Venous leg ulcer management in clinical practice in the UK: costs and outcomes

The aim of this study was to estimate the patterns of care and annual levels of health care resource use attributable to managing venous leg ulcers (VLUs) in clinical practice by the UK's National Health Service (NHS) and the associated costs of patient management. This was a retrospective cohort analysis of the records of 505 patients in The Health Improvement Network (THIN) Database. Patients' characteristics, wound‐related health outcomes and health care resource use were quantified, and the total NHS cost of patient management was estimated at 2015/2016 prices. Overall, 53% of all VLUs healed within 12 months, and the mean time to healing was 3·0 months. 13% of patients were never prescribed any recognised compression system, and 78% of their wounds healed. Of the 87% who were prescribed a recognised compression system, 52% of wounds healed. Patients were predominantly managed in the community by nurses with minimal clinical involvement of specialist clinicians. Up to 30% of all the VLUs may have been clinically infected at the time of presentation, and only 22% of patients had an ankle brachial pressure index documented in their records. The mean NHS cost of wound care over 12 months was an estimated £7600 per VLU. However, the cost of managing an unhealed VLU was 4·5 times more than that of managing a healed VLU (£3000 per healed VLU and £13 500 per unhealed VLU). This study provides important insights into a number of aspects of VLU management in clinical practice that have been difficult to ascertain from other studies and provides the best estimate available of NHS resource use and costs with which to inform policy and budgetary decisions.     

Cost‐effectiveness of becaplermin gel on wound healing of diabetic foot ulcers

We sought to determine the long‐term cost effectiveness (payer's perspective) of becaplermin gel plus good wound care (BGWC) vs. good wound care (GWC) alone in terms of wound healing and risk of amputation in patients with diabetic foot ulcers (DFUs). Outcomes data were derived from a propensity score‐matched cohort from the Curative Health Services database between 1998 and 2004, which was followed for 20 weeks. A four‐state Markov model was used to predict costs and outcomes of wound healing and risk of amputation for BGWC vs. GWC alone over 1 year in patients with DFU. The primary outcome was closed‐wound weeks. Transition probabilities for healing and amputation were derived from the aforementioned propensity score‐matched cohorts. Ulcer recurrence was estimated from the medical literature. Utilization for becaplermin was calculated using the dosing algorithm in the product labeling. Of 24,898 eligible patients, 9.6% received BGWC. Based on the model, patients treated with BGWC had substantially more closed‐wound weeks compared with GWC (16.1 vs. 12.5 weeks, respectively). More patients receiving BGWC had healed wounds at 1 year compared with those receiving GWC (48.1% vs. 38.3%). Risk of amputation was lower in the BGWC cohort (6.8% vs. 9.8%). Expected annual direct costs for DFU were $21,920 for BGWC and $24,640 for GWC. BGWC was economically dominant over GWC, providing better outcomes at a lower cost in patients with DFU. Compared with GWC alone, BGWC is more effective in healing wounds and lowering amputation risk, thereby decreasing long‐term costs for DFU.     

Health economic burden that different wound types impose on the UK's National Health Service

The aim of this study was to estimate the patterns of care and annual levels of health care resource use attributable to the management of different wound types by the UK's National Health Service (NHS) in 2012/2013 and the annual costs incurred by the NHS in managing them. This was a retrospective cohort analysis of the records of 2000 patients in The Health Improvement Network (THIN) Database. Patients' characteristics, wound‐related health outcomes and all health care resource use were quantified, and the total NHS cost of patient management was estimated at 2013/2014 prices. The NHS managed an estimated 2·2 million patients with a wound during 2012/2013. Patients were predominantly managed in the community by general practitioners (GPs) and nurses. The annual NHS cost varied between £1·94 billion for managing 731 000 leg ulcers and £89·6 million for managing 87 000 burns, and associated comorbidities. Sixty‐one percent of all wounds were shown to heal in an average year. Resource use associated with managing the unhealed wounds was substantially greater than that of managing the healed wounds (e.g. 20% more practice nurse visits, 104% more community nurse visits). Consequently, the annual cost of managing wounds that healed in the study period was estimated to be £2·1 billion compared with £3·2 billion for the 39% of wounds that did not heal within the study year. Within the study period, the cost per healed wound ranged from £698 to £3998 per patient and that of an unhealed wound ranged from £1719 to £5976 per patient. Hence, the patient care cost of an unhealed wound was a mean 135% more than that of a healed wound. Real‐world evidence highlights the substantial burden that wounds impose on the NHS in an average year. Clinical and economic benefits to both patients and the NHS could accrue from strategies that focus on (a) wound prevention, (b) accurate diagnosis and (c) improving wound‐healing rates.     

