ENERGI-F703 gel, as a new topical treatment for diabetic foot and leg ulcers: A multicenter, randomized, double-blind, phase II trial

Yang, Jui-Yung; Chen, Cha-Chun; Chang, Stephen S.; Yeh, Jiun‐Ting; Huang, Hui-Fu; Lin, Hwang-Chi; Lin, Shang-Hsi; Lin, Yu-Hsien; Wei, Lin-Gwei; Liu, Tom J.; Hung, Shih-Yuan; Yang, Hsiao Bai; Chang, Hui-hsiu; Wang, Chih-Hsin; Tzeng, Yuan‐Sheng; Huang, Chieh-Huei; Chou, Chang-Yi; Lin, Yu Ting; Yang, Shih-Yi; Chen, Han-Min; Lin, Jiun‐Tsai; Cheng, Yingying; Young, Guang-Huar; Huang, Chiung-Shing; Kuo, Ya-Chun; Dai, Niann‐Tzyy

doi:10.1016/j.eclinm.2022.101497

Cited by 5 publications

(8 citation statements)

References 25 publications

(36 reference statements)

Supporting

Mentioning

Contrasting

Order By: Relevance

“…None showed a benefit in terms of our outcomes of choice in which we had no level of confidence. The interventions were: a resorbable glass microfiber matrix, 73 NorLeu3‐A (1–7) an analogue of the naturally occurring peptide, angiotensin 1–7, 74 a semi‐permeable membrane, 75 Mepilex Lite, 76 a topical EPO‐containing hydrogel formulation, 77 an Arginine ‐glycine aspartic acid peptide matrix, 78 a study of topical Chitosan and/or isosorbide dinitrate, 79 topical tretinoin 80 , topical ENERGI‐F703, 81 a soluble yeast b‐1,3/1,6‐glucan, 82 a kiwifruit extract 83 a zinc oxide tape, 84 a Venlafaxine and matrix metalloproteinase drug‐loaded cellulose nanofiber sheet, 85 an alpha connexin carboxy‐terminal, 86 topical pirfenidone 87 and a chloramine gel 88 …”

Section: Resultsmentioning

confidence: 99%

“…15 studies reported complete wound healing 73–82,86–90 . All but 3 of the studies 73,81,86 were considered at high risk of bias.…”

Section: Resultsmentioning

confidence: 99%

“…88 Outcome: Complete wound healing 15 studies reported complete wound healing. [73][74][75][76][77][78][79][80][81][82][86][87][88][89][90] All but 3 of the studies 73,81,86 were considered at high risk of bias. One 73 investigated the use of a resorbable microfibre matrix in an outcome blind study of just 40 participants.…”

Section: Other Dressingsmentioning

confidence: 99%

See 2 more Smart Citations

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

Chen,

Vilorio,

Dhatariya

et al. 2024

Diabetes Metabolism Res

View full text Add to dashboard Cite

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.

show abstract

Section: Resultsmentioning

confidence: 99%

“…15 studies reported complete wound healing 73–82,86–90 . All but 3 of the studies 73,81,86 were considered at high risk of bias.…”

Section: Resultsmentioning

confidence: 99%

See 1 more Smart Citation

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

Chen,

Vilorio,

Dhatariya

et al. 2024

Diabetes Metabolism Res

View full text Add to dashboard Cite

show abstract

“…The above-mentioned therapies have shown prominent effects in both acute and chronic conditions; however, major drawbacks such as limited cell survival, a shorter half-life, and adverse effects (oral ulcer and high cell death) constantly exert pressure on pharmaceutical companies to generate more sustainable therapies. Constant efforts are being made to develop more efficient therapies against DFU infections; these involve few readily available therapies such as Leucopatch [114] and Apligraph [115] as graft therapies against DFU infection. However, more drugs are still required to achieve commercialization.…”

