A parallel open-label trial to evaluate microbial cellulose wound dressing in the treatment of diabetic foot ulcers

Objectives: Perfusion and blood oxygen levels are frequently insufficient in patients with hard-to-heal wounds due to poor circulation, vascular disruption and vasoconstriction, reducing the wound's capacity to heal. This study aimed to investigate the effect of topical oxygen on healing rates in patients with hard-to-heal diabetic foot ulcers (DFUs) (i.e., non-responsive over four weeks). Method: This multicentre, open-label, community-based randomised clinical trial compared standard care (SOC) with or without continuous topical oxygen therapy (TOT) for 12 weeks in patients with DFUs or minor amputation wounds. SOC included debridement, offloading with total contact casting (TCC) and appropriate moisture balance. Primary endpoints were the number of patients to achieve complete wound closure and percentage change in ulcer size. Secondary endpoints were pain levels and adverse events. Results: For the study, 145 patients were randomised with index ulcers graded Infectious Diseases Society of America (IDSA) 1 or 2, or Wagner 1 or 2. In the intention-to-treat analysis, 18/64 (28.1%) patients healed in the SOC group at 12 weeks compared with 36/81 (44.4%) in the SOC plus TOT group (p=0.044). There was a statistically significant reduction in wound area between the groups: SOC group mean reduction: 40% (standard deviation (SD) 72.1); SOC plus TOT group mean reduction: 70% (SD 45.5); per protocol p=0.005). There were no significant differences in changes to pain levels or adverse events. Conclusion: This study suggests that the addition of TOT to SOC facilitates wound closure in patients with hard-to-heal DFUs.

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Blind Comparative study between Silver nanoparticles dressings and Standard Moist Wound Dressings (SMWD) in management of diabetic foot ulcers

QJM ◽

10.1093/qjmed/hcab097.040 ◽

2021 ◽

Vol 114 (Supplement_1) ◽

Author(s):

Amr Abdelaal ◽

Mostafa Soliman ◽

Hany Rafik ◽

Mohamed Emam ◽

Mohamed Mahmoud Mohamed Elsadek

Keyword(s):

Silver Nanoparticles ◽

Diabetic Foot ◽

Wound Dressing ◽

Treatment Modalities ◽

Controlled Study ◽

Foot Ulcers ◽

Diabetic Patients ◽

Diabetic Foot Ulcers ◽

Group A ◽

Group B

Abstract Background Diabetic foot ulcers (DFUs) are the main cause of hospitalization in diabetic patients and they are considered a major worldwide health problem. Thus, there is a need to evaluate various treatment modalities. In this study we will assess the clinical efficacy of Silver nanoparticles dressing vs Standard Moist Wound Dressing (SMWD) in management of diabetic foot ulcers. Objective To compare wound outcome, limb salvage, healing time of diabetes related foot ulcers and cost effectiveness in terms of duration of hospital stay between Silver nanotechnology dressings and Standard moist wound therapy (SMWT) in management of diabetic foot ulcers. Patients and Methods This is a prospective randomized controlled study involving 34 patients with active diabetic foot ulcers, in a high volume tertiary referral vascular center. They were divided into 2 groups: 17 patients (group A) were prescribed SMWD and the other 17 patients (group B) received Silver nanoparticles wound dressing. Results Our study correlates with the study conducted by K.Suhas et al. which had observed that Silver nanoparticles wound dressing was safe and effective treatment for complex diabetic foot wounds and could lead to higher proportion of healed wounds and faster healing rates. At the end of the study, group B promised a better outcome as compared to group A. Conclusion The role of Silver nanoparticles wound dressing in healing of diabetic foot ulcers has been proposed as a novel method of manipulating the chronic wound environment in a way that it reduces bacterial burden and chronic interstitial wound fluid, increases vascularity and cytokine expression and to an extent mechanically exploiting the viscoelasticity of peri wound tissues.

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Evaluation of Polyvinyl Alcohol/Cobalt Substituted Hydroxyapatite Nanocomposite as a Potential Wound Dressing for Diabetic Foot Ulcers

International Journal of Molecular Sciences ◽

10.3390/ijms21228831 ◽

2020 ◽

Vol 21 (22) ◽

pp. 8831

Author(s):

Wei-Chun Lin ◽

Cheng-Ming Tang

Keyword(s):

Polyvinyl Alcohol ◽

Diabetic Foot ◽

Wound Dressing ◽

Foot Ulcers ◽

Diabetic Foot Ulcers ◽

E Coli ◽

Accelerate Wound Healing ◽

Persistent Infections ◽

Electrochemically Deposited ◽

Potential Applications

Diabetic foot ulcers (DFUs) caused by diabetes are prone to serious and persistent infections. If not treated properly, it will cause tissue necrosis or septicemia due to peripheral blood vessel embolism. Therefore, it is an urgent challenge to accelerate wound healing and reduce the risk of bacterial infection in patients. In clinical practice, DFUs mostly use hydrogel dressing to cover the surface of the affected area as an auxiliary treatment. Polyvinyl alcohol (PVA) is a hydrophilic hydrogel polymer widely used in dressings, drug delivery, and medical applications. However, due to its weak bioactivity and antibacterial ability, leads to limited application. Filler adding is a useful way to enhance the biocompatibility of PVA. In our study, cobalt-substituted hydroxyapatite (CoHA) powder was prepared by the electrochemically-deposited method. PVA and PVA-CoHA nanocomposite were prepared by the solvent casting method. The bioactivity of the PVA and composite was evaluated by immersed in simulated body fluid for 7 days. In addition, L929 cells and E. coli were used to evaluate the cytotoxicity and antibacterial tests of PVA and PVA-CoHA nanocomposite. The results show that the addition of CoHA increases the mechanical properties and biological activity of PVA. Biocompatibility evaluation showed no significant cytotoxicity of PVA-CoHA composite. In addition, a small amount of cobalt ion was released to the culture medium from the nanocomposite in the cell culture period and enhanced cell growth. The addition of CoHA also confirmed that it could inhibit the growth of E. coli. PVA-CoHA composite may have potential applications in diabetic trauma healing and wound dressing.