Evidence of differential microbiomes in healing versus non‐healing diabetic foot ulcers prior to and following foot salvage therapy

Diabetic foot ulcers (DFU) contribute to 80% of lower extremity amputations. Although physicians currently rely on clinical signs along with non‐specific biomarkers of infection, such as erythrocyte sedimentation rate and C‐reactive protein, to diagnose and monitor DFU, there is no specific and sensitive measure available to monitor or prognosticate the success of foot salvage therapy (FST). To address this we performed a prospective, observational microbiome analysis to test the hypotheses that: (i) the initial microbiomes of healed versus non‐healed DFU are distinct; (ii) the microbial load, diversity and presence of pathogenic organism of the DFU change in response to antibiotics treatment; and (iii) the changes in the DFU microbiome during treatment are prognostic of clinical outcome. To test this, microbiome analyses were performed on 23 DFU patients undergoing FST, in which wound samples were collected at zero, four, and eight weeks following wound debridement and antibiotics treatment. Bacterial abundance was determined using quantitative polymerase chain reaction (qPCR). Eleven patients healed their DFU, while FDT failed to heal DFU in the other 12 patients. Microbiome results demonstrated that healing DFUs had a larger abundance Actinomycetales and Staphylococcaceae (p < 0.05), while DFUs that did not heal had a higher abundance of Bacteroidales and Streptococcaceae (p < 0.05). FST marked increases Actinomycetales in DFU, and this increase is significantly greater in patients that healed (p < 0.05). Future studies to confirm the differential microbiomes, and that increasing Actinomycetales is prognostic of successful FST are warranted. Statement of Clinical Significance: Tracking changes in the prevalence of pathogens in diabetic foot ulcers may be a clinical tool for monitoring treatment response to foot salvage therapy and prognosticating the need for further surgical intervention. The initial wound sample microbiome may provide important prognostic information on the eventual clinical outcome of foot salvage therapy. It may serve as an important clinical tool for patient counseling and making surgical decision of pursuing foot salvage versus amputation. © 2019 Orthopaedic Research Society. Published by Wiley Periodicals, Inc. J Orthop Res 37:1596–1603, 2019.     

Economic evaluation of Vacuum Assisted Closure® Therapy for the treatment of diabetic foot ulcers in France

The objective of the study was to assess the cost‐effectiveness of Vacuum Assisted Closure^® (V.A.C.^®) Therapy compared with advanced wound care (AWC) for the treatment of diabetic foot ulcers (DFUs) in France. A cost‐effectiveness model intended to reflect the management of DFUs was updated for the French setting. The Markov model follows the progression of 1000 hypothetical patients over a 1‐year period. The model was populated with French‐specific data, obtained from published sources and clinical experts. The analysis evaluated costs and health outcomes, in terms of quality‐adjusted life‐years (QALYs), wounds healed and amputations, from the perspective of the payer. The patients treated with V.A.C.^® Therapy experienced more QALYs (0·787 versus 0·784) and improved healing rates (50·2% versus 48·5%) at a lower total cost of care (€24 881 versus €28 855 per patient per year) when compared with AWC. Sensitivity analyses conducted around key model parameters indicated that the results were affected by hospital resource use and costs. DFU treatment using V.A.C.^® Therapy in France was associated with lower costs, additional QALYs, more healed ulcers and fewer amputations than treatment with AWC. V.A.C.^® Therapy was therefore found to be the dominant treatment option.     