Section: Bioactive Moleculesmentioning

confidence: 99%

A Review of Immunomodulatory Reprogramming by Probiotics in Combating Chronic and Acute Diabetic Foot Ulcers (DFUs)

et al. 2022

View full text Add to dashboard Cite

Diabetic foot ulcers (DFUs) are characterized by a lack of angiogenesis and distal limb diabetic neuropathy. This makes it possible for opportunistic pathogens to protect the biofilm-encased micro-communities, causing a delay in wound healing. The acute and chronic phases of DFU-associated infections are distinguished by the differential expression of innate proinflammatory cytokines and tumor necrosis factors (TNF-α and -β). Efforts are being made to reduce the microbial bioburden of wounds by using therapies such as debridement, hyperbaric oxygen therapy, shock wave therapy, and empirical antibiotic treatment. However, the constant evolution of pathogens limits the effectiveness of these therapies. In the wound-healing process, continuous homeostasis and remodeling processes by commensal microbes undoubtedly provide a protective barrier against diverse pathogens. Among commensal microbes, probiotics are beneficial microbes that should be administered orally or topically to regulate gut–skin interaction and to activate inflammation and proinflammatory cytokine production. The goal of this review is to bridge the gap between the role of probiotics in managing the innate immune response and the function of proinflammatory mediators in diabetic wound healing. We also highlight probiotic encapsulation or nanoformulations with prebiotics and extracellular vesicles (EVs) as innovative ways to tackle target DFUs.

show abstract

“…The self-repair ability of the skin tissue is limited, and the wound-healing process is slow and complex . When skin injury occurs without timely intervention, there will be a decrease in local blood flow, followed by inflammatory cell infiltration, and then induce muscle spasms, seriously affecting wound healing and even developing into a chronic injury. , In the case of diabetic foot wounds, it has been reported that nearly 2% of patients are at risk of amputation due to recurrent skin tissue ulcers each year. – How to accelerate wound healing has become a global health challenge problem, and efficient and safe products are urgently needed.…”

Section: Introductionmentioning

confidence: 99%

Egg White Peptides Accelerating the Wound Healing Process Through Modulating the PI3K-AKT Pathway: A Joint Analysis of Transcriptomic and Proteomic

Ge,

Yang,

Lyu

et al. 2024

J. Agric. Food Chem.

View full text Add to dashboard Cite

Wound healing is a multiphase process with a complex repair mechanism; trauma-repairing products with safety and high efficiency have a great market demand. Egg white peptides (EWP) have various physiological regulatory functions and have been proven efficient in ameliorating skin damage. However, their underlying regulation mechanism has not been revealed. This study further evaluated the EWP ameliorating mechanism by conducting a full-thickness skin wound model. Results demonstrated that EWP administration significantly inhibited the expression of pro-inflammatory and shortened the inflammatory phase. Besides, EWP can accelerate the secretion of growth factors (PDGF, VEGF, and TGF-β1) in skin tissue, significantly increasing the regeneration of granulation tissue and endothelium in the proliferation phase, thereby promoting wound healing. After 400 mg/kg EWP interventions for 13 days postoperation, the wound healing rate reached 90%. The combination of transcriptomic and proteomic analyses demonstrated the ameliorating efficiency effects of EWP on wound healing. EWP mainly participates in the functional network with the PI3K-AKT signaling pathway as the core to accelerate wound healing. These findings suggest a promising EWP-based strategy for accelerating wound healing.

show abstract

ENERGI-F703 gel, as a new topical treatment for diabetic foot and leg ulcers: A multicenter, randomized, double-blind, phase II trial

Cited by 5 publications

References 25 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

A Review of Immunomodulatory Reprogramming by Probiotics in Combating Chronic and Acute Diabetic Foot Ulcers (DFUs)

Egg White Peptides Accelerating the Wound Healing Process Through Modulating the PI3K-AKT Pathway: A Joint Analysis of Transcriptomic and Proteomic

Contact Info

Product

Resources

About