Recalcitrant Venous Leg Ulcers Research Articles

Analysis of computed tomography venography for the diagnosis and endovascular treatment of iliac venous compression syndrome with venous leg ulcers: a retrospective study

Iliac vein compression syndrome (IVCS) is a clinical condition defined as obstruction of the iliac vein caused by chronic compression imposed by various causes. Currently, the clinical role of computed tomography venography (CTV) in the diagnosis of IVCS is unclear. Accurately diagnosing IVCS using CTV may enhance the understanding of the pathological anatomy of iliac veins, which may lead to better treatment outcomes, especially for recalcitrant venous leg ulcers (VLU). We aimed to investigate diagnostic criteria, contributing clinical factors, and stenting for IVCS with VLU in this study. CTV, digital subtraction angiography (DSV), and Doppler ultrasound (DUS) data were obtained from the medical and imaging records of 62 patients. Additionally, contributing factors and stenting for IVCS were analysed. Patients (100%) had clinical, aetiological, anatomic, or pathological C6 disease. CTV reduced the procedure time and contrast medium dose and provided more information than DSV. Risk factors for IVCS with VLU included female sex (P = 0.036) and advanced age (P = 0.014). The rate of ulcer healing was lower in the IVCS group without stent implantation (P = 0.020). Significant improvements were noted in venous clinical severity scores (P < 0.001) and chronic venous insufficiency questionnaire-20 scores (P < 0.001) after stenting for IVCS with C6 ulcers. CTV provides a more accurate diagnosis than DUS and DSV and allows detection of possible causes of IVCS. Female sex and advanced age were potential contributing factors for IVCS. Satisfactory outcomes were observed with stenting in the treatment of IVCS with C6 ulcers.

The efficacy of combined ultrasound and electric field stimulation therapy in the treatment of venous leg ulcers.

Venous leg ulcers are the most common cause of leg ulcers. The aim of this study is to assess the effect of Combined Ultrasound and Electric Field Stimulation therapies (CUSEFS) on wound surface area and pain level in patients with venous leg ulcers, utilizing a novel device (BRH-A2 from BRH Medical, Ltd). This prospective case series study, conducted by the Department of Plastic Surgery at the Yitzhak Shamir Medical Center, Israel, collected data for subjects treated with CUSEFS with the BRH-A2 device, between April 2018 and September 2019. Measurements of wound area and assessment of pain intensity using a 10-point visual analog score were recorded. At the end of the four-week period, average wound area and pain scores were included for analysis. Ten consecutive patients met the inclusion criteria. During the study period, all patients exhibited a reduction in the wound surface area. The final average wound surface area was reduced by 53.52% following the combined treatment. Eight out of the ten patients (80%) reported a reduction in pain, with an average pain level reduction of 64% throughout eight consecutive treatments. CUSEFS therapies with BRH-A2 technology is a promising treatment for venous leg ulcers. In accordance with our preliminary results, this treatment modality can aid in the reduction of wound surface area as well as reducing the pain suffered by patients from these chronic wounds. Larger multicenter studies are needed to further quantify and qualify the beneficial effect of CUSEFS in venous leg ulcers and other chronic wounds. Venous leg ulcers (VLUs) are painful wounds occurring between the knee and ankle joint, that fail to heal for a period of at least two weeks and occur in the presence of venous disease. VLUs, are the most common cause of leg ulcers, affecting approximately 5% of the general population over the age of 65. Numerous non-invasive treatment modalities have been attempted for healing chronic wounds and ulceration, however, in some instances surgery, although invasive, is the preferred option. For many years, ultrasound (US) has been used therapeutically to treat chronic ulcers. US produces biophysical effects that are significantly beneficial to the wound healing process. Electrical stimulation therapy is another treatment option which contributes to wound healing by influencing the electrochemical wound process.Combined Modulated Ultrasound and Electric Field Stimulation (CUSEFS) have been shown to improve the healing of chronic wounds. However, research has focused predominantly on objective measures of healing, while less consideration has been given to researching the subjective discomfort and the negative impact that ulceration places on the patient. The aim of this study was to assess objective and subjective factors by measuring the short-term effect of CUSEFS on the surface area of wound and on pain levels in patients with venous leg ulcers (VLUs). Our study findings demonstrate that the combined treatment was effective in initiating wound healing and reducing levels of pain in chronic, stagnant, recalcitrant venous leg ulcers.

Why Venous Leg Ulcers Have Difficulty Healing: Overview on Pathophysiology, Clinical Consequences, and Treatment.

