randomly divided into control and test groups. The first group treated with Integra Flowable Wound Matrix, while the control group with a wet dressing. Both groups were evaluated once a week for 6 weeks to value the degree of epithelialization and granulation tissue of the wound. The complete healing rate in the whole study population was 69.56% (Integra Flowable Wound Matrix group, 86.95%, control group, 52.17%; p = 0.001). Amputation and rehospitalization rates were higher in the control group compared to the first group, therefore, the difference was statistically significant (p = 0.0019; p = 0.028, respectively). The Integra Flowable Wound Matrix, was significantly superior, compared to the wet dressing, by promoting the complete healing of diabetic foot ulcers. Ease of use, absence of adverse effects, and a facilitated wound healing process are among the properties of the matrix. These characteristics make it appropriate in the management of diabetic foot ulcers. Additional research will shed more light on the promising advantages of this material in healing diabetic foot ulcers.     

Wound healing trajectories as predictors of effectiveness of therapeutic agents

BACKGROUND: One goal of wound healing research is to discover agents to accelerate healing. Regulatory agencies have suggested stringent criteria to determine efficacy, that of 100% wound closure. Data analysis at a single point such as 100% closure does not provide detailed information about agent effectiveness over the entire span of healing. HYPOTHESIS: Wound healing trajectories can provide such information and can be used to demonstrate utility as alternative end points for wound healing trials. DESIGN: Data from 160 patients in 11 clinical trials of diabetic foot ulcers conducted at 2 centers were evaluated. Wound healing trajectories were constructed for patients whose wounds healed (100% closure) and those whose did not (<100% closure) over a 20-week period. The percentage of patients achieving total healing vs time of treatment was plotted and divided into patients receiving a test agent or placebo. RESULTS: The healing trajectories were almost identical for patients achieving complete healing at the 2 centers, as were the trajectories for patients with less than 100% closure. However, the trajectories of patients achieving total healing were significantly different from those not achieving 100% closure. Fifty-two percent of all patients achieved 100% healing by 20 weeks; 61% of patients receiving an experimental agent had total healing compared with 39% of placebo-treated patients. Linear regression suggested that all patients would achieve total healing by 37 weeks. CONCLUSIONS: Since wound healing trajectories for diabetic foot ulcers treated at 2 centers so closely mimic one another, trajectories might be useful efficacy end points, and used to compare significant points along a continuum rather than a single static end point. Shifting of the wound healing trajectory from an impaired to a more ideal course may be considered when determining efficacy of new wound treatments.