Foam and Hydrogel dressing for diabetic foot ulcers

NewsBot · Sep 9, 2011

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Hydrogel dressings for healing diabetic foot ulcers.
Dumville JC, O'Meara S, Deshpande S, Speak K.
Cochrane Database Syst Rev. 2011 Sep 7;9:CD009101.

BACKGROUND:
Foot ulcers in people with diabetes are a prevalent and serious global health issue. Dressings form a key part of ulcer treatment, with clinicians and patients having many different types to choose from including hydrogel dressings. A clear and current overview of current evidence is required to facilitate decision-making regarding dressing use.

OBJECTIVES:
To assess the effects of hydrogel wound dressings compared with alternative dressings or none on the healing of foot ulcers in people with diabetes.

SEARCH STRATEGY:
We searched the Cochrane Wounds Group Specialised Register (searched 10 June 2011); the Cochrane Central Register of Controlled Trials (CENTRAL) (The Cochrane Library 2011, Issue 2); Ovid MEDLINE (1950 to June Week 1 2011); Ovid MEDLINE (In-Process & Other Non-Indexed Citations, June 8, 2011); Ovid EMBASE (1980 to 2011 Week 22) and EBSCO CINAHL (1982 to 3 June 2011). There were no restrictions based on language or date of publication.

SELECTION CRITERIA:
Published or unpublished randomised controlled trials (RCTs) that have compared the effects on ulcer healing of hydrogel with alternative wound dressings or no dressing in the treatment of foot ulcers in people with diabetes.

DATA COLLECTION AND ANALYSIS:
Two review authors independently performed study selection, risk of bias assessment and data extraction.

MAIN RESULTS:
We included five studies (446 participants) in this review. Meta analysis of three studies comparing hydrogel dressings with basic wound contract dressings found significantly greater healing with hydrogel: risk ratio (RR) 1.80, 95% confidence interval (CI) 1.27 to 2.56. The three pooled studies had different follow-up times (12 weeks, 16 weeks and 20 weeks) and also evaluated ulcers of different severities (grade 3 and 4; grade 2 and grade unspecified). One study compared a hydrogel dressing with larval therapy and found no statistically significant difference in the number of ulcers healed and another found no statistically significant difference in healing between hydrogel and platelet-derived growth factor. There was also no statistically significant difference in number of healed ulcers between two different brands of hydrogel dressing. All included studies were small and at unclear risk of bias and there was some clinical heterogeneity with studies including different ulcer grades. No included studies compared hydrogel with other advanced wound dressings.

AUTHORS' CONCLUSIONS:
There is some evidence to suggest that hydrogel dressings are more effective in healing (lower grade) diabetic foot ulcers than basic wound contact dressings however this finding is uncertain due to risk of bias in the original studies. There is currently no research evidence to suggest that hydrogel is more effective than larval therapy or platelet-derived growth factors in healing diabetic foot ulcers, nor that one brand of hydrogel is more effective than another in ulcer healing. No RCTs comparing hydrogel dressings with other advanced dressing types were found.
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Foam dressings for healing diabetic foot ulcers.
Dumville JC, Deshpande S, O'Meara S, Speak K.
Cochrane Database Syst Rev. 2011 Sep 7;9:CD009111.

BACKGROUND:
Foot ulcers in people with diabetes are a prevalent and serious global health issue. Dressings form a key part of ulcer treatment, with clinicians and patients having many different types to choose from. A clear and current overview of current evidence is required to facilitate decision-making regarding dressing use.

OBJECTIVES:
The review aimed to evaluate the effects of foam wound dressings on the healing of foot ulcers in people with diabetes.

SEARCH STRATEGY:
We searched the Cochrane Wounds Group Specialised Register (searched 10 June 2011); The Cochrane Central Register of Controlled Trials (CENTRAL) (The Cochrane Library 2011, Issue 2); Ovid MEDLINE (1950 to June Week 1 2011); Ovid MEDLINE (In-Process & Other Non-Indexed Citations, 8 June, 2011); Ovid EMBASE (1980 to 2011 Week 22); EBSCO CINAHL (1982 to 3 June 2011). There were no restrictions based on language or date of publication.