Venous leg ulcers (VLUs) are one of the most common ulcers of the lower extremity. VLU affects many individuals worldwide, could pose a significant socioeconomic burden to the healthcare system, and has major psychological and physical impacts on the affected individual. VLU often occurs in association with post-thrombotic syndrome, advanced chronic venous disease, varicose veins, and venous hypertension. Several demographic, genetic, and environmental factors could trigger chronic venous disease with venous dilation, incompetent valves, venous reflux, and venous hypertension. Endothelial cell injury and changes in the glycocalyx, venous shear-stress, and adhesion molecules could be initiating events in VLU. Increased endothelial cell permeability and leukocyte infiltration, and increases in inflammatory cytokines, matrix metalloproteinases (MMPs), reactive oxygen and nitrogen species, iron deposition, and tissue metabolites also contribute to the pathogenesis of VLU. Treatment of VLU includes compression therapy and endovenous ablation to occlude the axial reflux. Other interventional approaches such as subfascial endoscopic perforator surgery and iliac venous stent have shown mixed results. With good wound care and compression therapy, VLU usually heals within 6 months. VLU healing involves orchestrated processes including hemostasis, inflammation, proliferation, and remodeling and the contribution of different cells including leukocytes, platelets, fibroblasts, vascular smooth muscle cells, endothelial cells, and keratinocytes as well as the release of various biomolecules including transforming growth factor-β, cytokines, chemokines, MMPs, tissue inhibitors of MMPs (TIMPs), elastase, urokinase plasminogen activator, fibrin, collagen, and albumin. Alterations in any of these physiological wound closure processes could delay VLU healing. Also, these histological and soluble biomarkers can be used for VLU diagnosis and assessment of its progression, responsiveness to healing, and prognosis. If not treated adequately, VLU could progress to non-healed or granulating VLU, causing physical immobility, reduced quality of life, cellulitis, severe infections, osteomyelitis, and neoplastic transformation. Recalcitrant VLU shows prolonged healing time with advanced age, obesity, nutritional deficiencies, colder temperature, preexisting venous disease, deep venous thrombosis, and larger wound area. VLU also has a high, 50–70% recurrence rate, likely due to noncompliance with compression therapy, failure of surgical procedures, incorrect ulcer diagnosis, progression of venous disease, and poorly understood pathophysiology. Understanding the molecular pathways underlying VLU has led to new lines of therapy with significant promise including biologics such as bilayer living skin construct, fibroblast derivatives, and extracellular matrices and non-biologic products such as poly-N-acetyl glucosamine, human placental membranes amnion/chorion allografts, ACT1 peptide inhibitor of connexin 43, sulodexide, growth factors, silver dressings, MMP inhibitors, and modulators of reactive oxygen and nitrogen species, the immune response and tissue metabolites. Preventive measures including compression therapy and venotonics could also reduce the risk of progression to chronic venous insufficiency and VLU in susceptible individuals.

Compression Therapy Is Not Contraindicated in Diabetic Patients with Venous or Mixed Leg Ulcer.

The aim of this study was to investigate if compression therapy (CT) can be safely applied in diabetic patients with Venous Leg Ulcers (VLU), even when a moderate arterial impairment (defined by an Ankle-Brachial Pressure Index 0.5–0.8) occurs as in mixed leg ulcers (MLU). Materials and methods: in one of our previous publications we compared the outcomes of two groups of patients with recalcitrant leg ulcers. Seventy-one patients were affected by mixed venous and arterial impairment and 109 by isolated venous disease. Both groups were treated by tailored inelastic CT (with compression pressure <40 mm Hg in patients with MLU and >60 mm Hg in patients with VLU) and ultrasound guided foam sclerotherapy (UGFS) of the superficial incompetent veins with the reflux directed to the ulcer bed. In the present sub analysis of the same patients we compared the healing time of 107 non-diabetic patients (NDP), 69 with VLU and 38 with MLU) with the healing time of 73 diabetic patients (DP), 40 with VLU and 33 with MLU. Results: Twenty-five patients were lost at follow up. The results refer to 155 patients who completed the treatment protocol. In the VLU group median healing time was 25 weeks for NDP and 28 weeks in DP (p = 0.09). In the MLU group median healing time was 27 weeks for NDP and 29 weeks for DP (p = −0.19). Conclusions: when providing leg ulcer treatment by means of tailored compression regimen and foam sclerotherapy for superficial venous refluxes, diabetes has only a minor or no effect on the healing time of recalcitrant VLU or MLU.

