Efficacy and safety of collagen biomaterial local application in complex treatment of the diabetic foot syndrome (final results of the multicenter randomised study)

Stupin, Victor; Silina, Ekaterina; Gorskij, V A; Gorjunov, S V; Zhidkih, Sergey; Комаров, А Н; Сивков, А. С.; Gabitov, Ruslan; Zolotareva, L.S.; Sinel’nikova, T.G.; Barancevich, E R; Bogomolov, M S; KOREJBA, K.A.; Bogdanov, E A; Krivihin, V E; Bakunov, M Yu; Eliseeva, M E; Krivihin, D V

doi:10.17116/hirurgia2018691-100

Cited by 8 publications

(9 citation statements)

References 18 publications

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“…Seven studies 24,[38][39][40][41]43,45 reported on absolute wound healing at time frames ranging from 28 days 43 to 24 weeks. 39 Only two 39,41 reported statistically significant improvements in absolute wound healing with use of collagen dressings compared to a control dressing, but both studies were small (<70 participants), lacked details on baseline ulcer and participant characteristics and other aspects of usual care; thus, any positive findings should be interpreted with caution.…”

Section: Outcome: Complete Wound Healingmentioning

confidence: 99%

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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Section: Outcome: Complete Wound Healingmentioning

confidence: 99%

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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“…Four studies compared collagen only with moist wound therapy, 45,47,48,52 one study 46 used collagen-alginate, one used a calcium alginate, 51 one compared a collagen/oxidised regenerated cellulose/silver treatment with foam, 29 one the same collagen/oxidised regenerated cellulose but without silver, 54 one compared collagen with negative pressure wound therapy, 50 one compared collagen with gauze or hydrocolloid dressings 49 , and another two 51,53 alginate alone as the intervention. Of the 12 studies, nine of them 29,[45][46][47]49,[51][52][53][54] did not report a difference in wound healing or reduction in ulcer area at the end of study duration. Thus, any reported positive outcomes should be treated with caution.…”

Section: Honey or Bee Productsmentioning

confidence: 99%

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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“…Presently, one of the new approaches to the periodontal tissue regeneration is the application of a bioplastic collagen material Collost as a barrier matrix [20]. The gel form of Collost biomaterial is widely used in general surgical practice in the management of chronic wound skin defects of various etiology [21][22][23]. Application of the collagen Collost gel for gum recession treatment, especially as a scaffold in tissue-engineered constructs is considered as a promising technique.…”

Section: Experimental Investigationsmentioning

confidence: 99%

Regenerative Cell Technologies for Gingival Recession Treatment

Рубникович¹,

Denisova²,

Vladimirskaya³

et al. 2018

Sovrem Tehnol Med

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The aim of the study was to assess experimentally the possibility of using mesenchymal stem cells (MSC) and bioplastic material Collost for gingival recession treatment based on the data of morphological alterations in the tissues of pathologically transformed periodontium. Materials and Methods. Random-bred white female rats (60 specimens) were used as a model in the experiment. The operative intervention was performed in the area of incisors of the upper and lower rat jaws. Before the investigations, 1-2 ml of the adipose tissue were harvested from one specimen under sterile conditions in order to obtain allogeneic mesenchymal stem cells. All animals were divided into 5 groups (10 rats in each group) depending on the selected method of treatment: group 1-experimental gingival recession without treatment; group 2-treatment with physiological solution; group 3-experimental gingival recession treatment with 7% Collost gel; group 4-experimental gingival recession treatment with MSC; group 5-experimental gingival recession treatment with MSC and 7% Collost gel. The control group, intact rats, consisted of 10 laboratory animals with a healthy gingiva. The creation of a model of the experimental gingival recession was carried out by mechanical V-shaped excision of periodontal tissues. Results. The isolated form of 7% Collost gel (a bioplastic collagen material) serves in the process of biodegradation as a matrix for the formation of the native connective tissue, provides adhesion of the stem cells and their transformation into pro-and fibroblasts. 7% Collost gel facilitates the reduction of gingival recession and gingival pocket depth, stimulates the process of epithelization. Injections of cell transplant suspension in physiological solution activate the processes of fibroblast differon cell proliferation and cell transformation. The cell transplant suspension in the sterile bioplastic 7% Collost gel enhances the gel and stem cell effects, contributes to the elimination of the atrophic and dystrophic changes in the gums, increase of mechanical strength, reduction of gingival recession and gingival pocket depth.

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Efficacy and safety of collagen biomaterial local application in complex treatment of the diabetic foot syndrome (final results of the multicenter randomised study)

Abstract: We have proved the efficacy and safety of collagen biomaterial topical application in a diabetic foot syndrome treatment.

Cited by 8 publications

References 18 publications

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

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)

Regenerative Cell Technologies for Gingival Recession Treatment

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