Wound healing/plastic surgery
Extracorporeal Shockwave Treatment for Chronic Diabetic Foot Ulcers

https://doi.org/10.1016/j.jss.2008.01.026Get rights and content

Background

This prospective study compared extracorporeal shockwave treatment (ESWT) with hyperbaric oxygen therapy (HBO) in chronic diabetic foot ulcers.

Patients and methods

Seventy-two patients with 72 chronic diabetic foot ulcers were randomly divided into two groups of similar demographics with 34 patients with 36 ulcers in the ESWT group and 36 patients with 36 ulcers in the HBO group. Patients in the ESWT group received 300 + 100/cm2 impulses of shockwave at 0.11 mJ/cm2 energy flux density every 2 wk for 6 wk, whereas patients in the HBO group received HBO daily for 20 treatments. The evaluations included clinical assessment of the ulcers with photo-documentation, blood flow perfusion scan, bacteriological examination, histological study, and immunohistochemical analysis.

Results

The overall results showed completely healed in 31%, improved in 58%, and unchanged in 11% for the ESWT group and 22% completely healed, 50% improved, and 28% unchanged for the HBO group. The ESWT group showed significantly better clinical results and local blood flow perfusion, higher cell concentration, and activity than the HBO group. On immunohistochemical analysis, the ESWT group demonstrated significant increases in endothelial nitric oxide synthase, vessel endothelial growth factor, and proliferation cell nuclear antigen expressions and a decrease in transference-mediated digoxigenin-deoxy-UTP nick end-labeling expression than the HBO group.

Conclusions

ESWT appears to be more effective than HBO in chronic diabetic foot ulcers.

Introduction

Chronic diabetic foot ulcer is caused by small-vessel occlusion, usually compounded by neuropathy and infection [1, 2, 3, 4, 5, 6]. Despite the changes in guidelines and classification, the treatment of a diabetic foot ulcer remains challenging and controversial [7, 8, 9, 10, 11, 12]. Angioplasty or bypass surgery is generally ineffective in small-vessel disease and amputation becomes inevitable due to persistent critical limb ischemia, soft-tissue infection, and impaired wound healing with osteomyelitis [13, 14]. Skin grafts with different techniques are performed with the intention to heal the ulcers in selected cases [15]. Many adjunctive therapies are designed for the care of chronic diabetic foot ulcers including hyperbaric oxygen therapy (HBO), ultrasound, recombinant human platelet-derived growth factor-BB, vacuum-assisted wound closure, and acellular matrix with HBO being the most commonly used [13, 16, 17, 18, 19, 20, 21, 22]. The results of different treatment regimens of surgical and nonsurgical are inconsistent, and most studies reported limited success in selected series [19, 20, 21, 22, 23]. Therefore, the development of a new effective and noninvasive method of treatment for chronic diabetic foot ulcer is extremely valuable.

Recently, extracorporeal shockwave treatment (ESWT) was introduced for the treatment of chronic refractory diabetic and nondiabetic skin ulcers, and acute and chronic soft-tissue wounds with encouraging early results in short-term follow-up [24, 25, 26, 27]. The purpose of this study was to evaluate the efficacy of ESWT in the treatment of chronic diabetic foot ulcers and to compare the results with that of HBO and to investigate the regeneration effects with local blood flow perfusion, histomorphological examination, and immunohistochemical analysis.

Section snippets

Patients and Methods

The Institutional Review Board on Human Studies of our hospital approved this study. The declaration of Helsinki protocols were followed, and patients gave their written informed consent prior to participation in the study. The inclusion criteria included patients with recurrent chronic diabetic ulcers of the foot for more than 3 mo duration. Patients with deep wound sepsis or gangrenous changes usually required surgical debridement and wound care until the ulcers became stable but nonhealing

Results

The overall results of treatment are summarized in Table 2. The results showed completely healed in 31%, improved in 58%, and unchanged in 11% for the ESWT group and 22% completely healed, 50% improved, and 28% unchanged for the HBO group (P < 0.001). More than 50% improvement of the ulcer was observed in 89% of ESWT group and 72% of HBO group (P < 0.001). ESWT appears to be more effective than HBO in the treatment of diabetic foot ulcers.

In histomorphological examination, the microscopic

Discussion

The causes of diabetic foot ulcers are multifactorial, including ischemia, hypoxia, neuropathy, and infection, and they often coexist [3, 4, 5, 14, 28]. The management of chronic diabetic foot ulcers require multidisciplinary approaches including control of blood sugar, antibiotics, shoe wear, wound care, and surgery in selected cases with the primary goal to control the diabetic mellitus and to avoid complications [2, 3, 4, 5, 19, 28]. In some cases, amputation becomes inevitable due to

Acknowledgments

Funds were received in total or partial support for the research or clinical study presented in this article. The funding sources were from the National Science Council (95-2314-B-182A-081), Tissue Regeneration Technologies, and National Health Research Institute (NHRI-EX96-9423EP).

References (35)

  • R.M. Macfarlane et al.

    Factors contributing to the presentation of diabetic foot ulcers

    Diabet Med

    (1997)
  • J. Mason et al.

    A systematic review of foot ulcer in patients with type 2 diabetes mellitusII, treatment

    Diabet Med

    (1999)
  • S. O'Meara et al.

    Systematic reviews of wound care management; (3) anti-microbial agents for chronic wounds; (4) diabetic foot ulceration

    Health Technol Assess

    (2000)
  • B.A. Perkins et al.

    Simple screening tests for peripheral neuropathy in the diabetes clinic

    Diabetes Care

    (2001)
  • D.G. Armstrong et al.

    Validation of a diabetic wound classification system

    Diabetes Care

    (1998)
  • R.M. Macfarlane et al.

    Classification of diabetic foot ulcers: The S (AD) SAD system

    Diabetic Foot

    (1999)
  • N.C. Schaper et al.

    The international consensus and practical guidelines on the management and prevention of the diabetic foot

    Current Diabetes Rep

    (2003)
  • Cited by (82)

    • Extracorporeal Shockwave Therapy for Diabetic Foot Ulcers: A Systematic Review and Meta-Analysis

      2019, Annals of Vascular Surgery
      Citation Excerpt :

      When presenting results of the study, it was unclear when wound measurements were taken and whether the results obtained were after one course of ESWT or repeated courses of ESWT.21 The study also excluded 4 patients because of poor follow-up but did not allude the reasons for poor follow-up.21 All studies recruited outpatients from single centers in secondary care, excluding patients managed by general practitioners/family doctors and community health-care teams.

    View all citing articles on Scopus
    View full text