The efficacy and safety of Grafix® for the treatment of chronic diabetic foot ulcers: results of a multi‐centre,controlled, randomised,blinded, clinical trial

In a randomised, controlled study, we compared the efficacy of Grafix^®, a human viable wound matrix (hVWM) (N = 50), to standard wound care (n = 47) to heal diabetic foot ulcers (DFUs). The primary endpoint was the proportion of patients with complete wound closure by 12 weeks. Secondary endpoints included the time to wound closure, adverse events and wound closure in the crossover phase. The proportion of patients who achieved complete wound closure was significantly higher in patients who received Grafix (62%) compared with controls (21%, P = 0·0001). The median time to healing was 42 days in Grafix patients compared with 69·5 days in controls (P = 0·019). There were fewer Grafix patients with adverse events (44% versus 66%, P = 0·031) and fewer Grafix patients with wound‐related infections (18% versus 36·2%, P = 0·044). Among the study subjects that healed, ulcers remained closed in 82·1% of patients (23 of 28 patients) in the Grafix group versus 70% (7 of 10 patients) in the control group (P = 0·419). Treatment with Grafix significantly improved DFU healing compared with standard wound therapy. Importantly, Grafix also reduced DFU‐related complications. The results of this well‐controlled study showed that Grafix is a safe and more effective therapy for treating DFUs than standard wound therapy.     

A clinical trial of Integra Template for diabetic foot ulcer treatment

Individuals with diabetes mellitus are at an increased risk of developing a diabetic foot ulcer (DFU). This study evaluated the safety and efficacy of Integra Dermal Regeneration Template (IDRT) for the treatment of nonhealing DFUs. The Foot Ulcer New Dermal Replacement Study was a multicenter, randomized, controlled, parallel group clinical trial conducted under an Investigational Device Exemption. Thirty‐two sites enrolled and randomized 307 subjects with at least one DFU. Consented patients were entered into the 14‐day run‐in phase where they were treated with the standard of care (0.9% sodium chloride gel) plus a secondary dressing and an offloading/protective device. Patients with less than 30% reepithelialization of the study ulcer after the run‐in phase were randomized into the treatment phase. The subjects were randomized to the control treatment group (0.9% sodium chloride gel; n = 153) or the active treatment group (IDRT, n = 154). The treatment phase was 16 weeks or until confirmation of complete wound closure (100% reepithelialization of the wound surface), whichever occurred first. Following the treatment phase, all subjects were followed for 12 weeks. Complete DFU closure during the treatment phase was significantly greater with IDRT treatment (51%) than control treatment (32%; p = 0.001) at sixteen weeks. The median time to complete DFU closure was 43 days for IDRT subjects and 78 days for control subjects in wounds that healed. The rate of wound size reduction was 7.2% per week for IDRT subjects vs. 4.8% per week for control subjects (p = 0.012). For the treatment of chronic DFUs, IDRT treatment decreased the time to complete wound closure, increased the rate of wound closure, improved components of quality of life and had less adverse events compared with the standard of care treatment. IDRT could greatly enhance the treatment of nonhealing DFUs.     

A prospective,randomised, controlled,multicentre clinical trial examining healing rates,safety and cost to closure of an acellular reticular allogenic human dermis versus standard of care in the treatment of chronic diabetic foot ulcers

Acellular dermal matrices can successfully heal wounds. This study's goal was to compare clinical outcomes of a novel, open‐structure human reticular acellular dermis matrix (HR‐ADM) to facilitate wound closure in non‐healing diabetic foot ulcers (DFUs) versus DFUs treated with standard of care (SOC). Following a 2‐week screening period in which DFUs were treated with offloading and moist wound care, patients were randomised to either SOC alone or HR‐ADM plus SOC applied weekly for up to 12 weeks. At 6 weeks, the primary outcome time, 65% of the HR‐ADM‐treated DFUs healed (13/20) compared with 5% (1/20) of DFUs that received SOC alone. At 12 weeks, the proportions of DFUs healed were 80% and 20%, respectively. Mean time to heal within 12 weeks was 40 days for the HR‐ADM group compared with 77 days for the SOC group. There was no incidence of increased adverse or serious adverse events between groups or any adverse events related to the graft. Mean and median graft costs to closure per healed wound in the HR‐ADM group were $1475 and $963, respectively. Weekly application of HR‐ADM is an effective intervention for promoting closure of non‐healing DFUs.     

