NCT02451722 - Clinical Trial References

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Citation(s)

Boulton AJ, Vileikyte L, Ragnarson-Tennvall G, Apelqvist J
The global burden of diabetic foot disease. Lancet. 2005 Nov 12;366(9498):1719-24. Review.
Bus SA, Valk GD, van Deursen RW, Armstrong DG, Caravaggi C, Hlavácek P, Bakker K, Cavanagh PR
The effectiveness of footwear and offloading interventions to prevent and heal foot ulcers and reduce plantar pressure in diabetes: a systematic review. Diabetes Metab Res Rev. 2008 May-Jun;24 Suppl 1:S162-80. doi: 10.1002/dmrr.850. Review.
Pecoraro RE, Reiber GE, Burgess EM
Pathways to diabetic limb amputation. Basis for prevention. Diabetes Care. 1990 May;13(5):513-21.
Pham H, Armstrong DG, Harvey C, Harkless LB, Giurini JM, Veves A
Screening techniques to identify people at high risk for diabetic foot ulceration: a prospective multicenter trial. Diabetes Care. 2000 May;23(5):606-11.
Prompers L, Huijberts M, Apelqvist J, Jude E, Piaggesi A, Bakker K, Edmonds M, Holstein P, Jirkovska A, Mauricio D, Ragnarson Tennvall G, Reike H, Spraul M, Uccioli L, Urbancic V, Van Acker K, van Baal J, van Merode F, Schaper N
High prevalence of ischaemia, infection and serious comorbidity in patients with diabetic foot disease in Europe. Baseline results from the Eurodiale study. Diabetologia. 2007 Jan;50(1):18-25. Epub 2006 Nov 9.

Evaluation of Pressure Distribution of Kyboot Shoes in Comparison to Other Foot Wear in Diabetic Patients and in Healthy Subjects

Clinical trial NCT02451722 - References