SELECTION CRITERIA:
Published or unpublished randomised controlled trials (RCTs) that evaluated the effects on ulcer healing of one or more foam wound dressings in the treatment of foot ulcers in people with diabetes.

DATA COLLECTION AND ANALYSIS:
Two review authors independently performed study selection, risk of bias assessment and data extraction.

MAIN RESULTS:
We included six studies (157 participants) in this review. Meta analysis of two studies indicated that foam dressings do not promote the healing of diabetic foot ulcers compared with basic wound contact dressings (RR 2.03, 95%CI 0.91 to 4.55). Pooled data from two studies comparing foam and alginate dressing found no statistically significant difference in ulcer healing (RR 1.50, 95% CI 0.92 to 2.44). There was no statistically significant difference in the number of diabetic foot ulcers healed when foam dressings were compared with hydrocolloid (matrix) dressings. All included studies were small and/or had limited follow-up times.

AUTHORS' CONCLUSIONS:
Currently there is no research evidence to suggest that foam wound dressings are more effective in healing foot ulcers in people with diabetes than other types of dressing however all trials in this field are very small. Decision makers may wish to consider aspects such as dressing cost and the wound management properties offered by each dressing type e.g. exudate management.
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NewsBot · Jul 18, 2013

Hydrogel dressings for healing diabetic foot ulcers.
Dumville JC, O'Meara S, Deshpande S, Speak K.
Cochrane Database Syst Rev. 2013 Jul 12;7:CD009101.

BACKGROUND:
Foot ulcers in people with diabetes are a prevalent and serious global health issue. Dressings form a key part of ulcer treatment, with clinicians and patients having many different types to choose from including hydrogel dressings. A clear and current overview of current evidence is required to facilitate decision-making regarding dressing use.

OBJECTIVES:
To assess the effects of hydrogel wound dressings compared with alternative dressings or none on the healing of foot ulcers in people with diabetes.

SEARCH METHODS:
For this first update, in April 2013, we searched the following databases the Cochrane Wounds Group Specialised Register; The Cochrane Central Register of Controlled Trials (CENTRAL) (The Cochrane Library); Ovid MEDLINE; Ovid MEDLINE (In-Process & Other Non-Indexed Citations); Ovid EMBASE; and EBSCO CINAHL. There were no restrictions based on language or date of publication.

SELECTION CRITERIA:
Published or unpublished randomised controlled trials (RCTs) that have compared the effects on ulcer healing of hydrogel with alternative wound dressings or no dressing in the treatment of foot ulcers in people with diabetes.

DATA COLLECTION AND ANALYSIS:
Two review authors independently performed study selection, risk of bias assessment and data extraction.

MAIN RESULTS:
We included five studies (446 participants) in this review. Meta analysis of three studies comparing hydrogel dressings with basic wound contract dressings found significantly greater healing with hydrogel: risk ratio (RR) 1.80, 95% confidence interval (CI) 1.27 to 2.56. The three pooled studies had different follow-up times (12 weeks, 16 weeks and 20 weeks) and also evaluated ulcers of different severities (grade 3 and 4; grade 2 and grade unspecified). One study compared a hydrogel dressing with larval therapy and found no statistically significant difference in the number of ulcers healed and another found no statistically significant difference in healing between hydrogel and platelet-derived growth factor. There was also no statistically significant difference in number of healed ulcers between two different brands of hydrogel dressing. All included studies were small and at unclear risk of bias and there was some clinical heterogeneity with studies including different ulcer grades. No included studies compared hydrogel with other advanced wound dressings.

AUTHORS' CONCLUSIONS:
There is some evidence to suggest that hydrogel dressings are more effective in healing (lower grade) diabetic foot ulcers than basic wound contact dressings however this finding is uncertain due to risk of bias in the original studies. There is currently no research evidence to suggest that hydrogel is more effective than larval therapy or platelet-derived growth factors in healing diabetic foot ulcers, nor that one brand of hydrogel is more effective than another in ulcer healing. No RCTs comparing hydrogel dressings with other advanced dressing types were found.
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NewsBot · Jan 16, 2014

Treatment of infected diabetic foot ulcers clinical effectiveness of a dressing of alginate and hydrocolloid, with silver fiber. Analysis of results of a series of cases.
Lázaro-Martínez JL, Cecilia-Matilla A, Aragón-Sánchez J, García-Morales E, Garcia-Alvarez Y, Alvaro-Afonso F.
Rev Enferm. 2013 Nov;36(11):29-34.