Statins may be associated with six‐week diabetic foot ulcer healing

Diabetic foot ulcers (DFUs) affect 1.5 million Americans annually, of which only a minority heal with standard care, and they commonly lead to amputation. To improve care, investigations are underway to better understand DFU pathogenesis and develop more effective therapies. Some currently used medications may improve healing. One small, randomized clinical trial found statins improve DFU healing. In this secondary analysis of a large multisite prospective observational cohort of 139 patients with DFUs receiving standard care, we investigated whether there was an association between 6‐week DFU wound size reduction and use of a variety of medications including alpha‐blockers, beta‐blockers, angiotensin converting enzyme inhibitors (ACEi) and statins. We found no significant (p < 0.05) association between six‐week wound reduction and use of any of the evaluated drugs; however, statins did trend toward an association (p = 0.057). This suggests a potential benefit of statins on DFU healing, and larger, targeted studies are warranted.     

Saving diabetic foot ulcers from amputation by surgical debridement and maggot therapy: A case report

Introduction and importanceA diabetic foot ulcer (DFU) is one of the major diabetes complications that may lead to limb amputation. Amputation can have profound physical and psychological effects on an individual's life. Nowadays, the prevention of limb amputation and treatment of DFUs are known as the major health challenges.Case presentationThe present case report is of a 72-year-old woman with a 20-year history of type 2 diabetes who has had asymmetrical and superficial DFUs with sizes of 6 × 5 cm and 3 × 3 cm on the heel and the sole of the right foot, respectively. The ulcers were infected by S. aureus and E. coli. The patient had been hospitalized several times for receiving treatment, and not only the ulcers had not been healed, but also they had considerably extended so that the risk of foot amputation had been greatly increased. The patient was transferred to our wound care service. After conducting one session of surgical debridement, the patient underwent ten sessions of maggot therapy (one session every two days) using sterile Lucilia sericata. After about six months, the patient's DFUs were completely healed.Clinical discussionDFU can affect a patient's quality of life and lead to infection, sepsis, amputation, and even patient death. Therefore, using effective treatment approaches is very important for the management of DFUs.ConclusionThe combined use of surgical debridement and maggot therapy is a safe and effective method for improving diabetic foot ulcers and preventing amputation.     

The Society for Vascular Surgery Wound,Ischemia, and foot Infection (WIfI) classification system predicts wound healing but not major amputation in patients with diabetic foot ulcers treated in a multidisciplinary setting

ObjectiveThe Society for Vascular Surgery Wound, Ischemia, and foot Infection (WIfI) threatened limb classification has been shown to correlate well with risk of major amputation and time to wound healing in heterogeneous diabetic and nondiabetic populations. Major amputation continues to plague the most severe stage 4 WIfI patients, with 1-year amputation rates of 20% to 64%. Our aim was to determine the association between WIfI stage and wound healing and major amputation among patients with diabetic foot ulcers (DFUs) treated in a multidisciplinary setting.MethodsAll patients presenting to our multidisciplinary DFU clinic from July 2012 to December 2015 were enrolled in a prospective database. Wound healing and major amputation were compared for patients stratified by WIfI classification.ResultsThere were 217 DFU patients with 439 wounds (mean age, 58.3 ± 0.8 years; 58% male, 63% black) enrolled, including 28% WIfI stage 1, 11% stage 2, 33% stage 3, and 28% stage 4. Peripheral arterial disease and dialysis were more common in patients with advanced (stage 3 or 4) wounds (P ≤ .05). Demographics of the patients, socioeconomic status, and comorbidities were otherwise similar between groups. There was a significant increase in the number of active wounds per limb at presentation with increasing WIfI stage (stage 1, 1.1 ± 0.1; stage 4, 1.4 ± 0.1; P = .03). Mean wound area (stage 1, 2.6 ± 0.6 cm²; stage 4, 15.3 ± 2.8 cm²) and depth (stage 1, 0.2 ± 0.0 cm; stage 4, 0.8 ± 0.1 cm) also increased progressively with increasing wound stage (P < .001). Minor amputations (stage 1, 18%; stage 4, 56%) and revascularizations (stage 1, 6%; stage 4, 55%) were more common with increasing WIfI stage (P < .001). On Kaplan-Meier analysis, WIfI classification was predictive of wound healing (P < .001) but not of major amputation (P = .99). For stage 4 wounds, the mean wound healing time was 190 ± 17 days, and risk of major amputation at 1 year was 5.7% ± 3.2%.ConclusionsAmong patients with DFU, the WIfI classification system correlated well with wound healing but was not associated with risk of major amputation at 1 year. Although further prospective research is warranted, our results suggest that use of a multidisciplinary approach for DFUs may augment healing time and reduce amputation risk compared with previously published historical controls of standard wound care among patients with advanced stage 4 disease.     

