NCT03916211|UnknownEarly Phase 1DMC
Loading search results
Sponsor study identifier
interventional
60
0 countries
N/A
Study Start
April 20, 2019
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Primary Completion
January 31, 2020
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
March 31, 2020
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
March 31, 2020
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
April 10, 2019
Actual (reported)April 16, 2019
Actual (reported)April 20, 2019
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
January 31, 2020
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
March 31, 2020
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
ulcer healing rate
Ulcer healing rate = number of cases of complete wound healing / total number of ulcers in this group
up to 4 weeks
amputation rate
Amputation rate = number of amputations / total number of amputations in this group
up to 4 weeks
ultrasound
2 weeks
ABI(ankle brachial index)
2weeks
TcPO2（Transcutaneous oxygen pressure）
2 weeks
CTA(Computed Tomography angiography)
up to 4 weeks
Rutherford Classification
2 weeks
Diabetic foot routine treatment without intervention
On the basis of routine treatment of diabetic foot, adipose stem cells will be added to treat diabetic foot
intramuscular injection of adipose stem cells treat diabetic foot
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Lu Debin, Jiang Youzhao, Liang Ziwen, Li Xiaoyan, Zhang Zhonghui, Chen Bing.Autologous transplantation of bone marrow mesenchymal stem cells on diabetic patients with lower limb ischemia.Journal of Medical Colleges of PLA 2008;23:106-115
Carlin JB, Doyle LW. Sample size. J Paediatr Child Health. 2002 Jun;38(3):300-4. doi: 10.1046/j.1440-1754.2002.00855.x. No abstract available.
Al-Delaimy WK, Merchant AT, Rimm EB, Willett WC, Stampfer MJ, Hu FB. Effect of type 2 diabetes and its duration on the risk of peripheral arterial disease among men. Am J Med. 2004 Feb 15;116(4):236-40. doi: 10.1016/j.amjmed.2003.09.038.
Li Xue, ph.D
Shanghai 10th People'sHospital
First Submitted
April 10, 2019
First Posted
April 16, 2019
Study Start
April 20, 2019
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Primary Completion
January 31, 2020
Contact the study team to confirm eligibility.
Khattab AD, Ali IS, Rawlings B. Peripheral arterial disease in diabetic patients selected from a primary care setting: Implications for nursing practice. J Vasc Nurs. 2005 Dec;23(4):139-48. doi: 10.1016/j.jvn.2005.09.005.
Rathur HM, Boulton AJ. The diabetic foot. Clin Dermatol. 2007 Jan-Feb;25(1):109-20. doi: 10.1016/j.clindermatol.2006.09.015.
Dick F, Diehm N, Galimanis A, Husmann M, Schmidli J, Baumgartner I. Surgical or endovascular revascularization in patients with critical limb ischemia: influence of diabetes mellitus on clinical outcome. J Vasc Surg. 2007 Apr;45(4):751-61. doi: 10.1016/j.jvs.2006.12.022. Epub 2007 Feb 15.
Engelhardt M, Bruijnen H, Scharmer C, Jezdinsky N, Wolfle K. Improvement of quality of life six months after infrageniculate bypass surgery: diabetic patients benefit less than non-diabetic patients. Eur J Vasc Endovasc Surg. 2006 Aug;32(2):182-7. doi: 10.1016/j.ejvs.2006.02.007. Epub 2006 Mar 29.
Huang P, Li S, Han M, Xiao Z, Yang R, Han ZC. Autologous transplantation of granulocyte colony-stimulating factor-mobilized peripheral blood mononuclear cells improves critical limb ischemia in diabetes. Diabetes Care. 2005 Sep;28(9):2155-60. doi: 10.2337/diacare.28.9.2155.
Humpert PM, Bartsch U, Konrade I, Hammes HP, Morcos M, Kasper M, Bierhaus A, Nawroth PP. Locally applied mononuclear bone marrow cells restore angiogenesis and promote wound healing in a type 2 diabetic patient. Exp Clin Endocrinol Diabetes. 2005 Oct;113(9):538-40. doi: 10.1055/s-2005-872886.
Canizo MC, Lozano F, Gonzalez-Porras JR, Barros M, Lopez-Holgado N, Briz E, Sanchez-Guijo FM. Peripheral endothelial progenitor cells (CD133 +) for therapeutic vasculogenesis in a patient with critical limb ischemia. One year follow-up. Cytotherapy. 2007;9(1):99-102. doi: 10.1080/14653240601034708.
Kern S, Eichler H, Stoeve J, Kluter H, Bieback K. Comparative analysis of mesenchymal stem cells from bone marrow, umbilical cord blood, or adipose tissue. Stem Cells. 2006 May;24(5):1294-301. doi: 10.1634/stemcells.2005-0342. Epub 2006 Jan 12.
De Ugarte DA, Morizono K, Elbarbary A, Alfonso Z, Zuk PA, Zhu M, Dragoo JL, Ashjian P, Thomas B, Benhaim P, Chen I, Fraser J, Hedrick MH. Comparison of multi-lineage cells from human adipose tissue and bone marrow. Cells Tissues Organs. 2003;174(3):101-9. doi: 10.1159/000071150.
Zuk PA, Zhu M, Ashjian P, De Ugarte DA, Huang JI, Mizuno H, Alfonso ZC, Fraser JK, Benhaim P, Hedrick MH. Human adipose tissue is a source of multipotent stem cells. Mol Biol Cell. 2002 Dec;13(12):4279-95. doi: 10.1091/mbc.e02-02-0105.
Gimble JM, Katz AJ, Bunnell BA. Adipose-derived stem cells for regenerative medicine. Circ Res. 2007 May 11;100(9):1249-60. doi: 10.1161/01.RES.0000265074.83288.09.
Wei Y, Hu H, Wang H, Wu Y, Deng L, Qi J. Cartilage regeneration of adipose-derived stem cells in a hybrid scaffold from fibrin-modified PLGA. Cell Transplant. 2009;18(2):159-70. doi: 10.3727/096368909788341261.
This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
March 31, 2020
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
April 16, 2019
Record last verified: 2019-04
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.
Source retrieved: