The effectiveness of a new dried human amnion derived membrane in addition to standard care in treating diabetic foot ulcers: A patient and assessor blind, randomised controlled pilot study

Game, Frances; Gray, Katie; Davis, Daniel G.; Sherman, Rachelle; Chokkalingam, Kamal; Connan, Zak; Fakis, Apostolos; Jones, Michael A.

doi:10.1111/iwj.13571

Cited by 10 publications

(18 citation statements)

References 15 publications

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“…A multicenter, double‐blinded RCT demonstrated that human amniotic membrane preparation is safe and promising for DF treatment. 36 Amniotic membrane allografts could facilitate wound closure with standard therapy in chronic ulcers that are resistant to closure, 37 which indicates that amniotic membrane allografts are promising for improving wound healing. Various modalities such as human amniotic membrane preparations, growth factors, stem cells, cultured fibroblasts, keratinocytes were applied to treat difficult‐to‐heal ulcers.…”

Section: Resultsmentioning

confidence: 99%

“…Recent co‐cited references focused on foot ulcers, amniotic membrane, osteomyelitis, and diabetic wound healing. A multicenter, double‐blinded RCT demonstrated that human amniotic membrane preparation is safe and promising for DF treatment 36 . Amniotic membrane allografts could facilitate wound closure with standard therapy in chronic ulcers that are resistant to closure, 37 which indicates that amniotic membrane allografts are promising for improving wound healing.…”

Section: Resultsmentioning

confidence: 99%

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A scientometrics analysis and visualisation of diabetic foot research from 1955 to 2022

Shen

Chen

Feng

et al. 2022

International Wound Journal

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Diabetic foot (DF) has become a serious health problem in modern society, and it has been a hotspot of research for a long time. However, little scientometric analysis has been carried out on DF. In the present study, we analysed 8633 literature reports on DF in the Web of Science Core Collection from database inception until April 23, 2022. VOSviewer (Centre for Science and Technology Studies at Leiden University, Leiden, the Netherlands) and CiteSpace (College of Computing and Informatics, Drexel University, Philadelphia, United States) were employed to address high‐impact countries and institutions, journals, references, research hotspots, and key research fields in DF research. Our analysis findings indicated that publications on DF have increased markedly since 2016 and were primarily published in the United States of America. The recent studies focus on the amniotic membrane, foot ulcers, osteomyelitis, and diabetic wound healing. The five keyword clusters, which included DF ulcer and wound healing therapies, management and guidelines, neuropathy and plantar pressure, amputation and ischemia, and DF infection and osteomyelitis, are helpful for enhancing prevention, standardising treatment, avoiding complications, and improving prognosis. These findings indicated a method for future therapies and research in DF.

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Section: Resultsmentioning

confidence: 99%

Section: Resultsmentioning

confidence: 99%

A scientometrics analysis and visualisation of diabetic foot research from 1955 to 2022

Shen

Chen

Feng

et al. 2022

International Wound Journal

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“…We identified 10 studies of placental-derived products, 163,216,[229][230][231][232][233][234][235][236] which between them included a total of 886 participants.…”

Section: Placental Derived Productsmentioning

confidence: 99%

“…Of these, one described the use of dehydrated amnion/ chorion graft, 234 six the use of dehydrated human amniotic membrane (dHAM), 163,229,231,232,235,236 with one the use of cryopreserved placental membrane, 230 one the use of dehydrated human umbilical cord, 233 and one powdered dehydrated amniotic membrane. 216 Outcome: complete wound healing.…”

Section: Placental Derived Productsmentioning

confidence: 99%

“…However, only one of these was at low risk of bias but was too small (as a pilot trial) to draw any conclusions. 236 The study with a cryopreserved amniotic membrane product 230 , which was considered at uncertain risk of bias, reported a significant difference in those ulcers achieving a 50% area reduction at 4 weeks (of a 12 weeks study). One 3-way study of an application of dried powdered amniotic membrane versus platelet derived growth factor versus usual care 216 only reported wound area reduction.…”

Section: Placental Derived Productsmentioning

confidence: 99%

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Effectiveness of interventions to enhance healing of chronic foot ulcers in diabetes: A systematic review

