smartwave shock wave therapy clinical trial ED therapy and diabetic foot ulcers

smartwave shock wave therapy clinical trial ED therapy diabetic foot ulcers
Mini Shockwave therapy systemModel : BS-SWT2X
Product Description
Shock Wave Therapy Equipment, Radial Pulse Therapy (RSWT), ESWT extracorporeal shockwave therapy, also called Acoustic Wave Therapy Equipment, mainly for physical therapy treatment, sports injury and rehabitation treatment. A Non-Invasive Alternative to Orthopedic Surgery for tendon, musculoskeletal, soft tissue issues, non-union fractures to promote revascularization healing.
Radial Pulse Therapy (RSWT) is a newly FDA-approved treatment technique. It uses Shockwaves to mobilize the soft tissues of the body to achieve effects that are difficult or impossible to achieve by hand.
The available evidence regarding the efficacy of ESWT is conflicting. There is insufficient evidence regarding the durability of the treatment effects of ESWT. Patient selection criteria have not been adequately defined and optimal treatment parameters have not been established. Finally, in some studies, ESWT is no more effective than sham treatment in relieving pain.
BS-SWT200uses the latest electric-magnetic technology, without air-compressor, so comes with longer lifecycle, at the same time it can provide higher energy and frequency for better treatment result. From technical view, BS-SWT200 can reach energy from 60mj to 190mJ (5Bar), adjustable at stepping 10mJ(0.25Bar). Frequency ranges from 1Hz to 22Hz adjustable.

From the view of transmitter, BS-SWT200 has 5 different alloy made transmitters targeting to different depth and treatment disease.It includes 6mm, 15mm, 15mm unfocused, 25mm, 36mm, which covers most applications for physical treatments as well as aesthetics treatments.
Advantage and Specification of SmartWave:Long lifespan acoustic wave applicator, over 3 million shots before maintenance neededTi-alloy made applicator, can fully transfer energy to patients, double efficiency than 1st generationCan continuously work over 10000 shots without break, so as to provide excellent treatment resultMore than 38 pre-set treatment protocols, and support user defined protocolsEnergy from 60mJ to 190mJ, adjustable per 10mJ as stepping (equal to 0.25Bar to 5Bar)Frequency from 1Hz to 22Hz, adjustable per 1Hz as stepping
Extracorporeal shock wave therapy (ESWT), whether low energy, high energy or radial wave, is unproven and not medically necessary for all indications, including but not limited to the treatment of:
· Achilles tendonitis· Calcaneal spur· Calcific tendonitis of the shoulder (rotator cuff)
· Chronic plantar fasciitis (including plantar fibromatosis and plantar nerve lesion)
· Delayed or nonunion of fractures· Hammer toe· Lateral epicondylitis (tennis elbow)
· Medial epicondylitis (golfers elbow)· Tenosynovitis of the foot or ankle· Tibialis tendinitis· Wounds including ulcers
Highlights
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ESWT and foot care are effective therapy in the treatment of diabetic foot ulcers.•
ESWT is more effective than HBOT in wound healing of diabetic foot ulcers.•
ESWT improves wound healing and blood flow perfusion rates in diabetic foot ulcer.•
ESWT shows positive and better effects in short-term, than long-term outcomes in the treatment of diabetic foot ulcers.
Abstract
Diabetic foot ulcers (DFUs) are among the most common foot disorders with ulceration, infection, and gangrene that may ultimately lead to lower extremity amputation. The goals of treatment include the control of diabetes and proper shoe wear. An effective therapy and appropriate foot care are important in wound healing in DFUs. Recently, extracorporeal shockwave therapy (ESWT) was reported to significantly promote and accelerate the healing of complex soft tissue wounds as compared to the standard methods of treatment in DFUs. ESWT showed positive results in short-term and long-term outcomes in diabetic patients suffering from foot ulcers. In this article, we review the clinical results of ESWT in DFUs.2. Shockwave treatment for diabetic and non-diabetic foot ulcers
Recently, extracorporeal shockwave therapy (ESWT) has been successfully used in treatment of skin flaps to improve survival, diabetic and non-diabetic skin ulcers and acute or chronic soft-tissue wounds [10], [11], [12]. In 2005, Schaden et al. first reported the use of ESWT in the treatment of skin lesions of 102 patients (104 chronic foot ulcers) [11]. The success rates with complete healing was achieved in 74% and no adverse effect was observed. In this study the therapeutic spectrum did not include chronic diabetic ulcers. However, the authors conducted a further study comprising 175 patients with 177 chronic skin lesions in which they report of 74.5% complete healing [13]. In 2008, Saggini et al. applied ESWT in the management of chronic ulcers of the lower extremities including chronic posttraumatic, venous and diabetic ulcers [14]. The ESWT protocol consisted of 100 impulses per 1 cm2 of wound surface at an energy level of 0.037 mJ/mm2 each (Evotron, Lengwil, Switzerland). The treatment of focal volume was 10–15 mm in diameter and the total energy applied for each impulse was 3.5 mJ, with a frequency of 4 Hz or 240 impulses/min. The results indicated that 16 of thirty-two wounds healed completely with six sessions of shockwave treatment. In another study 30 patients with neuropathic DFUs were treated with ESWT every 72 h for three sessions with 100 impulses per 1 cm2 of wound surface delivered at each session at 0.03 mJ/mm2 energy flux density [15]. The results showed 53.33% complete wound closure in the ESWT group as compared to 33.33% of control patients. The healing time was 60.8 and 82.2 days for the ESWT and the control group, respectively (p < 0.001). In 2014, Omar et al. reported about thirty eight patients with 45 chronic DFUs who were randomly assigned to therapy [16]. The protocol of ESWT was used to treat each ulcer with 100 impulses/cm2 with an energy flux density of 0.11 mJ/mm2. This study showed completely healed ulcers in 33.3% (8 weeks) and 54% (20 weeks) in the ESWT group and 14.28% (8 weeks) and 28.5% (20 weeks) in the control group. The average healing time of ESWT group was significantly shorter than the control group (64.5 ± 8.06 days vs. 81.17 ± 4.35 days, respectively; p < 0.05). All studies concluded that ESWT is an effective treatment modality in the management of chronic DFUs without noteworthy side effects.
4. The long-term outcomes of ESWT in chronic foot ulcers
The long-term outcome (5-year follow-up) of chronic foot ulcers treated with ESWT was evaluated in a separate study [18]. The treatment dosage was ulcer size dependent and the number of impulses adjusted to the intended treatment area (cm2) x 8 with a minimum of at least 500 impulses at 0.11 mJ/mm2 energy flux density twice a week for six treatments in total. The entire study population consisted of 67 patients with 72 ulcers of which 38 patients with 40 ulcers suffered from diabetes mellitus (DM) whereas 29 patients with 32 ulcers were non-diabetic (non-DM). The results showed completely healed ulcers in 55.6% and 57.4%, irrespective of diabetes in the medical history, 48% and 43% in DM group, and 66% and 71% in non-DM group at 1 year and 5 years (p = 0.022 and p = 0.027), respectively. The tissue blood perfusion rates significantly increased after ESWT for up to 1 year compared to baseline values, but decreased in the interval from 1 to 5-year in both the DM and non-DM groups. However, the non-DM group showed significantly better tissue blood perfusion than the DM group at the 5-year time point (p = 0.04). This study clearly demonstrated that ESWT appears effective in chronic diabetic and non-diabetic foot ulcers. The results of this study showed that in chronic foot ulcers ESWT may be linked to the improvement in tissue blood perfusion and thus tissue regeneration. Therefore, repetitive treatments with ESWT may provide an intermittent booster effect for tissue viability and regeneration and potentially prolong the positive effects of shockwave treatment.5. Conclusion
ESWT appears effective in the treatment of DFUs. It is easy to apply, practically without undesired side effects and cost effective compared to other treatment modalities. However more research and larger series of randomized controlled clinical trials are needed to confirm the efficacy of ESWT for DFUs. Many factors may directly or indirectly affect the results such as the optimal timing and dosage of treatment as well as the frequency of ESWT in the management of diabetic foot ulcer. ESWT may be a good alternative modality when conventional treatment methods have failed.