Recalcitrant Venous Leg Ulcers May Heal by Outpatient Treatment of Venous Disease Even in the Presence of Concomitant Arterial Occlusive Disease

Recalcitrant Venous Leg Ulcers May Heal by Outpatient Treatment of Venous Disease Even in the Presence of Concomitant Arterial Occlusive Disease

Recalcitrant Venous Leg Ulcers May Heal by Outpatient Treatment of Venous Disease Even in the Presence of Concomitant Arterial Occlusive Disease

Peripheral arterial occlusive disease (PAOD) is reported in about 15-20% of patients with venous leg ulcers (VLU). In such cases arterial recanalization is often recommended, and compression therapy is considered a contraindication when the ankle brachial pressure index (ABPI) is<0.8. The aim of this study was to compare the outcome of patients with recalcitrant VLU, both without any arterial impairment ("pure venous recalcitrant leg ulcer" [pvRLU]) and with associated PAOD ("mixed arterial and venous recalcitrant leg ulcer" [mavRLU]), by treating only the venous disease. The records of 180 outpatients with recalcitrant ulcers treated between January 2011 and July 2014 were reviewed retrospectively. In total, 109 were affected by pvRLU and 71 by mavRLU, with moderate PAOD defined by an ABPI between 0.5 and 0.8. In addition to the same local wound dressing, the patients received ultrasound guided foam sclerotherapy of the refluxing superficial veins and a modified inelastic compression with a pressure ≤ 40mmHg. No patient was referred for arterial revascularization. The patients were followed until ulcer healing. Patients with pvRLU and mavRLU showed comparable demographic characteristics. Twenty-five patients were lost to follow up and the outcomes were analyzed in 93 patients with pVLU (85.4%) and in 62 patients with mavRLU (87.4%). The maximum time to complete healing was 48 weeks in the pvRLU group and 52 weeks in the mavRLU group (p=.009), The median healing time was 23 (pvRLU) versus 25.5 weeks (mavRLU) (p=.030). Deep venous incompetence (p<.001), ulcer surface area (p<.001), arterial disease (p=.002), and ulcer duration (p<.010) were risk factors for prolonged healing. Treatment of recalcitrant leg ulcers by treating venous incompetence by foam sclerotherapy and modified compression is successful, even if underlying moderate PAOD is not actively treated.

The recalcitrant venous leg ulcer – a never ending story?

SummaryIntroduction: In general, four particular causes of recalcitrant venous leg ulcers may be distinguished. These are foot pump insufficiency, chronic venous compartment syndrome and non-re-canalized popliteal vein thrombosis. The fourth cause of recalcitrant venous leg ulcers is lipodermatosclerosis as a symptom of severe chronic venous insufficiency.Methods: We reviewed the literature and based on this we describe four main causes of recalcitrant venous leg ulcers and their specific treatment.Results: Foot pump insufficiency arises when the plantar foot veins are not able to empty. Treatment should consist of physical therapy, a mechanical foot pump device and an insole. Lipodermatosclerosis may be treated by excision and split-thickness skin grafting (Vigoni procedure). Chronic venous compartment syndrome is usually caused by post-thrombotic syndrome and treatment consists of a fasciectomy, but is rarely used nowadays. Patients with non-re-canalized popliteal vein thrombosis may be supported by intermittent pneumatic compression, walking exercises, alternate standing and walking with lying down. All patients with recalcitrant venous leg ulcers must wear medical elastic compression stockings with high stiffness and high compression lifelong.Conclusions: Patients with recalcitrant venous leg ulceration are challenging. More specific treatment will heal more of these ulcers.

Ulcer recurrence after in-hospital treatment for recalcitrant venous leg ulceration

Leg ulceration caused by chronic venous disease occurs in 1% of the adult Western population. A majority of these patients is successfully treated in the outpatient setting. A minority of patients is hospitalized, most frequently because of the lack of healing tendency. The literature provides recurrence rates for ulcer disease, but lacks specific data on recurrence rates after in-hospital treatment of recalcitrant venous leg ulcers. To investigate time to ulcer recurrence after in-hospital treatment of venous leg ulceration. A multicentre, retrospective cohort study of patients admitted for leg ulceration between 1996 and 2007 was conducted. Data could be collected for 107 of the patients. Of these, 27 had conservative treatment (bed rest, local wound care, pain management) and 48 patients underwent surgical ulcer treatment with (n = 19) or without (n = 29) initial vacuum-assisted closure (VAC) treatment. The treatment method was 'miscellaneous' in the remaining 32 patients. Median admission time was 30 days, median percentage of closure at discharge was 95%, and median time to ulcer recurrence 60 days. The Mann-Whitney U-test showed significant differences between the conservative group and the surgery group, the latter having a longer length of hospital stay (P < 0.0001) and a higher percentage of ulcer closure (P < 0.0001), but there was no difference in time to ulcer recurrence (P = 0.273). Comparable differences were demonstrated between the conservative group and the VAC plus surgery group. No significant differences could be demonstrated between the surgically treated patients and those treated by VAC and surgery. Hospital stay is significantly shorter in cases of surgical treatment of recalcitrant venous leg ulcers. Most ulcers recur within 2 months after hospital discharge. Recurrence of venous leg ulcers after hospital admission is independent of the method of treatment and cause of ulceration.