High‐dose folic acid and its effect on early stage diabetic foot ulcer wound healing

High‐dose folic acid (HDFA; vitamin B9)—5 mg, given daily, has not been evaluated as a treatment to improve early stage‐diabetic foot ulcer (ES‐DFU) wound healing. However, HDFA has been demonstrated to correct: (a) endothelial dysfunction and decreased nitric oxide (NO) bioavailability, associated with type‐2 diabetes mellitus (T2DM); and (b) hyperhomocysteinemia (HHcy) that may promote impaired DFU‐wound healing. Measures of wound area (cm²) reduction (wound closure; WC), over a 4‐week period (4 W‐WC), greater than 50% of the wound area, have been reported as a robust indicator of the potential for DFU‐wound healing. By using this model, we examined the effectiveness of a wound treatment in promoting progressive healing and complete wound closure for the chronic, nonhealing DFU‐wound. To investigate this possible relationship between HDFA and ES‐DFU wound healing, a retrospective cohort study of medical records, between November 2018 and April 2019, was performed for Veterans with T2DM and ES‐DFUs following treatment with HDFA. During the study period 29 (n = 29) Veterans with ES‐DFU wounds who received HDFA treatment were identified. Medical record reviews of this retrospective cohort of ES‐DFU Veterans receiving HDFA report 90% (26/29) experiencing complete DFU‐wound closure during the study period. Of the 29 Veterans with ES‐DFUs receiving HDFA, the medical records of nine (30%), with healed wounds, provided documentation suitable for 4 W‐WC, pre‐ and post‐HDFA treatment study comparisons. This study documents significant (P < .05) improvements comparing 4 W‐WC values for standard treatment for Veterans with poorly progressing, worsening or stagnating ES‐DFU‐wounds to those for the same subjects following HDFA treatment. These observations suggest that chronic ES‐DFUs treated with HDFA may experience significantly improved wound closure and complete healing (re‐epithelialization) when compared with standard treatments without HDFA. With validation from RCTs, HDFA may be established as an effective treatment to promote wound healing and closure for nonhealing ES‐DFUs.     

Effective management of patients with diabetes foot ulcers: outcomes of an Interprofessional Diabetes Foot Ulcer Team

A longitudinal observational study on a convenience sample was conducted between 4 January and 31 December of 2010 to evaluate clinical outcomes that occur when a new Interprofessional Diabetes Foot Ulcer Team (IPDFUT) helps in the management of diabetes‐related foot ulcers (DFUs) in patients living in a small urban community in Ontario, Canada. Eighty‐three patients presented to the IPDFUT with 114 DFUs of average duration of 19·5 ± 2·7 weeks. Patients were 58·4 ± 1·4 years of age and 90% had type 2 diabetes, HbA1c of 8·3 ± 2·0%, with an average diabetes duration of 22·3 ± 3·4 years; in 69% of patients, 78 DFUs healed in an average duration of 7·4 ± 0·7 weeks, requiring an average of 3·8 clinic visits. Amputation of a toe led to healing in three patients (4%) and one patient required a below‐knee amputation. Six patients died and three withdrew. Adding a skilled IPDFUT that is trained to work together resulted in improved healing outcomes. The rate of healing, proportion of wounds closed and complication rate were similar if not better than the results published previously in Canada and around the world. The IPDFUT appears to be a successful model of care and could be used as a template to provide effective community care to the patients with DFU in Ontario, Canada.     

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.     