INTRODUCTION:
High levels of bacterial load have shown a deleterious influence on wound healing. Using antimicrobial dressings can control ulcers' bioburden. The aim of our study was to evaluate the improving of infected diabetic foot ulcers due an alginate's fiber and hydrocolloid silver dressing.
MATERIAL AND METHODS:
We analysed a case series of 6 patients with diabetic foot ulcers without peripheral vascular disease and diagnosed from critical colonization and/or local infection according the presence of inflammation clinical signs. Patients were treated for a minimum period of two weeks. We analysed the percentage reduction in ulcer area from the day of enrolment to antimicrobial dressing removal.
RESULTS:
The duration of treatment had a median of 5 weeks with a minimum of 2 weeks and up to 6. The median percentage of area reduction of the wounds was 47.7% (range: 0.5%-90%). The mean percentage reduction on the lesion was 58% from 2 weeks and 67.14% at 3 weeks. All patients had reduced significantly their size at 3 weeks from beginning of treatment (p < 0.05).
CONCLUSION:
The use of an alginate's fiber and hydrocolloid silver dressing promotes healing on diabetic foot ulcers with local infection, reducing the inflammatory clinical signs significantly over a period of three weeks.
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NewsBot · May 12, 2017

Hydrogel: An Overused Wound Care Modality?

NewsBot · Mar 21, 2018

PUBLIC RELEASE: 20-MAR-2018
Hydrogel may help heal diabetic ulcers
Tests show Rice University invention could accelerate tissue growth compared with current treatment
HOUSTON - (March 20, 2018) - A hydrogel invented at Rice University that is adept at helping the body heal may also be particularly good at treating wounds related to diabetes.

The Rice lab of chemist and bioengineer Jeffrey Hartgerink reported this week that tests on diabetic animal models showed the injectable hydrogel significantly accelerated wound healing compared with another hydrogel often used in clinics.
The study appears this week in the American Chemical Society journal ACS Biomaterials Science and Engineering.
The multidomain peptide (MDP) hydrogel known by its amino acid sequence - K2(SL)6K2 - has in a recent study proven useful for the timed release of immunotherapy drugs. It has also been shown to encourage healing all by itself.
That quality may be useful for people with diabetes mellitus who often develop chronic wounds in their lower extremities that take longer to heal than normal wounds.

"This is particularly exciting because the study shows our material has an effect that's positive and better than things that are already out there," Hartgerink said. "This has been a long time coming."

He said the typical treatment for a diabetic foot ulcer has not changed much over the last century.

"The current gold standard of treatment is to debride the wound, which means to remove necrotic tissue. The wound is washed, bandaged and patients are told to keep pressure off the foot," said Nicole Carrejo, a Rice graduate student and the paper's lead author. "Various treatments and materials may be tried, but oftentimes, everything fails, which can lead to amputation."

The researchers reported that Rice's MDP hydrogel significantly accelerated the healing of wounds in genetically diabetic rodents. Treatment led to wound closure in 14 days, the formation of thick granulation tissue, including dense growth of blood vessels and nerve cells, and the regeneration of hair follicles.

They compared their results with a control group treated with a commercial hydrogel that required twice as long to reach the same degree of wound closure. "Unlike our MDP hydrogel, the control hydrogel does not get infiltrated by cells," Carrejo said. "Although the control results in the healing of wounds, we believe cellular infiltration of our MDP helps lead to the acceleration of wound healing."

Hartgerink hopes to move the hydrogel toward clinical trials as a material rather than a drug to ease the federal approval process. "That would make it much more practical to do a clinical trial," he said. "These preclinical experiments have been exciting enough to warrant that thought process."

NewsBot · Aug 31, 2018

Effects of Hydrogel With Enriched Sodium Alginate in Wounds of Diabetic Patients.
Gustinelli Barbosa MA et al
Plast Surg Nurs. 2018 Jul/Sep;38(3):133-138. doi: 10.1097/PSN.0000000000000228.