Chen,

Vilorio,

Dhatariya

et al. 2024

Diabetes Metabolism Res

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BackgroundIt is critical that interventions used to enhance the healing of chronic foot ulcers in diabetes are backed by high‐quality evidence and cost‐effectiveness. In previous years, the systematic review accompanying guidelines published by the International Working Group of the Diabetic Foot performed 4‐yearly updates of previous searches, including trials of prospective, cross‐sectional and case‐control design.AimsDue to a need to re‐evaluate older studies against newer standards of reporting and assessment of risk of bias, we performed a whole new search from conception, but limiting studies to randomised control trials only.Materials and MethodsFor this systematic review, we searched PubMed, Scopus and Web of Science databases for published studies on randomised control trials of interventions to enhance healing of diabetes‐related foot ulcers. We only included trials comparing interventions to standard of care. Two independent reviewers selected articles for inclusion and assessed relevant outcomes as well as methodological quality.ResultsThe literature search identified 22,250 articles, of which 262 were selected for full text review across 10 categories of interventions. Overall, the certainty of evidence for a majority of wound healing interventions was low or very low, with moderate evidence existing for two interventions (sucrose‐octasulfate and leucocyte, platelet and fibrin patch) and low quality evidence for a further four (hyperbaric oxygen, topical oxygen, placental derived products and negative pressure wound therapy). The majority of interventions had insufficient evidence.ConclusionOverall, the evidence to support any other intervention to enhance wound healing is lacking and further high‐quality randomised control trials are encouraged.

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Guidelines on interventions to enhance healing of foot ulcers in people with diabetes (IWGDF 2023 update)

Chen,

Vilorio,

Dhatariya

et al. 2023

Diabetes Metabolism Res

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AimsPrinciples of wound management, including debridement, wound bed preparation, and newer technologies involving alternation of wound physiology to facilitate healing, are of utmost importance when attempting to heal a chronic diabetes‐related foot ulcer. However, the rising incidence and costs of diabetes‐related foot ulcer management necessitate that interventions to enhance wound healing of chronic diabetes‐related foot ulcers are supported by high‐quality evidence of efficacy and cost effectiveness when used in conjunction with established aspects of gold‐standard multidisciplinary care. This is the 2023 International Working Group on the Diabetic Foot (IWGDF) evidence‐based guideline on wound healing interventions to promote healing of foot ulcers in persons with diabetes. It serves as an update of the 2019 IWGDF guideline.Materials and MethodsWe followed the GRADE approach by devising clinical questions and important outcomes in the Patient‐Intervention‐Control‐Outcome (PICO) format, undertaking a systematic review, developing summary of judgements tables, and writing recommendations and rationale for each question. Each recommendation is based on the evidence found in the systematic review and, using the GRADE summary of judgement items, including desirable and undesirable effects, certainty of evidence, patient values, resources required, cost effectiveness, equity, feasibility, and acceptability, we formulated recommendations that were agreed by the authors and reviewed by independent experts and stakeholders.ResultsFrom the results of the systematic review and evidence‐to‐decision making process, we were able to make 29 separate recommendations. We made a number of conditional supportive recommendations for the use of interventions to improve healing of foot ulcers in people with diabetes. These include the use of sucrose octasulfate dressings, the use of negative pressure wound therapies for post‐operative wounds, the use of placental‐derived products, the use of the autologous leucocyte/platelet/fibrin patch, the use of topical oxygen therapy, and the use of hyperbaric oxygen. Although in all cases it was stressed that these should be used where best standard of care was not able to heal the wound alone and where resources were available for the interventions.ConclusionsThese wound healing recommendations should support improved outcomes for people with diabetes and ulcers of the foot, and we hope that widescale implementation will follow. However, although the certainty of much of the evidence on which to base the recommendations is improving, it remains poor overall. We encourage not more, but better quality trials including those with a health economic analysis, into this area.

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The effectiveness of a new dried human amnion derived membrane in addition to standard care in treating diabetic foot ulcers: A patient and assessor blind, randomised controlled pilot study

Cited by 10 publications

References 15 publications

A scientometrics analysis and visualisation of diabetic foot research from 1955 to 2022

A scientometrics analysis and visualisation of diabetic foot research from 1955 to 2022

Effectiveness of interventions to enhance healing of chronic foot ulcers in diabetes: A systematic review

Guidelines on interventions to enhance healing of foot ulcers in people with diabetes (IWGDF 2023 update)

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