“Diabetic Foot Ulcer” is described as a specific type of ulcer that develops as a result of the underlying pathologies associated with diabetes. When a person is suffering from diabetes mellitus they undergo a phenomenon known as diabetic neuropathy (Anandhanarayanan et al., 2022). Anaesthesia or hypoaesthesia is seen in the regions of the skin where the cutaneous nerves are affected by this neuropathy. Especially, when this loss of sensation is present in the foot region. The patient is unable to sense repeated trauma during daily activities such as walking. As a result of this, they are at risk of developing an ulcer in these regions of repeated trauma (Urso et al., 2021). Diabetic patients are also subject to macro and microvascular changes in the body (Oliver & Mutluoglu, 2022). As a result of these changes, the blood supply to organs and limbs is compromised and this compromise is seen most prominently in distal extremities such as hands and feet (Burgess et al., 2021). This results in a reduced supply of oxygen and nutrients to these regions making any ulcers present very difficult to heal. Poor glycemic control also increases the incidence of this ulcer becoming infected, which further delays healing (Burgess et al., 2021).
There are several evidence-based interventions available for the management of this condition that have been studied and evaluated in various systematic reviews (Andrew et al., 2022). This essay will evaluate and analyse the quality of evidence available in support of a few of these interventions. Further, based on research that qualifies as high-quality, the usefulness of these interventions will be evaluated based on the rapidity, cost-effectiveness and patient acceptability while healing these ulcers. The improvements or deterioration in the general quality of life in persons receiving these interventions will be analysed as the basis of recommendations developed. With all these considerations, an evidence-based management plan for diabetic foot ulcers will be developed that provides the best possible likelihood of good healing of the ulcer while also providing the best possible quality of life for the patients undergoing intervention.
Diabetic foot ulcer not only causes a decrease in quality of life due to the ulcer itself but also due to its complications which are very severe and not limited to osteomyelitis, amputation or even septicemia and death (Edmonds et al., 2021). This condition affects the patient not only physically but also psychologically. Increased levels of depression and anxiety are observed among these patients (Polikandrioti et al., 2020). However, the standards of living for people living with diabetic foot ulcers can be drastically improved by providing patients with early detection and appropriate management of this condition (Jayalakshmi et al., 2020).
The clinical expertise of healthcare professionals, patient preference and evidence-based practice are three components that are essential to the development and implementation of interventions (Tringale et al., 2022; Connor et al., 2023). Healthcare professionals must use their clinical expertise to read and evaluate the literature available regarding the available treatment methodologies for a condition. Following this, an evidence-based management plan should be developed which has high acceptability for the patient. The factors that determine patient acceptability would include expense, effectiveness and comfort of complying with the treatment (Batbaatar et al., 2016). This method can be used to develop the best possible intervention strategies to meet the needs of a population.
The International Working Group on Diabetic Foot (IWGDF), develops guidelines for treating diabetic foot ulcers that use evidence-based medicine for almost two decades (Rayman et al., 2019). According to the 2019 updated policies, the recommendations are as follows Debridement, use of placenta-derived products, comfortable and cheap dressing primarily with the intention of exudation control, antimicrobials not to be included unless the wound is infected, and use of dressing impregnated with sucrose octa sulphate. They also recommend avoiding the use of topical oxygen therapy but the use of systemic hyperbaric oxygen therapy is recommended as also the use of autologous fibrin, platelets or leukocytes. The IWGDF however, recommends against the use of negative pressure wound therapy in diabetic foot wounds that are not a result of surgery. The review will discuss various pieces of literature that evaluate the effectiveness of the recommended management modalities for foot ulcers.