Objective of this study was to evaluate the efficacy of the autolytic debridement promoted by hydrogel with sodium alginate enriched with fatty acids and vitamins A and E in the healing of foot wounds in diabetic patients. A clinical study was conducted at an outpatient clinic of medical specialties. The sample comprised 8 patients supervised for a 3-month period, from April to July 2017, by means of a clinical history, photographic record, planimetry, and classification of the wound severity by the Pressure Ulcer Scale for Healing (PUSH) system. Of the 8 patients supervised, 1 dropped out and 7 were followed up for 12 weeks. Only 2 had complete wound healing, but all presented a reduction of the lesion area of approximately 22.2% and PUSH score of 9.8 to 6.6. This study found that hydrogel showed good results for the treatment of diabetic feet, reducing the area and overall PUSH score of the wounds.
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NewsBot · Dec 12, 2019

A Systematic Review and Meta-Analysis of Clinical Effectiveness and Safety of Hydrogel Dressings in the Management of Skin Wounds.
Zhang L et al
Front Bioeng Biotechnol. 2019 Nov 21;7:342

The purpose of this systematic review and meta-analysis is to assess the clinical effectiveness and safety of the medical hydrogel dressings used in skin wounds and therefore to weight the evidence for their clinical application. PubMed/Medline (1980-2019), Cochrane Library (1980-2019), ClinicalTrials.gov, Cochrane CENTRAL, Chinese Journal Full-text Database (CNKI, 1994-2019), and China Biomedy Medicine disc (CBM, 1978-2019), Chinese Scientific Journal Database (VIP, 1989-2019), and Wanfang Database (WFDATA, 1980-2019) were searched to identify relevant clinical trials and studies. Forty-three studies that assessed hydrogel vs. non-hydrogel dressings were identified. Compared to the latter, hydrogel dressings associated with a significantly shortened healing time of degree II burn (superficial and deep) wounds, diabetic foot ulcers, traumatic skin injuries, radioactive skin injuries, dog bites, and body surface ulcers. In addition, hydrogel dressing obviously increased the cure rate of diabetic foot ulcers, surgical wounds, dog bites, and body surface ulcers. Moreover, hydrogel dressing significantly relieved pain in degree II burn (superficial and deep) wounds, traumatic skin injuries, and laser treatment-induced wounds. However, no significant differences obtained between hydrogel and non-hydrogel dressings in the healing time of surgical wounds, the cure rate of inpatients' pressure ulcers, and phlebitis ulcers. This comprehensive systematic review and meta-analysis of the available evidence reveals that the application of hydrogel dressings advances the healing of various wound types and effectively alleviates the pain with no severe adverse reactions. These results strongly indicate that hydrogel products are effective and safe in wound management.
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NewsBot · May 30, 2020

Effects of Hydrogel With Enriched Sodium Alginate in Wounds of Diabetic Patients
Murilo Antonio Gustinelli Barbosa, André Oliveira Paggiaro, Viviane Fernandes de Carvalho, César Isaac, Rolf Gemperli
Plast Surg Nurs. Apr/Jun 2020;40(2):110-115

Objective of this study was to evaluate the efficacy of the autolytic debridement promoted by hydrogel with sodium alginate enriched with fatty acids and vitamins A and E in the healing of foot wounds in diabetic patients. A clinical study was conducted at an outpatient clinic of medical specialties. The sample comprised 8 patients supervised for a 3-month period, from April to July 2017, by means of a clinical history, photographic record, planimetry, and classification of the wound severity by the Pressure Ulcer Scale for Healing (PUSH) system. Of the 8 patients supervised, 1 dropped out and 7 were followed up for 12 weeks. Only 2 had complete wound healing, but all presented a reduction of the lesion area of approximately 22.2% and PUSH score of 9.8 to 6.6. This study found that hydrogel showed good results for the treatment of diabetic feet, reducing the area and overall PUSH score of the wounds.
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NewsBot · Mar 7, 2022

The Promising Hydrogel Candidates for Preclinically Treating Diabetic Foot Ulcer: A Systematic Review and Meta-analysis
Haijian Wu et al
Adv Wound Care (New Rochelle). 2022 Mar 1

Significance: Diabetic foot ulcer (DFU) causes high amputation rates owing to its aberrant wound healing. Traditional dressings cannot effectively contribute to DFU healing. Functional hydrogels have been proposed as a promising novel dressing to treat DFU in future, but the evidence for various hydrogels to heal DFU is still ambiguous. Recent Advances: In accord with PRISMA and CONSORT guidelines, a meta-analysis was performed to evaluate the efficacy of functional hydrogels. Four electronic databases and one website were used for data searching. Twenty-four in animal studies and six clinical trials met the inclusion criteria with a total of 399 diabetic murine models and 278 patients with DFU.