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BENEFITS OF EXTRACORPOREAL SHOCK WAVE THERAPY
The Extracorporeal Shock Wave Therapy offers many advantages to potential patients. Unlike medications, Extracorporeal Shock Wave Therapy doesn’t require people to take oral drugs or shots prior to sex. It’s also non-invasive, so there is no surgery involved and there are few side effects to the treatments. There is also no downtime with the treatments, and each session only takes 20 minutes. Best of all, patients will only need 10 treatments for lasting results.
Many men have vasculogenic ED, which is caused by a lack of blood flow to the sexual organ. Extracorporeal Shock Wave Therapy can help them as well as diabetic men whose condition contributes to their ED. It has also been used to treat those who are both responsive and unresponsive to ED medication.
RESULTS FROM CLINICAL TRIALS
Current studies of patients using ESWT indicate the benefits can last up to 2 years or longer, and 2 out of 3 men with vascular or diabetic Erectile Dysfunction will have favorable results. So far, there have been more than 40 studies conducted on ESWT, most of which have shown promising results. Up to 75% of men who were taking oral medication to treat Erectile Dysfunction were able to stop taking the medication after ESWT and perform intercourse successfully. Around 72% of people who were unresponsive to oral Erectile Dysfunction medication were able to perform intercourse after ESWT along with oral drugs. Likewise, the treatments have been well-tolerated by patients overall. Many patients have found their erections had improved and they were able to have intercourse successfully.

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smartwave shock wave therapy clinical trial ED therapy diabetic foot ulcers