NCT03369756 - 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)

Andriessen AE, Eberlein T
Assessment of a wound cleansing solution in the treatment of problem wounds. Wounds. 2008 Jun;20(6):171-5.
Augustin M, Baade K, Herberger K, et al
Use of the Wound-QoL instrument in routine practice: feasibility, validity, and development of an implementation tool. Wound Medicine. 2014;5:4-8
Blome C, Baade K, Debus ES, Price P, Augustin M
The "Wound-QoL": a short questionnaire measuring quality of life in patients with chronic wounds based on three established disease-specific instruments. Wound Repair Regen. 2014 Jul-Aug;22(4):504-14. doi: 10.1111/wrr.12193.
Frykberg RG, Banks J
Challenges in the Treatment of Chronic Wounds. Adv Wound Care (New Rochelle). 2015 Sep 1;4(9):560-582. Review.
Leaper DJ, Schultz G, Carville K, Fletcher J, Swanson T, Drake R
Extending the TIME concept: what have we learned in the past 10 years?(*). Int Wound J. 2012 Dec;9 Suppl 2:1-19. doi: 10.1111/j.1742-481X.2012.01097.x. Review.
McCarty SM, Percival SL
Proteases and Delayed Wound Healing. Adv Wound Care (New Rochelle). 2013 Oct;2(8):438-447. Review.
Richmond NA, Maderal AD, Vivas AC
Evidence-based management of common chronic lower extremity ulcers. Dermatol Ther. 2013 May-Jun;26(3):187-96. doi: 10.1111/dth.12051. Review.
Romanelli M, Dini V, Barbanera S, Bertone MS
Evaluation of the efficacy and tolerability of a solution containing propyl betaine and polihexanide for wound irrigation. Skin Pharmacol Physiol. 2010;23 Suppl:41-4. doi: 10.1159/000318266. Epub 2010 Sep 8.

A Prospective Study of Quality of Life in Patients With Chronic Leg Wound(s) Treated With Prontosan® Wound Irrigation Solution and Prontosan® Wound Gel

Details for clinical trial NCT03369756

Clinical trial NCT03369756 - References