Clinical Utility of an Amniotic Membrane Allograft for Diabetic Foot Ulcer

Status Not yet recruiting

Clinical Trial Summary

The goal of this clinical trial is to learn if use of Orion TM, a dual-layer amniotic membrane allograft, in addition to standard wound care treatment can improve patient outcomes for people over the age of 50 with diabetic foot ulcers. The main question it aims to answer is the incidence of complete wound closure at the end of 12 weeks of treatment. Researchers will compare the outcomes between a group of people treated with standard wound care and another group treated with standard wound care in addition to the amniotic membrane allograft to see if the amniotic membrane allograft improves patient outcomes. Participants will visit their doctor weekly over a 12 week period, as per standard diabetic foot ulcer treatment procedures, and fill out a questionnaire measuring quality of life.

Clinical Trial Description

Lower extremity diabetic ulcers are a common complication affecting millions of people in the United States. The purpose of this study is to evaluate the clinical utility of Orion TM, a dual-layer amniotic membrane allograft, versus standard wound care in the management of diabetic foot ulcers. Amniotic membrane allografts are confirmed by the FDA Tissue Reference Group to meet the criteria for regulation solely under Section 361 of the PHS Act as defined in 21 CFR Part 1271 for the management of diabetic foot ulcers. Investigators hypothesize that the group of participants who receive amniotic membrane allografts in addition to standard wound care will experience a faster rate and higher incidence of complete wound closure compared to standard wound care alone. For only partially healed wounds, investigators anticipate a statistically significant reduction in the size of the ulcer and improved quality of life for participants in the experimental arm compared to standard wound care alone. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT06420245
Study type	Interventional
Source	Legacy Medical Consultants
Contact	Jennifer Linksy
Phone	813-600-9290
Email	jennifer@legacymedicalconsultants.com
Status	Not yet recruiting
Phase	N/A
Start date	June 2024
Completion date	July 2025

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See also
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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

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.

Clinical Utility of an Amniotic Membrane Allograft for Diabetic Foot Ulcer Wound Management — REBOUND

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms