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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/cm(2) impulses of shockwave at 0.11 mJ/cm(2) 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.
BACKGROUND: Diabetes is becoming one of the most common chronic diseases, and ulcers are its most serious complication. Beginning with neuropathy, the subsequent foot wounds frequently lead to lower extremity amputation, even in the absence of critical limb ischemia. In recent years, some researchers have studied external shock wave therapy (ESWT) as a new approach to soft tissue wound healing. The rationale of this study was to evaluate if ESWT is effective in the management of neuropathic diabetic foot ulcers. METHODS: We designed a randomized, prospective, controlled study in which we recruited 30 patients affected by neuropathic diabetic foot ulcers and then divided them into two groups based on different management strategies. One group was treated with standard care and shock wave therapy. The other group was treated with only standard care. The healing of the ulcers was evaluated over 20 weeks by the rate of re-epithelization. RESULTS: After 20 weeks of treatment, 53.33% of the ESWT-treated patients had complete wound closure compared with 33.33% of the control patients, and the healing times were 60.8 and 82.2 days, respectively (p<0.001). Significant differences in the index of the re-epithelization were observed between the two groups, with values of 2.97 mm2/die in the ESWT-group and 1.30 mm2/die in the control group (p< 0.001). CONCLUSIONS: Therefore, ESWT may be a useful adjunct in the management of diabetic foot ulceration
Extracorporeal Shock Wave treatment is a well established treatment in orthopedics. Considerable success has been reported after treatment of various soft tissue pathologies (Tendinitis, heel spur etc). In recent years, encouraging results have been reported concerning the effect of the shock-wave on chronic wounds. It has been reported that healing time can be considerably shortened if shock-waves are applied to the wound in addition to conventional wound treatment. Yet, randomized, controlled, prospective trials are missing.
In this study, the effect of shock-waves on diabetic foot ulcer shall be assessed.
The study is composed of 5 groups of which 4 groups receive shock wave treatments (each with a different protocol). One group serves as an untreated control group. All groups get standardized wound treatment and wound dressing. That shock-wave application protocol that shows the best results (rate of completely healed ulcer, most decrease of ulcer size) shall be tested in a further, sufficiently dimensioned, two-armed, randomized controlled trial (RCT).
Management of chronic ulcers in the lower extremities is still a challenge for patients and health providers. Recent studies showed extracorporeal shock waves (ESW) as effective in stimulating growth factors, inducing angiogenesis and healing of fractures and injuries. This study was planned to investigate the opportunity of introducing the ESW in the treatment of chronic wounds. Thirty consecutive patients with chronic posttraumatic, venous and diabetic ulcers, unresponsive to conservative or advanced dressing treatments, were counseled about the use of ESW as alternative treatment for their wounds. Thirty-two wounds were treated and 16 wounds healed completely within six sessions of ESW. In all of the nonhealed wounds, decrease of the amount of exudates, increased percentage of granulation tissue compared with fibrin/necrotic tissue and decrease of wounds' size were statistically significant after four to six sessions of ESW (p < 0.01). Significant decrease of pain was reported (p < 0.001). Comparison with a control group of 10 patients with chronic ulcer treated on the basis of regular dressings confirmed the statistical significant improvement in the healing process (p < 0.01). ESW therapy seems to be a safe, feasible and cost-effective treatment for chronic ulcers in the lower extremities. Further research and clinical trials are necessary to evaluate dose and time intervals of sessions to standardize a protocol of treatment in the management of chronic wound
Management of chronic diabetic foot skin ulcers require multidisciplinary approaches including diabetic control, wound care, antibiotic, shoe wear off-loading, and surgery in selected cases. The results are inconsistent and irregular, and most studies reported unsatisfactory results. Many adjunctive therapies are implemented in the care of chronic diabetic foot ulcers including hyperbaric oxygen therapy (HBO), ultrasound, recombinant human platelet-derived growth factor-BB (rPDGF-BB), vacuum assisted wound closure (VAWC) and acellular matrix. HBO is the most commonly utilized at the investigators institution. Mixed results of HBO in chronic diabetic foot ulcers are reported. Several studies reported that the beneficial effects of HBO, but none showed universal success. Therefore, the development of a new effective method of treatment for chronic diabetic ulcers is extremely valuable. Extracorporeal shockwave therapy (ESWT) acts as mechanotransduction that produces the therapeutic benefits through complex biological pathways including neovascularization and tissue regeneration. ESWT also showed bacteriostatic effects in experiments. Some studies reported the effectiveness of ESWT in acute and chronic soft tissue wounds. Others reported effectiveness of ESWT in chronic ulcers with 50% completely healed with 6 sessions of treatment. With this background, it appears that ESWT may be effective in the treatment of chronic diabetic foot ulcers. The purpose of this study is to evaluate the efficacy of ESWT in chronic foot ulcers, and to compared with that treated with HBO, and to study the molecular and blood flow perfusion before and after ESWT.