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Spray on skin for diabetic foot ulcers: an open label randomised controlled trial

Journal of Foot and Ankle Research ◽

10.1186/s13047-019-0362-x ◽

2019 ◽

Vol 12 (1) ◽

Author(s):

Laurens Manning ◽

Emma J. Hamilton ◽

Edward Raby ◽

Paul E. Norman ◽

Wendy Davis ◽

...

Keyword(s):

Quality Of Life ◽

Wound Healing ◽

Diabetic Foot ◽

Controlled Trial ◽

Economic Benefits ◽

Complete Healing ◽

Foot Ulcers ◽

Diabetic Foot Ulcers ◽

Open Label

Abstract Background One Australian loses a limb every 3 h as a result of infected diabetic foot ulcers (DFU). This common condition accounts for substantial morbidity and mortality for affected individuals and heavy economic costs for the health sector and the community. There is an urgent need to test interventions that improve wound healing time, prevent amputations and recurrent ulceration in patients presenting with DFU whilst improving quality of life and reducing health care costs. Methods One hundred and fifty eligible participants will be randomised to receive an autologous skin cell suspension, also termed ‘spray-on’ skin (ReCell®) or standard care interventions for their DFU. The primary outcome is complete wound healing at 6 months, but participants will be followed up for a total of 12 months to enable secondary outcomes including total overall costs, ulcer free days at 12 months and quality of life to be assessed. Discussion Outpatient costs for dressings, home nursing visits and outpatient appointments are key cost drivers for DFU. If spray-on skin is effective, large cost savings to WA Health will be realised immediately through a shortened time to healing, and through a higher proportion of patients achieving complete healing. Shortened healing times may enable participants to return to work earlier. Any economic benefits are likely to be amplified across Australia and other similar demographic settings where aging populations with increased diabetes rates are considered major future challenges. Trial registration Australian New Zealand Clinical Trials Registry ACTRN12618000511235. Registered on 9 April 2018.

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Open, non-comparative, multi-centre post clinical study of the performance and safety of a gelling fibre wound dressing on diabetic foot ulcers

Journal of Wound Care ◽

10.12968/jowc.2016.25.5.290 ◽

2016 ◽

Vol 25 (5) ◽

pp. 290-300 ◽

Cited By ~ 2

Author(s):

P. Chadwick ◽

J. McCardle

Keyword(s):

Clinical Study ◽

Diabetic Foot ◽

Wound Dressing ◽

Foot Ulcers ◽

Diabetic Foot Ulcers

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Evaluation of the safety and healing potential of a fibroin-aloe gel film for the treatment of diabetic foot ulcers

Journal of Wound Care ◽

10.12968/jowc.2021.30.12.1020 ◽

2021 ◽

Vol 30 (12) ◽

pp. 1020-1028

Author(s):

Saran Worasakwutiphong ◽

Tanapron Termwattanaphakdee ◽

Thanpawee Kamolhan ◽

Preeyawass Phimnuan ◽

Anuphan Sittichokechaiwut ◽

...

Keyword(s):

Porous Structure ◽

Diabetic Foot ◽

Wound Dressing ◽

Foot Ulcers ◽

Diabetic Foot Ulcers ◽

Swelling Ratio ◽

Wound Area ◽

Area Reduction ◽

Gel Film ◽

Aloe Gel

Objective: This study aimed to develop a wound dressing prepared from the blending of silkworm fibroin and aloe gel extract for use in the treatment of diabetic foot ulcers (DFUs). Methods: Fibroin extracted from silkworm cocoons and aloe gel extract were dissolved in deionised water. pH levels were then adjusted with lactic acid solution. A simple casting technique was used to obtain the fibroin–aloe gel film. The surface morphology, hardness, flexibility and infrared spectrum of the sterilised film were tested. Swelling ratio was measured from changes in weight. The cytocompatibility of the film to human dermal fibroblast was determined using XTT assay. Hard-to-heal DFUs (grade I Wagner score) were treated with the film for four weeks. The application site was assessed for allergic reactions and/or sensitisation. Wound size was measured using standardised digital photography. Results: A total of five hard-to-heal DFUs were treated. The obtained film sterilised with ozonation showed a non-porous structure. The elongation at break and tensile strength of the wet film were 9.00±0.95% and 6.89±1.21N, respectively. Fourier-transform infrared spectroscopy data indicated the presence of amides I, II and III, of peptide linkage, which are the chemical characteristics of the fibroin. Functional groups relating to healing activity of the aloe gel extract were also found. The swelling ratio of the film immersed in water for 24 hours was 0.8±0.01. In three DFUs (40–50mm2 in size), a wound area reduction of 0.4–0.8mm2/day was observed and were healed in 2–3 weeks. The remaining two SFUs (500mm2 in size) showed a wound area reduction of 4mm2/day and were almost closed at four weeks. No allergic reaction or infection was observed in any of the wounds. Conclusion: The obtained film showed a non-porous structure, and its strength and flexibility were adequate for storage and handling. The film tended to increase the proliferation of fibroblasts. The wound dressing showed potential for accelerating the healing rate of DFUs.

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