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:
2025-12-25 @ 3:47 AM
Ignite Modification Date:
2025-12-25 @ 3:47 AM
NCT ID:
NCT07089602
Brief Summary:
The purpose of this study is to evaluate the efficacy of human placental membrane products and standard of care versus standard of care alone in the management of nonhealing diabetic foot ulcers and venous leg ulcers.
Detailed Description:
This study is a multi-center, prospective, randomized controlled clinical study consisting of 650 subjects from up to 30 centers. The subjects are randomized to receive 1 of 4 treatments, either with Tri-Membrane Wrap™ (HPM-1); Membrane Wrap™ (HPM-2); Membrane Wrap-Lite™ (HPM-3); Membrane Wrap-Hydro™ (HPM-4); and SOC. The target ulcers are evaluated weekly by the investigator. The subject is treated once a week, to receive weekly applications of HPM-1 - HPM - 4 + SOC or SOC alone until or up to 12 weeks or until the study ulcer has completely closed (i.e. 100% closure as assessed by the investigator and confirmed 2 weeks later at the closure confirmation visit (CCV). One additional visit per week is optional for both arms, for the purpose of changing only (1) the secondary dressing in the HPM arm or (2) change the standard of care dressing in the control arm. A trial design diagram is found in Figure 3.
Study:
NCT07089602
Study Brief:
Protocol Section:
NCT07089602