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Abstract
Information on clinical trials on the use of stem cells for the therapy of patients with diabetic foot syndrome is provided according to the ClinicalTrials.gov database. As of April 20, 2020, www.ClinicalTrials.gov posted information on 37 clinical trials on the use of stem cells for the therapy of patients with diabetic foot syndrome. The average duration of these clinical trials is 2 years and 7 months (8 months to 6 years). Current status of trials: «unknown» — 18 trials,
«completed» — 10 trials, «recruiting» — 5 trials, «active, no recruiting» — 2 trials, «not yet recruiting» and «withdrawn» — 1 trial each. Most clinical trials are conducted in China (8 trials), United States of America (6 trials), Republic of Korea (4 trials), Spain and Germany (3 trials each). 35 clinical trials were interventional, 2 trials were observational prospective case-only trials on the safety of the drug. The total number of clinical trials participants was 2438 (minimum — 4, maximum — 250, average — 66). The distribution for 22 clinical trials was randomized and 3 was notrandomized; no information available
for 12 trials. By type of intervention model, 23 clinical trials were parallel assignment, 11 were single group assignment and 1 were sequential assignment. In 25 clinical trials, masking was not applied, 5 trials were single blind masking, 3 trials were double blind masking, 1 trials was triple blind masking 1 study was quadruple blind masking; no information available for 2 trials. The primary purpose of 35 clinical trials was treatment. The following study phases were indicated for 31 clinical trials: early phase I (previously phase 0) for 2 trials, phase I for 12 studies, phase I/II (combination of phases I and II) for 9 trials, phase II for 6 trials, phase II/III (combination of phases II and III) for 1 trial, phase III for 1 trial; in 4 trials phase determination was not applied and in 2 trials no information was available. A review of publications based on 7 clinical trials is presented.
References
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