A prospective,multicentre, open‐label,single‐arm clinical trial for treatment of chronic complex diabetic foot wounds with exposed tendon and/or bone: positive clinical outcomes of viable cryopreserved human placental membrane

Complex diabetic foot ulcers (DFUs) with exposed tendon or bone remain a challenge. They are more susceptible to complications such as infection and amputation and require treatments that promote rapid development of granulation tissue and, ultimately, reepithelialisation. The clinical effectiveness of viable cryopreserved human placental membrane (vCHPM) for DFUs has been established in a level 1 trial. However, complex wounds with exposed deeper structures are typically excluded from randomised controlled clinical trials despite being common in clinical practice. We report the results of a prospective, multicentre, open‐label, single‐arm clinical trial to establish clinical outcomes when vCHPM is applied weekly to complex DFUs with exposed deep structures. Patients with type 1 or type 2 diabetes and a complex DFU extending through the dermis with evidence of exposed muscle, tendon, fascia, bone and/or joint capsule were eligible for inclusion. Of the 31 patients enrolled, 27 completed the study. The mean wound area was 14·6 cm², and mean duration was 7·5 months. For patients completing the protocol, the primary endpoint, 100% wound granulation by week 16, was met by 96·3% of patients in a mean of 6·8 weeks. Complete wound closure occurred in 59·3% (mean 9·1 weeks). The 4‐week percent area reduction was 54·3%. There were no product‐related adverse events. Four patients (13%) withdrew, two (6·5%) for non‐compliance and two (6·5%) for surgical intervention.     

Surgical debridement,maggot therapy,negative pressure wound therapy,and silver foam dressing revive hope for patients with diabetic foot ulcer: A case report

Introduction and importanceDiabetic foot ulcers (DFUs), as one of the most debilitating complications of diabetes, can lead to amputation. Treatment and management of d DFUs are among the most critical challenges for the patients and their families.Case presentationThe present case report is of a 63-year-old man with a 5-year history of uncontrolled type 2 diabetes who has had DFU for the past three years on three sites of the left external ankle in the form of two deep circular ulcers with sizes of 6 × 4 cm and 6 × 8 cm, the sole as a superficial ulcer with a size of 6 × 3 cm, and the left heel as a deep skin groove. Moreover, the left hallux was completely gangrenous. The patient's ulcers were infected with Staphylococcus aureus and multidrug-resistant Pseudomonas aeruginosa. The patient was transferred to our wound management team. DFU was treated and managed using a combination of surgical debridement, maggot therapy, the Negative Pressure Wound Therapy (NPWT), and silver foam dressing. After three months and ten days, the patient's ulcers completely healed, and he was discharged from our service with the excellent and stable condition.Clinical discussionDFUs are caused by various pathological mechanisms, the monotherapy strategy would lead to a very low level of recovery. Therefore, DFU management requires multimodal care and interdisciplinary treatment.ConclusionBased on the present case report study's clinical results, wound-care teams can use the combination therapy applied in this case report to treat refractory DFU.     

Use of an aseptically processed,dehydrated human amnion and chorion membrane improves likelihood and rate of healing in chronic diabetic foot ulcers: A prospective,randomised, multi‐centre clinical trial in 80 patients

Amnion and chorion allografts have shown great promise in healing diabetic foot ulcers (DFUs). Results from an interim analysis of 40 patients have demonstrated the accelerated healing ability of a novel aseptically processed, dehydrated human amnion and chorion allograft (dHACA). The goal of this study was to report on the full trial results of 80 patients where dHACA was compared with standard of care (SOC) in achieving wound closure in non‐healing DFUs. After a 2‐week screening period, during which patients with DFUs were unsuccessfully treated with SOC, patients were randomised to either SOC alone or SOC with dHACA applied weekly for up to 12 weeks. At 12 weeks, 85% (34/40) of the dHACA‐treated DFUs healed, compared with 33% (13/40) treated with SOC alone. Mean time to heal within 12 weeks was significantly faster for the dHACA‐ treated group compared with SOC, 37 days vs 67 days in the SOC group (P = .000006). Mean number of grafts used per healed wound during the same time period was 4.0, and mean cost of the tissue to heal a DFU was $1771. The authors concluded that aseptically processed dHACA heals DFUs significantly faster than SOC at 12 weeks.     