Critical issues: Functional hydrogels accelerated the healing progress for DFU disease and relieved symptoms in patients. According to their characteristics, the functional hydrogels were divided into antioxidant hydrogel (AOH), antibacterial hydrogel (ABH), multifunctional hydrogel (MFH), proangiogenic hydrogel (PAH), and hydrogel promoting proliferation (PPH). By network meta-analysis, AOH and MFH were considered the premium options for treating wounds of diabetic patients at whole stage. Future Direction: Functional hydrogels effectively accelerate healing rates in wounds of diabetic animals. Hydrogels of AOH and MFH might become the ideal candidates for clinical trials on DFU treatment, based on the Meta-analyses from the reported work. Early treatment with AOH followed a week later with ABH might become an advanced strategy for DFU disease in future. This information is very important for researchers or/and physicians in taking consideration for alternate application of hydrogel dressings
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NewsBot · Jun 7, 2022

A review on wound dressings: Antimicrobial agents, biomaterials, fabrication techniques, and stimuli-responsive drug release
EmadNaseri & AliAhmadia
European Polymer Journal; Volume 173, 15 June 2022, 111293

Skin, the largest organ of the body, protects the inner organs against the ambient environment, and it is prone to internal and external injuries in the form of wounds. The wound healing process of the body can be hindered by a compromised immune system or severity of the wound, making wound care critical under these circumstances. Infection is the most prevalent complication that arises in wounds, and wound dressings are widely used to assist the self-healing process of the body for complete skin recovery. In this review, the recently developed wound dressings are reviewed, focusing on reviewing various antimicrobial agents, biomaterials, and fabrication techniques. In moving toward green chemistry, the importance of using non-toxic solvents for fabricating wound dressing is emphasized. Finally, the importance of using stimuli-responsive wound dressings as a recent trend in wound dressing is highlighted. The outcome of this review will lead to novel research in the field of wound dressing and drug-eluting constructs.
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NewsBot · Jan 30, 2023

Hydrogel-based Treatment Strategies to Accelerate Diabetic Foot Ulcer Healing
Sadgi et al
Curr Diabetes Rev. 2023 Jan 27

A diabetic foot ulcer is a chronic clinical manifestation of diabetes that exacerbates the condition of a patient and has a considerable socioeconomic impact. A diabetic foot ulcer (DFU) impacts around 25% of patients with diabetes mellitus at a certain point in their lives, and the underlying cause of the condition appears to be linked to neuropathic, ischaemic, and/or neuro-ischaemic pathologies [1]. For the effective treatment of DFU, a variety of conventional treatments are used. However, in recent years, a range of innovative materials have been studied to bolster standard treatment tactics and promote the desired biological response by transcending the impediments of current wound healing approaches. Inorganic/organic hydrogel hybrids for tissue regeneration are among the most promising materials. This review article outlines the current treatment options for DFU, applications of hydrogel with an emphasis on wound healing, polymeric materials used to fabricate hydrogel, and the role of emerging technologies.
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NewsBot · Jun 6, 2023

Scoping Review of Hydrogel Therapies in the Treatment of Diabetic Chronic Wounds
Ayushi D. Sharma et al
Plast Reconstr Surg Glob Open. 2023 May; 11(5): e4984.

Background:
Chronic diabetic wounds are a significant issue that can be treated with topical hydrogel therapies. The aim of this study was to review the different compositions of hydrogel that have been developed and analyze their clinical relevance in the treatment of chronic diabetic wounds.

Methods:
We conducted a scoping review in which twelve articles were selected for review after applying relevant inclusion and exclusion criteria using a two-reviewer strategy. Data extracted from these studies was used to answer the following research question: What is the composition of hydrogels used to treat chronic diabetic wounds and how effective are they?

