Low-intensity shockwave therapy in the treatment of diabetic nephropathy: a prospective Phase 1 study

Abstract

Background Low-intensity shockwave therapy (LI-SWT) is suggested as a therapy for promoting tissue regeneration. In pigs, it was recently found that LI-SWT improved renal function after ischaemic injury. Our objectives were to study glomerular filtration rate (GFR) and albuminuria in diabetic nephropathy (DN) after treatment with LI-SWT. The present pilot study reports on the clinical safety of LI-SWT in DN. Methods A total of 14 patients with diabetes mellitus and Stage 3 chronic kidney disease were recruited for this prospective, one-arm Phase 1 study. The patients were treated with six sessions of LI-SWT during a 3-week period. At each session, 3000 shockwaves were applied to each kidney with 0.265 mJ/mm2, extended focal size and 4 Hz. Follow-up visits were performed at 1, 3 and 6 months. Results In general, the treatment was well tolerated. Transient macroscopic haematuria was observed in three patients immediately after LI-SWT. The majority of patients experienced lower back tenderness lasting up to 2 days after treatment. There was no need for analgesic treatment. LI-SWT showed no negative effect on GFR and albuminuria. At baseline, median (interquartile range) GFR was 33.5 mL/min/1.73 m2 (27.8–43.8) compared with 36.0 mL/min/1.73 m2 (27.5–52.0) at 6 months follow-up. In parallel, median albuminuria was 256 mg/24 h (79–619) at baseline and tended to decrease to 137 mg/24 h (41–404) 6 months after LI-SWT. There was no statistical difference between baseline and follow-up results. Conclusions LI-SWT is a safe treatment for DN. Inclusion of more patients is needed to determine whether LI-SWT can improve renal functional outcomes.

Low-Energy Extracorporeal Shock Wave Therapy Ameliorates Kidney Function in Diabetic Nephropathy

“…This study suggests that low-energy ESWT is a novel noninvasive and effective treatment of DN. “Low-Intensity Shock Wave Therapy in the Treatment of Diabetic Nephropathy: A Prospective Phase 1 Study” by Skov-Jeppesen et al have results that did not demonstrate significant improvements of GFR and albuminuria [29]. The therapeutic effects were not as significant in the prospective phase 1 study by Skov-Jeppesen et al as those in the present study, the possible causes are different therapeutic settings including energy levels, number of shots, and frequency of treatment (Table 1).…”

Low-Intensity Shockwave Therapy (LI-ESWT) in Diabetic Kidney Disease: Results from an Open-Label Interventional Clinical Trial

“…In the present study, the side effects to LI-ESWT were comparable to our previous report. 25 In summary, LI-ESWT is clinically and biochemically safe in human diabetic kidney disease.…”

“…Preliminary results from the present trial were published in a safety report. 25 In the present analysis, the results were reported for a total of 28 patients. Only 14 patients were included in our preliminary safety report.…”

“…We previously reported preliminary data demonstrating the clinical safety of LI-ESWT in a subset of the cohort of patients with DKD. 25 The present study reports the full set of data after completing the trial with six-month follow-up on all included patients. The effect of LI-ESWT treatment on glomerular filtration rate (GFR), albuminuria, VEGF and NO excretion, blood pressure, and kidney injury markers is shown in the full cohort of patients with DKD.…”

Novel therapeutic strategies for renovascular disease

“…Importantly, this novel therapy does not cause detectable kidney injury in normal pigs, underscoring its safety (54). A recent pilot study in patients with diabetic nephropathy reported safety of SW therapy in human kidneys as well (58). Further studies are needed to define the optimal regimen of SW treatment in the ischemic kidney.…”