Skin Substitutes for Adults With Diabetic Foot Ulcers and Venous Leg Ulcers: A Health Technology Assessment.
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ABSTRACT:
SUBMITTER: Ontario Health (Quality)
PROVIDER: S-EPMC8210978 | biostudies-literature | 2021
REPOSITORIES: biostudies-literature
Publications
Skin Substitutes for Adults With Diabetic Foot Ulcers and Venous Leg Ulcers: A Health Technology Assessment.
Ontario health technology assessment series 20210604 7
<h4>Background</h4>Wounds may be caused in a variety of ways. Some wounds are difficult to heal, such as diabetic foot ulcers and venous leg ulcers. We conducted a health technology assessment of skin substitutes for adults with neuropathic diabetic foot ulcers and venous leg ulcers, which included an evaluation of effectiveness, safety, cost-effectiveness, the budget impact of publicly funding skin substitutes, and patient preferences and values.<h4>Methods</h4>We performed a systematic literat ...[more]
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Project description: Not available
| S-EPMC9354941 | biostudies-literature
Project description:BackgroundTissue engineering is an emerging field. Novel bioengineered skin substitutes and genetically derived growth factors offer innovative approaches to reduce the burden of diabetic foot and venous leg ulcers for both patients and health care systems. However, they frequently are very costly. Based on a systematic review of the literature, this study assesses the cost-effectiveness of these growth factors and tissue-engineered artificial skin for treating chronic wounds.MethodsOn the basis of an extensive explorative search, an appropriate algorithm for a systematic database search was developed. The following databases were searched: BIOSIS Previews, CRD databases, Cochrane Library, EconLit, Embase, Medline, and Web of Science. Only completed and published trial- or model-based studies which contained a full economic evaluation of growth factors and bioengineered skin substitutes for the treatment of chronic wounds were included. Two reviewers independently undertook the assessment of study quality. The relevant studies were assessed by a modified version of the Consensus on Health Economic Criteria (CHEC) list and a published checklist for evaluating model-based economic evaluations.ResultsEleven health economic evaluations were included. Three biotechnology products were identified for which topical growth factors or bioengineered skin substitutes for the treatment of chronic leg ulceration were economically assessed: (1) Apligraf, a bilayered living human skin equivalent indicated for the treatment of diabetic foot and venous leg ulcers (five studies); (2) Dermagraft, a human fibroblast-derived dermal substitute, which is indicated only for use in the treatment of full-thickness diabetic foot ulcers (one study); (3) REGRANEX Gel, a human platelet-derived growth factor for the treatment of deep neuropathic diabetic foot ulcers (five studies). The studies considered in this review were of varying and partly low methodological quality. They calculated that due to shorter treatment periods, fewer complications and fewer inpatient episodes the initial cost of the novel biotechnology products may be offset, making the treatment cost-effective or even cost-saving. The results of most studies were sensitive to initial costs of the products and the evidence of effectiveness.ConclusionThe study results suggest that some growth factors and tissue-engineered artificial skin products feature favourable cost-effectiveness ratios in selected patient groups with chronic wounds. Despite the limitations of the studies considered, it is evident that health care providers and coverage decision makers should take not only the high cost of the biotechnology product but the total cost of care into account when deciding about the appropriate allocation of their financial resources. However, not only the cost-effectiveness but first of all the effectiveness of these novel biotechnology products deserve further research.
| S-EPMC2716319 | biostudies-literature
Project description:Diabetic foot ulcers (DFUs) represent an important clinical problem resulting in significant morbidity and mortality. Ongoing translational research studies strive to better understand molecular/cellular basis of DFU pathology that may lead to identification of novel treatment protocols. Tissue at the non-healing wound edge has been identified as one of major contributors to the DFU pathophysiology that provides important tool for translational and clinical investigations. To evaluate quality of tissue specimens and their potential use, we obtained 81 DFU specimens from 25 patients and performed histological analyses, immunohistochemistry and RNA quality assessments. We found that depth of the collected specimen is important determinant of research utility, and only specimens containing a full-thickness epidermis could be utilized for immunohistochemistry and RNA isolation. We showed that only two-thirds of collected specimens could be utilized in translational studies. This attrition rate is important for designs of future studies involving tissue specimen collection from DFU.
