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Natural Medicine Journal

October 2, 2024

Low-Level Laser Therapy for Diabetic Foot Ulcers

Results from an exploratory study

Aminah Keats

ND, FABNO
This noninvasive therapy improves wound healing and quality of life for patients.

Reference

Dos Santos CM, de Souza Lima da Silveira PR, da Rocha RB, et al. Adherence to self-care and quality of life of patients with diabetic foot ulcers treated with low-level laser therapy: an exploratory study. Adv Skin Wound Care. 2024;37(8):1-10. 

Study Objective

To evaluate the quality of life (QoL) of patients with diabetic foot ulcers (DFUs) undergoing treatment with low-level laser therapy (LLLT) and its association with adherence to self-care

Key Takeaway

LLLT had a positive impact on QoL as assessed by the Short-Form 36 (SF-36) questionnaire, and investigators observed a positive association between QoL and self-care. 

Design

Randomized, exploratory study 

Participants

The study analysis included 62 participants. Patients were included in this study if they were aged 18 years or more, had type 2 diabetes mellitus, and had a diabetic foot ulcer without an infectious process. 

Exclusion criteria included the presence of an autoimmune disease, psychiatric or cognitive disorder that prevented the patient from completing questionnaires, pressure injury or venous ulcer, or contraindications to the treatment methods adopted.

There were no significant differences between the study groups in terms of age, body mass index, capillary blood glucose level, or ulcer duration. 

There were 4 groups (see below), with the LLLT group 1 and LLLT group 3 having the highest percentages of female participants (57.14% and 53.85%, respectively).

Intervention

Investigators divided the participants into the following 4 groups:

  1. Control group (CG) with LLLT placebo 
  2. LLLT group 1 (LG1) at 10 J/cm2
  3. LLLT group 2 (LG2) at 8 J/cm2
  4. LLLT group 3 (LG3) at 4 J/cm2

Investigators analyzed the following number of participants in each group: CG=18, LG1=14, LG2=17, and LG3=13. 

The participants and the outcome evaluator were blinded to the study group assignments.

Participants received LLLT (or placebo) twice a week, for a total of 20 sessions.

Participants in the treatment groups received LLLT with 904-nm wavelength using ENDOPHOTON equipment with a power of 45 mW and a dosage according to the allocation (10, 8, or 4 J/cm2). The CG received placebo application with the device turned off.

All participants received conventional treatment, which included standard cleaning and dressing. 

Study Parameters Assessed

All participants underwent 3 assessments: 1) initially at the study’s start, 2) after 10 applications of LLLT (ie, 5 weeks), and 3) after 20 applications of LLLT (ie, 10 weeks). 

Evaluation took place in the following steps:

  1. Completion of the Short-Form 36 Health Survey and the Summary of Diabetes Self-Care Activities (SDSCA) questionnaires 
  2. Vascular assessment
  3. Neurologic assessment
  4. Determination of pain level
  5. Capillary blood glucose level and DFU assessment. 

Primary Outcome

The primary outcome was patient QoL, as assessed using the SF-36 questionnaire.

Secondary outcomes were healing time (total number of visits performed until healing), percentage with complete healing (percentage of patients who achieved healing in each group), self-care, and pain levels.

Key Findings

The CG had the lowest healing rate, and LG1 achieved the highest healing rate. LG2 had the highest percentage of complete healing up to the 5th week (47.06%). LG1 had the highest percentage of healing up to the 10th week (85.71%). The CG had the lowest percentages in the 5th and 10th weeks, 16.67% and 33.33%, respectively.

LG2 participants had improvement in adherence to foot care (Z=−2.058; P=0.04), and in the CG, there was an improvement in adherence to exercise (Z=−2.047; P=0.41).

LG1 showed improvements in functional capacity after the intervention (χ22=−0.821; P=0.030) and reduction in pain levels at follow-up (χ22=−0.893; P=0.018).

Investigators observed an improvement in vitality in LG2 after the intervention

(χ22=−1.029; P=0.008) and at follow-up (χ22=−1.088; P=0.005). 

The CG showed improvements in functional capacity after the intervention (χ22=−0.972, P=0.01) and at follow-up (χ22=−0.861; P=0.029).

The CG showed a significant relationship between pain values and QoL. Higher pain levels were related to low scores on emotional aspects (ρ[16]=−0.769; P<0.001)

and the pain domain (ρ[16]=−0.541; P=0.02).

In LG1, significant relationships were observed between the physical limitation domain and blood glucose monitoring (ρ[13]=0.759; P=0.002), the pain domain and foot care (ρ[13]=0.669; P=0.009), and the general health status (GHS) domain and foot care (ρ[13]=0.542; P=0.04). 

In LG2, there were significant relationships between physical limitation and blood glucose monitoring (ρ[16]=−0.548; P=0.02), vitality and foot care (ρ[16]=0.568; P=0.01), and the GHS domain and diet (ρ[16]=−0.504; P=0.03).

Only the LG3 group showed no significant change in any QoL domains. 

Transparency

The study was funded by Fundação de Amparo à Pesquisa do Estado do Piauí (FAPEPI), which provided a public financial support grant. This institution played

no role in the design, conduct, and reporting of the study. The authors have disclosed no other financial relationships related to this article.

Practice Implications & Limitations

Diabetic foot ulcers are defined as wounds extending through the full thickness of the skin below the level of the ankle.1 Diabetic foot ulceration is a common complication of diabetes mellites (DM), and it is associated with infection, amputation, and sepsis, which can lead to death.2 It is the leading cause of nontraumatic amputation in the Western world. Approximately 1 in 4 patients with diabetes will develop a foot ulcer in his or her lifetime.3 It has been estimated that 15% to 25% of people with diabetes will be affected by foot ulcers at some time in their life.4

This condition is also associated with increased mortality risk. Patients with DFU have an increased risk of all-cause mortality, which is estimated to be more than double that of diabetic patients without this complication.5 Five-year mortality is 2.5 times higher for individuals with a DFU versus individuals with DM who do not develop an ulcer.6 The nature of these ulcers tends to be refractory, where there is a high recurrence rate after healing. Approximately 40% of DFUs recur within 1 year of healing, nearly 60% recur within 3 years, and 65% recur within 5 years. 