OBJECTIVE: This study compared the effectiveness of extracorporeal shockwave therapy (ESWT) and hyperbaric oxygen therapy (HBOT) in chronic diabetic foot ulcers.
PATIENTS AND METHODS: The ESWT group (39 patients/44 feet) received shockwave therapy twice per week for total six treatments. The HBOT group (38 patients/40 feet) received hyperbaric oxygen therapy daily for total 40 treatments. Evaluations included clinical assessment, blood flow perfusion scan and histopathological examination.
RESULTS: The overall clinical results showed completely healed ulcers in 57% and 25% (P=0.003); ≥50% improved ulcers in 32% and 15% (P=0.071); unchanged ulcers in 11% and 60% (P<0.001) and none worsened for the ESWT and the HBOT group respectively. The blood flow perfusion rates were comparable between the two groups before treatment (P=0.245), however, significant differences were noted after treatment favoring the ESWT group (P=0.002). Histopathological examination revealed considerable increases in cell proliferation and decreases in cell apoptosis in the ESWT group as compared to the HBOT group.
CONCLUSION: ESWT is more effective than HBOT in chronic diabetic foot ulcers. ESWT-treated ulcers showed significant improvement in blood flow perfusion rate and cell activity leading to better healing of the ulcers relative to HBOT in chronic diabetic foot ulcers.
This case study illustrates the option of treating poorly healing diabetic wounds with shock waves. A case study was performed with a 75-year-old male patient with diabetic gangrene of both feet facing the prospect of imminent amputation. On a visual analogue pain scale (0-10), the patient reported a pain score of between 7 and 9. In the past, focused shock waves have been used to successfully treat poorly healing wounds and in this case are adopted for the treatment of severe peripheral arterial occlusive disease. Over a time interval of nearly a year, 11 treatments were delivered. At the end of the treatment the necrotic areas vanished. By then the pain score decreased to 2 and no further pain medication was needed.
Re: Extracorporeal Shockwave Treatment for Chronic Diabetic Foot Ulcers
I know ESWT but why 11 ?? To helps with re-vascularisation to an ulcer border - help reduce the size of the wound.
I assume strong antibiotics and debridement of the gangrenous tissue would have occurred as well.
Once the gangrene was eliminated form the body and specialised wound dressings applied it would be then possible for the wound to close.
Diabetic ulcers are the slowest to heal.
What type of pain medication was used? Aspro, Dispirin, Oxycontin, ???
Lacking on a lot of the details
This study investigated the molecular changes of extracorporeal shockwave therapy (ESWT) and hyperbaric oxygen therapy (HBOT) in chronic diabetic foot ulcers.
A cohort study consisted of 39 patients (44 ulcers) in the ESWT group and 38 patients (40 ulcers) in the HBOT group with similar demographic characteristics. The ESWT group received shockwave therapy twice per week for total six treatments. The HBOT group received hyperbaric oxygen therapy daily for total 20 treatments. Biopsy was performed from the periphery of the ulcer before and after treatment. The specimens were immuno-stained, and the positive immuno-activities of vWF, VEGF, eNOS, PCNA, EGF and TUNEL expressions were examined and quantified microscopically.
Significant increases in vWF, VEGF, eNOS, PCNA and EGF expressions and a decrease in TUNEL expression were noted after ESWT (P < 0.05), whereas the changes after HBOT were statistically not significant (P > 0.05). The differences of vWF, VEGF, eNOS, PCNA, EGF and TUNEL expressions between the two groups were comparable before treatment (P > 0.05), however, the differences became statistically significant after treatment (P < 0.05) favoring the ESWT group.
ESWT showed significant increases in angiogenesis and tissue regeneration over HBOT in diabetic foot ulcers.