Clinical and cost-effectiveness of absorbent dressings in the treatment of highly exuding VLUs

Journal of Wound CareVol. 22, No. Sup3 Clinical and cost-effectiveness of absorbent dressings in the treatment of highly exuding VLUsM. Panca, , K. Cutting, and J.F. GuestM. PancaCatalyst Health Economics Consultants, Middlesex, UKSearch for more papers by this author, , K. CuttingCatalyst Health Economics Consultants, Middlesex, UKSearch for more papers by this author, and J.F. GuestCatalyst Health Economics Consultants, Middlesex, UKSchool of Biomedical Sciences, King's College, London, UKSearch for more papers by this authorM. Panca; K. Cutting; J.F. GuestPublished Online:1 Jul 2014https://doi.org/10.12968/jowc.2013.22.Sup3.S3AboutSectionsView articleView Full TextPDF/EPUB ToolsAdd to favoritesDownload CitationsTrack CitationsPermissions ShareShare onFacebookTwitterLinked InEmail View article References 1 White R., Cutting K., Modern exudate management: a review of wound treatments. World Wide Wounds. 2006; Available from: http://tinyurl.com/6ccfloz [Accessed February 2013]. 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Link, Google Scholar FiguresReferencesRelatedDetailsCited byA Systematic Review of Model-Based Economic Evaluations of Treatments for Venous Leg Ulcers27 May 2019 | PharmacoEconomics - Open, Vol. 4, No. 2Environmental Remediation of Chlorinated Hydrocarbons Using Biopolymer Stabilized Iron Loaded Halloysite Nanotubes24 October 2017 | ACS Sustainable Chemistry & Engineering, Vol. 5, No. 11 1 March 2013Volume 22Issue Sup3ISSN (print): 0969-0700ISSN (online): 2052-2916 Metrics History Published online 1 July 2014 Published in print 1 March 2013 Information© MA Healthcare LimitedPDF download

Modelling the relative cost-effectiveness of amelogenin in non-healing venous leg ulcers

To assess the cost-effectiveness of using amelogenin plus compression bandaging versus compression bandaging alone in treating non-healing venous leg ulcers (VLUs) of over six months duration, from the perspective of the national health service in England. A 12-month Markov model was constructed that depicted the management of a chronic, non-healing VLU of over six months duration. The model considers the decision by a clinician to treat a recalcitrant VLU with amelogenin plus compression bandaging or compression bandaging alone, and was used to estimate the relative cost-effectiveness of amelogenin plus compression bandaging at 20062007 prices. According to the model, 60% of all wounds treated with amelogenin plus compression bandaging are expected to heal within 12 months of the start of treatment compared with 41% of wounds treated with compression bandaging alone (p<0.01). Additionally, 23% of all amelogenin-treated wounds are expected to improve compared with 18% of wounds in the compression bandaging alone group. This difference in effectiveness between the two groups is expected to lead to a 7% improvement in health gain among amelogenin-treated patients when compared with those treated with compression bandaging alone (0.800 versus 0.746 QALYs; p<0.01) at 12 months after the start of treatment. Use of amelogenin is expected to lead a 10% reduction in NHS cost over 12 months from pound4,261 (95% CI: pound3,409; pound5,114) to pound3,816 (95% CI: pound3,227; pound4,405), due in part to a reduction in the requirement for nurse visits. Hence, amelogenin plus compression bandaging was found to be a dominant treatment. Moreover, use of amelogenin is expected to free-up NHS resources for alternative use within the system. Within the models limitations, amelogenin plus compression bandaging is expected to afford the NHS a cost-effective dressing compared with compression bandaging alone in the management of chronic non-healing VLUs of more than six months duration. This study was sponsored by Mölnlycke Heath Care. The authors have no other conflicts of interest that are directly relevant to the content of this manuscript.