| S-EPMC4349347 | biostudies-literature
Project description:Diabetic foot ulcers (DFUs) are a devastating complication of diabetes. In order to identify systemic and local factors associated with DFU healing, we examined the cellular landscape of DFUs by single-cell RNA-seq analysis of foot and forearm skin specimens, as well as PBMC samples, from 10 non-diabetic subjects, and 17 diabetic patients, 11 with, and 6 without DFU. Our analysis shows enrichment of a unique inflammatory fibroblast population in DFU patients with healing wounds. The patients with healing DFUs also depicted enrichment of macrophages with M1 polarization, as opposed to more M2 macrophages in non-healing wounds. These findings were verified using Immunohistochemistry and Spatial Transcriptomics.
2021-11-01 | GSE165816 | GEO
Project description:IntroductionChronic venous insufficiency (CVI) is an anomaly of the normal functioning of the venous system caused by valvular incompetence with or without the obstruction of venous flow. This condition can affect either or both of the superficial and the deep venous systems. Venous dysfunction can even result in congenital or acquired disorders, and its complications include venous leg ulcers (VLUs). The objective of this systematic review is to determine the effectiveness of Unna boot in the treatment of wound healing of VLU by assessing the quality of the available evidence.Methods and analysisA literature search in PubMed, CINAHL, Scopus, Web of Science, Cochrane Library, BVS/BIREME, Embase, ProQuest, BDTD, Thesis and Dissertation Catalog, Sao Paulo Research Foundation/Thesis and dissertation, OPEN THESIS, A service of the US National Institute of Health, Center for Reviews and Dissemination-University of New York and SciElo published in the last 10 years, the period from January 1999 to March 2019. The review will include primary studies (original), and Controlled Trials or Observational studies (cross-sectional, case-control or longitudinal studies) with VLU. The exclusion will include leg ulceration due to different causes, such as pressure, arterial, diabetic or mixed-aetiology leg ulcers. Data synthesis will be performed using a narrative summary and quantitative analysis.Ethics and disseminationThis systematic review does not require approval by the ethics committee, as individual patient data will not be collected. Dissemination of findings will be through publications in peer-reviewed journals and/or via conference presentations.Prospero registration numberCRD42019127947.
| S-EPMC7008408 | biostudies-literature
Project description:High prevalence of non-healing chronic wounds contributes to a huge healthcare burden across the world. Early treatment interventions for non-healing wounds are vital. It was previously shown that accumulation of 15% or more of senescent cells in a chronic wound edge is an indicator that the wound is unlikely to heal. However, determining the presence of senescent cells would require invasive procedures such as tissue biopsies to be taken. In this study, we found a strong correlation between decreased collagen area and presence of senescent cells in human chronic wounds i.e. venous leg ulcer (VLU), diabetic foot ulcer (DFU) and pressure ulcer (PRU). We also report that the lowest collagen levels were found in VLU patients less than 60 years of age, with a persistent wound of > 24 months. Elevated levels of senescent cells were also found in VLU of males. Second harmonic imaging of collagen at the edge of chronic wounds with a handheld multiphoton device could be used to predict the number of senescent cells, indicating if the wound is on a healing trajectory or not. Our data support the use of collagen imaging in cutaneous wound assessment for a faster and non-invasive method to predict cellular senescence and determining wound trajectory of healing.
