NCT03626623 - 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)

Bann CM, Fehnel SE, Gagnon DD
Development and validation of the Diabetic Foot Ulcer Scale-short form (DFS-SF). Pharmacoeconomics. 2003;21(17):1277-90.
Chen YH, DeMets DL, Lan KK
Increasing the sample size when the unblinded interim result is promising. Stat Med. 2004 Apr 15;23(7):1023-38.
Dumville JC, O'Meara S, Deshpande S, Speak K
Hydrogel dressings for healing diabetic foot ulcers. Cochrane Database Syst Rev. 2013 Jul 12;(7):CD009101. doi: 10.1002/14651858.CD009101.pub3. Review.
Margolis DJ, Kantor J, Berlin JA
Healing of diabetic neuropathic foot ulcers receiving standard treatment. A meta-analysis. Diabetes Care. 1999 May;22(5):692-5.
Rice JB, Desai U, Cummings AK, Birnbaum HG, Skornicki M, Parsons NB
Burden of diabetic foot ulcers for medicare and private insurers. Diabetes Care. 2014;37(3):651-8. doi: 10.2337/dc13-2176. Epub 2013 Nov 1. Erratum in: Diabetes Care. 2014 Sep;37(9):2660.
Wu L, Norman G, Dumville JC, O'Meara S, Bell-Syer SE
Dressings for treating foot ulcers in people with diabetes: an overview of systematic reviews. Cochrane Database Syst Rev. 2015 Jul 14;(7):CD010471. doi: 10.1002/14651858.CD010471.pub2. Review.
Yazdanpanah L, Nasiri M, Adarvishi S
Literature review on the management of diabetic foot ulcer. World J Diabetes. 2015 Feb 15;6(1):37-53. doi: 10.4239/wjd.v6.i1.37. Review.

A Prospective, Randomized, Controlled Trial Comparing Cytal Wound Matrix 1-Layer to Standard of Care (SOC) in the Management of Diabetic Foot Ulcers (DFUs)

Details for clinical trial NCT03626623

Clinical trial NCT03626623 - References