Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 3:16 PM
Ignite Modification Date:
2025-12-24 @ 3:16 PM
NCT ID:
NCT04281992
Brief Summary:
This is a two-part phase 1/2A study performed in diabetic foot ulcer (DFU) patients with chronic non-healing wounds to investigate the safety and efficacy of AUP1602-C.
Detailed Description:
Study AP-W-CLI-2018-8 is the first clinical study of AUP1602-C in humans. It is a Phase 1/2A clinical study to evaluate the safety, tolerability and efficacy of a single and repeated doses of AUP-16 as topical treatment of DFU. The Phase 1 part will be a multicenter, open-label, non-randomized, uncontrolled dose-finding study with sequential dose escalations performed in dose cohorts comparing three doses of AUP-16 administered three times per week (low, medium, and high dose cohorts). This part will consist of four sequentially recruited cohorts. It is expected that a minimum of 15 patients may be required to determine the RP2D in phase 1 part.
The Phase 2A part, an extension of the Phase 1, will be a multi-center, open-label, randomized, placebo-controlled study of the recommended AUP1602-C dose and administration schedule from Phase 1 to confirm safety and to assess efficacy of the selected recommended phase 2 dose and schedule in DFU patients.
Study:
NCT04281992
Study Brief:
Protocol Section:
NCT04281992