NCT06028386 - 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)

Kapp D, Pfendler L, D'Oro L, Wolcott R
Early clinical performance of an adaptive self-assembling barrier scaffold in nonhealing chronic wounds: a review of six cases. Wounds. 2022 Jan;33(1):20-30. doi: 10.25270/wnds/2022.2030.
Koutsopoulos S
Self-assembling peptide nanofiber hydrogels in tissue engineering and regenerative medicine: Progress, design guidelines, and applications. J Biomed Mater Res A. 2016 Apr;104(4):1002-16. doi: 10.1002/jbm.a.35638. Epub 2016 Jan 25.
Rahmani G, Prats J, Norchi T, Kates S, McInerney V, Woods J, Kelly J
First Safety and Performance Evaluation of T45K, a Self-Assembling Peptide Barrier Hemostatic Device, After Skin Lesion Excision. Dermatol Surg. 2018 Jul;44(7):939-948. doi: 10.1097/DSS.0000000000001468.
Warriner RA, Snyder RJ, Cardinal MH
Differentiating diabetic foot ulcers that are unlikely to heal by 12 weeks following achieving 50% percent area reduction at 4 weeks. Int Wound J. 2011 Dec;8(6):632-7. doi: 10.1111/j.1742-481X.2011.00860.x. Epub 2011 Sep 23.

A Prospective Pilot Study Evaluating Wound Closure With the Application of AC5® Advanced Wound System in the Treatment of Diabetic Foot Ulcers

Clinical trial NCT06028386 - References