| S-EPMC8505655 | biostudies-literature
Project description:Nearly 70% of older adults in the U.S. report using ≥1 dietary supplements (DSs) daily. While DSs may have health benefits, there is risk for toxicity or harmful drug-supplement interactions if not taken correctly. Older adults with chronic wounds who use DSs are at increased risk of adverse drug-supplement interactions because they usually have comorbidities requiring polypharmacy management. However, no studies have evaluated DS use in this population. The aim of this retrospective pilot study was to describe DS use by a sample of older adults (n = 40) with chronic venous leg ulcers (CVLUs) who participated in a clinical trial testing the effects of fish oil supplementation on wound healing. At baseline, study personnel assisted all participants in completing an electronic questionnaire about DS use. Descriptive statistics were used to characterize the data. Twenty-five of the 40 participants (62.5%) reported taking ≥1 DS daily. On average, DS users were 65.16 years (SD = 8.51) and the majority were men (64.0%), white (68.0%), and had at least some college education (72.0%). Fifteen (60.0%) reported taking 1-2 DSs/day, and 10 (40.0%) reported taking ≥3/day. The most frequently reported DSs used were multivitamin/mineral complex (60.0%), vitamin D (36.0%), vitamin B complex (28.0%) and calcium (28.0%). Reasons for using DSs were to maintain or improve health (44.0%), improve bone density (12%), and boost the immune system (12%). Supplement users reported consuming an average of 9.12 (SD = 6.46) prescription drugs daily and 21 (84.0%) reported ≥3 chronic health conditions. In summary, DS use in this sample of chronic wound patients was high. Moreover, DS users reported using multiple prescription drugs (2-23/day) concomitantly with DSs. While older adults with CVLUs may benefit from targeted DS therapy, monitoring their DS use to reduce risk for adverse drug-supplement interactions is best practice.
| S-EPMC9036647 | biostudies-literature
Project description:To investigate the expression of miRNAs in C57 diabetic ulcer mice by Small RNA sequencing
2024-08-31 | GSE275847 | GEO
Project description:Diabetic foot ulcers (DFUs) are a serious complication of diabetes that results in significant morbidity and mortality. Mortality rates associated with the development of a DFU are estimated to be 5% in the first 12 months, and 5-year morality rates have been estimated at 42%. The standard practices in DFU management include surgical debridement, dressings to facilitate a moist wound environment and exudate control, wound off-loading, vascular assessment, and infection and glycemic control. These practices are best coordinated by a multidisciplinary diabetic foot wound clinic. Even with this comprehensive approach, there is still room for improvement in DFU outcomes. Several adjuvant therapies have been studied to reduce DFU healing times and amputation rates. We reviewed the rationale and guidelines for current standard of care practices and reviewed the evidence for the efficacy of adjuvant agents. The adjuvant therapies reviewed include the following categories: nonsurgical debridement agents, dressings and topical agents, oxygen therapies, negative pressure wound therapy, acellular bioproducts, human growth factors, energy-based therapies, and systemic therapies. Many of these agents have been found to be beneficial in improving wound healing rates, although a large proportion of the data are small, randomized controlled trials with high risks of bias.
| S-EPMC5793889 | biostudies-other
Project description:Patients with diabetes mellitus have a lifetime risk of 15% to 25% of developing diabetic foot ulcers (DFUs). DFU is associated with significant morbidity and mortality. Wound imaging systems are useful adjuncts in monitoring of wound progress. Our study aims to review existing literature on the available wound assessment and monitoring systems for DFU. This is a systematic review of articles from PubMed and Embase (1974 - March 2020). All studies related to wound assessment or monitoring systems in DFUs were included. Articles on other types of wounds, review articles, and non-English texts were excluded. Outcomes include clinical use, wound measurement statistics, hospital system integration, and other advantages and challenges. The search identified 531 articles. Seventeen full-text studies were eligible for the final analysis. Five modalities were identified: (a) computer applications or hand-held devices (n = 5), (b) mobile applications (n = 2), (c) optical imaging (n = 2), (d) spectroscopy or hyperspectral imaging (n = 4), and (e) artificial intelligence (n = 4). Most studies (n = 16) reported on wound assessment or monitoring. Only one study reported on data capturing. Two studies on the use of computer applications reported low inter-observer variability in wound measurement (inter-rater reliability >0.99, and inter-observer variability 15.9% respectively). Hand-held commercial devices demonstrated high accuracy (relative error of 2.1%-6.8%). Use of spectroscopy or hyperspectral imaging in prediction of wound healing has a sensitivity and specificity of 80% to 90% and 74%to 86%, respectively. Majority of the commercially available wound assessment systems have not been reviewed in the literature on measurement accuracy. In conclusion, most imaging systems are superior to traditional wound assessment. Wound imaging systems should be used as adjuncts in DFU monitoring.
| S-EPMC7948910 | biostudies-literature