Low-energy extracorporeal shock wave (LE-ESW) treatment has been shown to accelerate wound repair; however, the mechanisms of treatment remain unclear. In the present study, we addressed the role of endothelial nitric oxide synthase (eNOS). A single LE-ESW treatment accelerated the healing of wounds in diabetic mice caused by the injection of streptozotocin. This accelerated healing was accompanied by the increased expression of eNOS and vascular endothelial growth factor (VEGF) and the generation of new vessels at the wound tissues. These results raised the possibility that eNOS may be involved in the beneficial effects of LE-ESW treatment. To address this possibility, we compared the effects of this treatment between mice with a genetic disruption of eNOS knockout (eNOS-KO mice) and wild-type (WT) control mice. Interestingly, the LE-ESW-induced acceleration of wound closure and the increase in VEGF expression and neovascularization was significantly attenuated in eNOS-KO mice compared with WT mice. Considered collectively, these results showed that eNOS was induced at the wound tissues by LE-ESW treatment and played a critical role in the therapeutic effects of this treatment by accelerating the wound healing by promoting VEGF expression and neovascularization.
Recent studies showed that extracorporeal shockwave therapy (ESWT) is effective in the treatment of chronic foot ulcers in short term. However, the long-term effects of ESWT in chronic foot ulcers are unknown. The purpose of this study was to evaluate the long-term outcomes of ESWT in chronic foot ulcers with 5-y follow-up.
The study cohort consisted of 67 patients with 72 ulcers including 38 patients with 40 ulcers in the diabetes mellitus (DM) group and 29 patients with 32 ulcers in the non-diabetes mellitus (non-DM) group. Each patient received ESWT to the affected foot twice per week for 3 wk for a total of six treatments. The evaluations included clinical assessment for the ulcer status, local blood flow perfusion, and analysis of mortality and morbidity.
The results showed completely healed ulcers in 55.6% and 57.4% of total series, 48% and 43% of DM group, and 66% and 71% of non-DM group at 1 and 5 y (P = 0.022 and P = 0.027), respectively. The mortality rate was 15% in total series, 24% in DM group, and 3% in non-DM group (P = 0.035). The rate of amputation was 11% in total series, 17% in DM group, and 3.6% in non-DM group (P = 0.194). The blood flow perfusion rate significantly increased after ESWT for up to 1 yr but decreased from 1-5 y in both groups. However, the non-DM group showed significantly better blood flow perfusion than the DM group at 5 y (P = 0.04).
ESWT appears effective in chronic diabetic and nondiabetic foot ulcers. However, the effects decreased from 1-5 y after treatment.
Foot ulcers are a feared complication among diabetic patients. The ulcers can cause pain, discomfort and reduced quality of life. The development of foot ulcers places the patients at a risk of amputation. In the Danish Health Care System a substantial effort is done to prevent and treat diabetic foot ulcers. A constant research of how to treat these wounds is ongoing. The goal is to optimize wound healing and prevent amputations.
Extracorporeal shockwave therapy (ESWT) involves the use of a device that generates low-energy shockwaves through a headpiece, which is placed on the skin of the patient. A small amount of energy will be deposited in the tissue when shockwaves are applied. This stimulates the cells to produce substances that generate new vessels. No side effects to ESWT have been shown.
The investigators want to test whether shockwave therapy can improve wound healing among diabetic patients with foot ulcers.
The investigators hypothesize that shockwave therapy accelerates ulcer healing, increases blood flow, reduces pain, and has no side effects.
Patients who are interested in participation will be included in the study and divided by randomization into two groups of equal size. The first group is treated with ESWT in combination with regular guideline treatment. The second group is set up as control group and will only receive regular guideline treatment. The participants are examined in different ways to evaluate whether ESWT helps the healing of foot ulcers. The investigators want to measure toe blood pressure, tissue oxygen pressure and foot sense of touch. The foot ulcers are tested for infection before, during and after the treatment. The size of the ulcers are measured and photographed each time. The investigators will count how many foot ulcers that are completely healed during the test period and measure the sizes of the remaining foot ulcers. The patients are asked to evaluate pain related to the foot ulcer. Data concerning participants' co morbidities and use of analgesic drugs are obtained from the patient journal and by patient interview.
ESWT should be considered a supplement to existing clinical guidelines in wound management if shown to effectively help healing of diabetic foot ulcers. Improved healing should reduce the heavy workload on care and treatment regarding to these wounds. Hopefully, the frequency of amputations among diabetic patients will decline by implementing new treatment options for the diabetic foot.