Results:
We analyzed five randomized controlled trials, two retrospective studies, three reviews, and two case reports. Hydrogel compositions discussed included mesenchymal stem cell sheets, carbomer, collagen, and alginate hydrogels, as well as hydrogels embedded with platelet-derived growth factor. Synthetic hydrogels, largely composed of carbomers, were found to have high levels of evidence supporting their wound healing properties, though few articles described their routine use in a clinical setting. Collagen hydrogels dominate the present-day hydrogel market in the clinical treatment of chronic diabetic wounds. The augmentation of hydrogels with therapeutic biomaterials is a new field of hydrogel research, with studies demonstrating promising early in vitro and in vivo animal studies demonstrating promising early results for in vitro and in vivo animal investigations.

Conclusions:
Current research supports hydrogels as a promising topical therapy in the treatment of chronic diabetic wounds. Augmenting Food & Drug Administration-approved hydrogels with therapeutic substances remains an interesting early area of investigation.
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NewsBot · Jan 11, 2024

Smart Nanofibrous Hydrogel Wound Dressings for Dynamic Infection Diagnosis and Control: Soft but Functionally Rigid
Raj Kumar Sen et al
ACS Appl Bio Mater. 2024 Jan 10

Chronic wounds, such as burns and diabetic foot ulcers, pose significant challenges to global healthcare systems due to prolonged hospitalization and increased costs attributed to susceptibility to bacterial infections. The conventional use of antibiotic-loaded and metal-impregnated dressings exacerbates concerns related to multidrug resistance and skin argyrosis. In response to these challenges, our research introduces a unique approach utilizing antibiotic-free smart hydrogel wound dressings with integrated infection eradication and diagnostic capabilities. Electrospinning stands out as a method capable of producing hydrogel nanofibrous materials possessing favorable characteristics for treating wounds and detecting infections under conditions utilizing sustainable materials. In this study, innovative dressings are fabricated through electrospinning polycaprolactone (PCL)/gelatin (GEL) hybrid hydrogel nanofibers, incorporating pDA as a cross-linker, εPL as a broad-spectrum antimicrobial agent, and anthocyanin as a pH-responsive probe. The developed dressings demonstrate exceptional antioxidant (>90% radical scavenging) and antimicrobial properties (95-100% killing). The inclusion of polyphenols/flavonoids and εPL leads to absolute bacterial eradication, and in vitro assessments using HaCaT cells indicate increased cell proliferation, decreased reactive oxygen species (ROS) production, and enhanced cell viability (100% Cell viability). The dressings display notable alterations in color that correspond to different wound conditions. Specifically, they exhibit a red/violet hue under healthy wound conditions (pH 4-6.5) and a green/blue color under unhealthy wound conditions (pH > 6.5). These distinctive color changes provide valuable insights into the versatile applications of the dressings in the care and management of wounds. Our findings suggest that these antibiotic-free smart hydrogel wound dressings hold promise as an effective and sustainable solution for chronic wounds, providing simultaneous infection control and diagnostic monitoring. This research contributes to advancing the field of wound care, offering a potential paradigm shift in the development of next-generation wound dressings.
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NewsBot · Apr 17, 2024

Evaluating a promising methylcellulose hydrogel for enhanced diabetic foot ulcer therapy through comprehensive preclinical studies
Priya Patel et al
J Biomater Sci Polym Ed. 2024 Mar 27:1-18

The present research focuses on formulating and evaluating hydrogels modified with crosslinking agents using methylcellulose to treat diabetic foot ulcers (DFU). Methylcellulose hydrogels are prepared and characterized for their crosslinking capacity through FTIR and degradation studies. The optimized hydrogel is further assessed for viscosity, gel strength, contact angle, in-vitro biodegradation, water-vapor transmission rate, anti-bacterial activity, and in-vivo efficacy. The results demonstrate that the developed hydrogel exhibits promising properties for DFU treatment, including increased wound healing percentage, improved ulcer morphology, reduced levels of proinflammatory cytokines, and enhanced tissue characteristics. These findings suggest that the novel hydrogel composition could serve as a viable alternative to existing dressings for DFU management.
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