Tumor necrosis factor–alfa in nonhealing venous leg ulcers

Venous leg ulcers are responsible for more than half of all lower extremity ulcerations, affecting more than one million Americans annually. Studies have demonstrated alterations in levels of proinflammatory cytokines in patients with chronic wounds, including tumor necrosis factor-alfa (TNFalpha), which may be implicated in wound chronicity. To test the hypothesis that recalcitrant venous leg ulcers have increased local tissue TNFalpha as compared to normal skin. Five patients with nonhealing healing chronic venous leg ulcers were recruited. Two 4-mm punch biopsy specimens were obtained: one from the wound margin and one from noninvolved, non-sun exposed normal skin on the flexor aspect of the forearm. Tissue samples were processed using fixed with formalin stained by immunohistochemistry for TNFalpha. Qualitative and quantitative comparisons were made for the presence of TNFalpha receptor in all tissue samples, specifically comparing the presence of TNFalpha in nonhealing venous leg ulcer samples versus normal skin. The overall staining score for nonhealing venous leg ulcers was significantly higher compared to respective normal skin samples (P = .01). In addition, immunostaining for TNFalpha was significantly less in the two nonhealing venous leg ulcers that were present for the shortest duration compared to the other ulcers of longer duration (P = .048). The small sample size may mitigate the clinical implications of findings. Increased levels of TNFalpha in nonhealing venous leg ulcers, especially those of longer duration, implies that excessive inflammation may be causal in wound chronicity and suggests potential therapeutic alternatives.

Managing chronic venous leg ulcers with zinc oxide paste bandages

Chronic venous leg ulcers are a major problem for patients as they affect the quality of life in terms of their ability to work, self-esteem and daily activities of living. It is therefore imperative for practitioners to plan interventions based on the current best evidence available for the treatment of venous leg ulcers. Currently, the best practice recommended for the management of chronic venous leg ulcers is compression bandaging. However, this therapy has not been successful in a minority of patients as they have continued to suffer physical and psychological problems as a result of ulcers that fail to heal. This article discusses the management of patients suffering from recalcitrant venous leg ulcers with the use of zinc impregnated paste bandages as a primary dressing. These case studies have shown that wound healing can be achieved when using zinc oxide paste bandages (Viscopaste PB7) as a primary dressing in the management of difficult to heal venous leg ulcers.

Treatment of recalcitrant venous leg ulcers with autologous keratinocytes in fibrin sealant: A multinational randomized controlled clinical trial

In a multicenter trial, the effect of a commercially available combination of autologous keratinocytes (3-6 x 10(6)/mL) with fibrin sealant (Tissucol Duo S Immuno, Baxter Hyland Immuno) on the healing of recalcitrant venous leg ulcers (duration >3 months) was compared with standard care. The primary endpoint was time to healing, and the secondary endpoint was number of healed ulcers in both groups. Both groups received compression therapy with short-stretch bandages. Forty-four (38.3%) of the 116 patients who had BioSeed-S treatment achieved complete healing of the target ulcer compared with 24 (22.4%) of 109 patients who received standard treatment. The advantage for treatment with BioSeed-S over standard treatment was statistically significant (chi-square test: p=0.0106). Time to complete healing of ulcers: the log-rank test for equality over strata revealed a superiority of treatment with BioSeed-S+compression (median: 176 days) over compression+standard care (median >201 days) (p<0.0001). This study, to date the largest multicenter study with autologous keratinocytes, provides evidence for its efficacy in the treatment of patients with therapy-resistant chronic venous leg ulcers.

Evaluation of hypochlorous acid washes in the treatment of chronic venous leg ulcers.

Hypochlorous acid (HOCl) is a highly microbiocidal agent active against bacteria, viruses and fungi. Using quantitative microbiology, preliminary studies showed it achieved an appreciable reduction in the bacterial burden in chronic venous leg ulcers. The study aimed to determine whether it has a role as an additional treatment for chronic venous ulcers that have not healed with conventional treatment. On the basis of previous reports we designed a study in which patients acted as their own controls, in that only patients who failed to achieve a 44% reduction in wound size with standard treatment (compression bandaging) received HOCl washes. Of 30 patients admitted to the study, 10 achieved a 44% ulcer reduction after three weeks of standard treatment. In addition to the standard compression treatment, the remaining 20 patients were given HOCl washes over 12 weeks. Of the 20 ulcers, nine (45%) healed and five (25%) reduced in size by over 60%. All patients became free of pain. These findings confirm the clinical efficacy of treating venous leg ulcers with hypochlorous washes. Use of HOCl washes as an adjunctive therapy for recalcitrant venous leg ulcers appreciably increases healing and rapidly relieves pain.