Modified Platform Trial Assessing Multiple CAMPs and SOC vs SOC Alone in the Treatment of Hard-to-Heal DFUs

The purpose of this study is to evaluate the efficacy of four dehydrated complete human placental membrane, also defined as Cellular, Acellular, Matrix-like Products/skin substitutes, plus SOC versus SOC alone in achieving complete closure of hard-to-heal diabetic foot ulcers over 12 weeks using a modified platform trial design.

NCT Number	NCT06449638
Lead Sponsor	StimLabs Collaborators: SerenaGroup, Inc.
Conditions	Diabetic Foot Ulcer (DFU), Ulcer Foot, Diabetic Foot, Foot Ulcer
Enrollment	272 participants
Start Date	2024-07-16
Primary Completion	2026-11 (estimated)
Study Completion	2026-12 (estimated)
Updated on ClinicalTrials.gov	2026-03-02