Table of Studies Evaluated
Author |
Year |
Study Design |
Methodology |
Population |
Interventions |
Comparator intervention |
Outcome |
|
1 |
Liu et al. |
2017 |
Systematic Review of RCTs |
Meta-Analysis |
Diabetics with foot ulcers |
Negative Pressure Wound Therapy |
Standard dressing |
Effective, safe and economical |
2 |
Game et al. |
2018 |
RCT |
Multi-centre and observer-blinded. |
Diabetic patients suffering from ulcer foot. |
LeucoPatch |
Standard dressing |
Improved Healing |
3 |
Frykberg et al. |
2019 |
RCT |
Multi-centre, Double-Blinded, |
People with Diabetes mellitus with foot ulcer |
Topical wound oxygen therapy |
Placebo |
No significant difference |
4 |
Zhang et al. |
2022 |
Systematic Review of RCTs |
Meta-Analysis |
Diabetic foot ulcer patients |
Hyperbaric Oxygen Therapy |
Standard care for patients with ulcer foot in diabetes |
Improved healing and reduced amputations |
5 |
Tettelbach et al. |
2019 |
RCT |
Prospective multi-centre study. Not blinded. |
People with foot ulcers on underlying diabetes mellitus |
Dehydrated Human Umbilical Cord Allograft |
Standard care for diabetic foot ulcer |
Safe and Effective |
The effectiveness of various treatment modalities that are used for patients developing a foot ulcer over an underlying pathology of diabetes mellitus has been examined in several research papers. Negative-pressure wound therapy outperformed traditional dressings concerning wound healing rate and the duration it takes for a full recovery. According to a systematic review and meta-analysis by Liu et al. (2017), The incidence of unfavourable occurrences between the two therapies did not significantly differ. Game et al., (2018) The LeucoPatch method employs a patch containing the patient's leukocytes and serves as a remedy. For its efficiency in managing hard-to-heal diabetic foot ulcers; the study found that the intervention group had 34% more ulcers that completely healed compared to the control group. According to the study, 34% more ulcers in the intervention group than in the control group were healed. The treatment's viability is called into doubt by the high cost of the visits that the patient needs to make every week for venesection, The preparation as well as the application of the patch are also specialised skills that reduce the accessibility of this treatment. Frykberg et al. (2019) a randomised, double-blinded, placebo-controlled experiment observed no statistically significant difference between the group that received topical wound oxygen therapy. The group did not include the percentage of patients who obtained complete wound closure. Zhang et al. (2022) provide a comparison to normal care or sham therapy, hyperbaric oxygen therapy was reported to be related to a considerably better rate of full wound healing. Tettelbach et al. (2019) study reports that a multicenter, prospective, randomised controlled comparative on EpiCord allograft (dehydrated human umbilical cord) is a secure and reliable choice for treating diabetic foot ulcers. Overall, these studies offer important knowledge on the efficacy of various therapies for diabetic foot ulcers and point to the need for additional studies to confirm the most effective procedures.
Based on the above studies the following recommendations can be made. Negative-pressure wound therapy is an effective treatment option that provides faster wound healing and reduced hospitalisation duration hence should be used routinely in care.
LeucoPatch system and cyclical topical wound oxygen therapy have shown mixed results in treating diabetic foot ulcers cannot be advised until more studies have been done because there is not enough proof of their effectiveness at this time. They need further evaluation before they can be added to recommendations for standard care. Hyperbaric oxygen therapy has shown promising results in healing diabetic foot ulcers such that it can be recommended in cases where the therapy is easily accessible and there is a delay in healing of the ulcer with other treatments. However, due to the limited availability of hyperbaric oxygen chambers, this treatment option can be limited to cases of delayed healing wounds.
The use of Dehydrated human umbilical cord allograft has shown to be a safe and successful therapeutic option, with a higher percentage of patients obtaining that were able to progress to complete healing of that previously poorly healing wounds. However, considerations of the cost-effectiveness of the treatment prevent its recommendation as standard practice.
In conclusion, the treatment that is recommended to patients suffering from diabetic foot should be individualized and may involve a combination of different treatment options. Depending on the severity and characteristics of the ulcer; it is essential to regularly monitor and manage blood glucose levels, as well as provide appropriate foot care and education to prevent future ulcerations. The standards of living for these people are highly limited due to the physical and emotional effects of the disease and the treatment plan used should be effective, and provide quicker healing. So, that the patient can be discharged earlier, reduce the incidence of complications such as amputation as well as be cost-effective manner. As patients are already faced with the high economic burden of the primary illness -diabetes. Among these studies, Negative-pressure wound therapy is an effective treatment option but LeucoPatch, cyclical topical wound oxygen therapy, hyperbaric oxygen therapy and umbilical cord allograft-based management need further studies to establish their benefits and cost-effectiveness. So, the following are the recommendation that needs to include as part of standard care although they can be useful in limited circumstances.