Approximately 1 in 4 patients with diabetes will develop a foot ulcer in his or her lifetime.

The incidence of ulceration takes an economic toll as well, which can burden healthcare systems. In the US, estimated annual spending on DFUs ranges from $9.1 billion to $13.2 billion.7 Treatment of DFUs accounts for approximately 1/3 the total cost of diabetic care, which was estimated to be US $176 billion in direct healthcare expenditures in 2012.8 Direct treatment cost includes wound dressings, antibiotics, surgery, specialist footwear, staff costs, and hospital admissions.9 This burden is heightened when DFU complication leads to the need for amputation.

The standard practices in DFU management include surgical debridement, dressings to facilitate a moist wound environment and exudate control, wound offloading, vascular assessment, and infection and glycemic control.10 Diabetic foot care typically includes a surgeon (general, vascular, orthopedic), podiatrist, diabetes specialist, physical therapist, and wound care nurse.

Low-level laser therapy is a noninvasive, safe modality that should be considered as an adjuvant treatment for patients with diabetic foot ulcers based on the results of this study and previous study findings.11 The authors of the study hypothesized that as a result of healing after LLLT treatment, patients with DFU would achieve improved quality of life.12 The study proved the hypothesis, showing that the control group had the lowest rate of healing and LG1 had the highest healing rate. In addition, achievement of healing has been associated with higher values of functional capacity compared to those who do not heal. 

Due to the severity and complications of diabetic ulcers, there is an urgent need to include additional modalities, such as LLLT, as part of a multidisciplinary approach. 

Conflict of Interest Disclosure

The author declares no conflict of interest.

Categorized Under

Aminah Keats, ND, FABNO

Aminah Keats

ND, FABNO

Aminah Keats, ND, FABNO, received her undergraduate degree in psychology from Spelman College and completed premedical coursework at Rutgers University. After completing her naturopathic medical training at the University of Bridgeport College of Naturopathic Medicine, Keats completed a 2-year, hospital-based residency in naturopathic oncology at Cancer Treatment Centers of America (CTCA). She then continued her work at CTCA as a naturopathic oncology consultant and director of naturopathic medicine. She currently practices naturopathic medicine and specializes in naturopathic oncology at Capital Integrative Health in Bethesda, Maryland. Keats also serves as a faculty member at Maryland University of Integrative Health. She is a member of the American Association of Naturopathic Physicians, the Oncology Association of Naturopathic Physicians, and member of the OncANP Board of Directors. You can find Keats on Facebook and on Instagram @draminahkeats or at her website: drkeats.com.

References

  1. Apelqvist J, Bakker K, van Houtum WH, Nabuurs-Franssen MH, Schaper NC. International consensus and practical guidelines on the management and the prevention of the diabetic foot. International Working Group on the Diabetic Foot. Diabetes Metab Res Rev. 2000;16 Suppl 1:S84-S92.
  2. Wang X, Yuan CX, Xu B, Yu Z. Diabetic foot ulcers: classification, risk factors and management. World J Diabetes. 2022;13(12):1049-1065.
  3. Armstrong DG, Boulton AJM, Bus SA. Diabetic foot ulcers and their recurrence. N Engl J Med. 2017;376(24):2367-2375.
  4. Boulton AJ, Armstrong DG, Albert SF, Frykberg RG, Hellman R, Kirkman MS. Comprehensive foot examination and risk assessment: a report of the Task Force of the Foot Care Interest Group of the American Diabetes Association, with endorsement by the American Association of Clinical Endocrinologists. Diabetes Care. 2008;31(8):1679-1685.
  5. Saluja S, Anderson SG, Hambleton I, et al. Foot ulceration and its association with mortality in diabetes mellitus: a meta-analysis. Diabet Med. 2020;37(2):211-218.
  6. Walsh JW, Hoffstad OJ, Sullivan MO, Margolis DJ. Association of diabetic foot ulcer and death in a population-based cohort from the United Kingdom. Diabet Med. 2016;33(11):1493-1498.
  7. Rice JB, Desai U, Cummings AK, Birnbaum HG, Skornicki M, Parsons NB. Burden of diabetic foot ulcers for medicare and private insurers [published correction appears in Diabetes Care. 2014;37(9):2660]. Diabetes Care. 2014;37(3):651-658.
  8. Everett E, Mathioudakis N. Update on management of diabetic foot ulcers. Ann N Y Acad Sci. 2018;1411(1):153-165.
  9. Stockl K, Vanderplas A, Tafesse E, Chang E. Costs of lower-extremity ulcers among patients with diabetes. Diabetes Care. 2004;27(9):2129-2134.
  10. de Smet GHJ, Kroese LF, Menon AG, et al. Oxygen therapies and their effects on wound healing. Wound Repair Regen. 2017;25(4):591-608.
  11. Wang HT, Yuan JQ, Zhang B, Dong ML, Mao C, Hu D. Phototherapy for treating foot ulcers in people with diabetes. Cochrane Database Syst Rev. 2017;6(6):CD011979.
  12. Dos Santos CM, de Souza Lima da Silveira PR, da Rocha RB, et al. Adherence to self-care and quality of life of patients with diabetic foot ulcers treated with low-level laser therapy: an exploratory study. Adv Skin Wound Care. 2024;37(8):1-10.

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