Erbium: Yttrium Aluminum Garnet Laser Accelerates Healing in Indolent Diabetic Foot Ulcers

The objective of the study was to evaluate the effect of the erbium:yttrium aluminum garnet (YAG) laser on diabetic foot ulcers (DFUs) that had not responded to standard care. We retrospectively evaluated 22 nonhealing DFUs that received at least 4 weeks of standard wound care, demonstrated poor healing response, and subsequently were treated with an erbium:YAG laser. We measured the percent wound area reduction (PWAR) for the 4 weeks before initiating laser therapy and the PWAR for 4 weeks after the initiation of laser therapy. Erbium:YAG laser treatment consisted of 2 components: debridement and resurfacing. The laser settings were the same for all treatments. We used the paired t test to compare pretreatment with posttreatment wound area reduction. During the 4-week period before the initiation of laser therapy, the average PWAR was –33.6%. Four weeks after initiating treatment with the erbium:YAG laser, the average PWAR was 63.4% (p = .002) and 72.7% of wounds had ≥50% PWAR. By 12 weeks, 50% of wounds had healed. Erbium:YAG laser therapy accelerated DFU healing in a cohort of patients with ulcers that had been unresponsive to standard of care therapy.     

Potential cost‐effectiveness of using adjunctive dehydrated human amnion/chorion membrane allograft in the management of non‐healing diabetic foot ulcers in the United Kingdom

The aim of this study was to estimate the cost‐effectiveness of using dehydrated human amnion/chorion membrane (dHACM) allografts (Epifix) as an adjunct to standard care, compared with standard care alone, to manage non‐healing diabetic foot ulcers (DFUs) in secondary care in the United Kingdom, from the perspective of the National Health Service (NHS). A Markov model was constructed to simulate the management of diabetic lower extremity ulcers over a period of 1 year. The model was used to estimate the cost‐effectiveness of using adjunctive dHACM, compared with standard care alone, to treat non‐healing DFUs in the United Kingdom, in terms of the incremental cost per quality‐adjusted life year (QALY) gained at 2019/2020 prices. The study estimated that at 12 months after the start of treatment, use of adjunctive dHACM instead of standard care alone is expected to lead to a 90% increase in the probability of healing, a 34% reduction in the probability of wound infection, a 57% reduction in the probability of wound recurrence, a 6% increase in the probability of avoiding an amputation, and 8% improvement in the number of QALYs. Additionally, if £4062 is spent on dHACM allografts per ulcer, then adjunctive use of dHACM instead of standard care alone is expected to lead to an incremental cost per QALY gain of £20 000. However, if the amount spent on dHACM allografts was ≤£3250 per ulcer, the 12‐month cost of managing an ulcer treated with adjunctive dHACM would break‐even with that of DFUs treated with standard care, and it would have a 0.95 probability of being cost‐effective at the £20 000 per QALY threshold. In conclusion, within the study''s limitations, and within a certain price range, adjunctive dHACM allografts afford the NHS a cost‐effective intervention for the treatment of non‐healing DFUs within secondary care among adult patients with type 1 or 2 diabetes mellitus in the United Kingdom.     

Why is it so hard to do the right thing in wound care?

“Doing the right thing” in wound care is not an easy task. Studies suggest that 3 factors determine compliance with performing basic wound care from an evidence‐based medicine perspective: complexity, cognitive effort, and the compensation system. Two models were explored to investigate compliance with basic wound care at hospital based wound centers: offloading of diabetic foot ulcers (DFUs) and compression bandaging for venous leg ulcers. Using a very large wound‐care registry it was determined that only 6% of DFU patients received the gold standard of care for offloading, i.e., total contact casting (TCC), but among those patients who received it, the average cost of treatment was half the cost of those who did not. Although inexpensive to administer, TCC is a relatively time‐consuming procedure which is poorly reimbursed. Other DFU treatments such as bilaminate skin, are more costly but are reimbursed much more generously. Thus, the reimbursement system favors the use of more expensive therapies over more economical ones. In the case of venous leg ulcers (VLUs), only 17% of patients received adequate compression. Provision of adequate compression among VLU patients has been similarly hindered by inadequate reimbursement policy. Lack of familiarity with clinical practice guidelines increases the cognitive effort for clinicians. Improving the economic model to favor the provision of effective basic care, creating easier‐to‐use products, and making clinical practice guidelines available at the point of service may make it easier to “do the right thing(s)” in wound care.