Anandhanarayanan, A., Teh, K., Goonoo, M., et al. (2022). Diabetic Neuropathies. In Feingold, K. R., Anawalt, B., Blackman, M. R., et al. (Eds.), Endotext. MDText.com, Inc. Retrieved from https://www.ncbi.nlm.nih.gov/books/NBK279175/
Batbaatar E, Dorjdagva J, Luvsannyam A, Savino MM, Amenta P. (2017). Determinants of patient satisfaction: a systematic review. Perspectives in Public Health, 137(2), 89-101. https://doi.org/10.1177/1757913916634136
Burgess, J. L., Wyant, W. A., Abdo Abujamra, B., Kirsner, R. S., & Jozic, I. (2021). Diabetic Wound-Healing Science. Medicina, 57(10), 1072. https://doi.org/10.3390/medicina57101072
Connor L, Dean J, McNett M, Tydings DM, Shrout A, Gorsuch PF, Hole A, Moore L, Brown R, Melnyk BM, Gallagher-Ford L. (2023). Evidence-based practice improves patient outcomes and healthcare system return on investment: Findings from a scoping review. Worldviews on Evidence-Based Nursing, 20(1), 6-15. https://doi.org/10.1111/wvn.12621
Edmonds M, Manu C, Vas P. (2021). The current burden of diabetic foot disease. Journal of Clinical Orthopaedics and Trauma, 17, 88-93. https://doi.org/10.1016/j.jcot.2021.01.017
Frykberg, R. G., Franks, P. J., Edmonds, M., Brantley, J. N., Téot, L., Wild, T., Garoufalis, M. G., Lee, A. M., Thompson, J. A., Reach, G., Dove, C. R., Lachgar, K., Grotemeyer, D., & Renton, S. C.; TWO2 Study Group. (2020). A multinational, multicenter, randomized, double-blinded, placebo-controlled trial to evaluate the efficacy of cyclical topical wound oxygen (TWO2) therapy in the treatment of chronic diabetic foot ulcers: The TWO2 Study. Diabetes Care, 43(3), 616-624. https://doi.org/10.2337/dc19-0476
Game, F., Jeffcoate, W., Tarnow, L., Jacobsen, J. L., Whitham, D. J., Harrison, E. F., Ellender, S. J., Fitzsimmons, D., & Löndahl, M.; LeucoPatch II trial team. (2018). LeucoPatch system for the management of hard-to-heal diabetic foot ulcers in the UK, Denmark, and Sweden: An observer-masked, randomised controlled trial. Lancet Diabetes & Endocrinology, 6(11), 870-878. https://doi.org/10.1016/S2213-8587(18)30240-7
Jayalakshmi, M. S., Thenmozhi, P., & Vijayaragavan, R. (2020). Impact of the chronic wound on quality of life among diabetic foot ulcer patients in a selected hospital of Guwahati, Assam, India. Ayu, 41(1), 19-23. https://doi.org/10.4103/ayu.AYU_33_20
Liu S, He CZ, Cai YT, Xing QP, Guo YZ, Chen ZL, Su JL, Yang LP. (2017). Evaluation of negative-pressure wound therapy for patients with diabetic foot ulcers: systematic review and meta-analysis. Therapeutics and Clinical Risk Management, 13, 533-544. https://doi.org/10.2147/tcrm.s131193
Oliver, T. I., & Mutluoglu, M. (2023). Diabetic Foot Ulcer. In StatPearls. StatPearls Publishing. PMID: 30726013.
Polikandrioti M, Vasilopoulos G, Koutelekos I, Panoutsopoulos G, Gerogianni G, Babatsikou F, Zartaloudi A, Toulia G. (2020). Quality of life in diabetic foot ulcer: associated factors and the impact of anxiety/depression and adherence to self-care. International Journal of Low Extremity Wounds, 19(2), 165-179. https://doi.org/10.1177/1534734619900415
Rayman G, Vas P, Dhatariya K, Driver V, Hartemann A, Londahl M, Piaggesi A, Apelqvist J, Attinger C, Game F; International Working Group on the Diabetic Foot (IWGDF). (2020). Guidelines on use of interventions to enhance healing of chronic foot ulcers in diabetes (IWGDF 2019 update). Diabetes & Metabolism, 46(4), 253-269. https://doi.org/10.1016/j.diabet.2020.03.004
Tettelbach, W., Cazzell, S., Sigal, F., Caporusso, J. M., Agnew, P. S., Hanft, J., & Dove, C. (2019). A multicentre prospective randomised controlled comparative parallel study of dehydrated human umbilical cord (EpiCord) allograft for the treatment of diabetic foot ulcers. International Wound Journal, 16(1), 122-130. https://doi.org/10.1111/iwj.13001
Tringale M, Stephen G, Boylan AM, Heneghan C. (2022). Integrating patient values and preferences in healthcare: a systematic review of qualitative evidence. BMJ Open, 12(11), e067268. https://doi.org/10.1136/bmjopen-2022-067268
Urso, B., Ghias, M., John, A., & Khachemoune, A. (2021). Neuropathic ulcers: a focused review. International Journal of Dermatology, 60(10), e383-e389. https://doi.org/10.1111/ijd.15362
Zhang, Z., Zhang, W., Xu, Y., & Liu, D. (2022). Efficacy of hyperbaric oxygen therapy for diabetic foot ulcers: An updated systematic review and meta-analysis. Asian Journal of Surgery, 45(1), 68-78. https://doi.org/10.1016/j.asjsur.2021.07.047
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