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NCT06420245 · ClinicalTrials.gov registry record · NA
Clinical Utility of an Amniotic Membrane Allograft for Diabetic Foot Ulcer Wound Management
A NA study of Diabetic Foot Ulcer, sponsored by Legacy Medical Consultants.
- Recruiting
- Registry status
- NA
- Development phase
- 240
- Enrollment target
- 2
- Study locations
NCT06420245 is a NA study of Diabetic Foot Ulcer that is actively recruiting participants, run by Legacy Medical Consultants. The registered enrollment target is 240 participants, roughly in line with the 251-participant average among 67 other Diabetic Foot Ulcer trials with a reported enrollment target. The trial reports 2 study locations across 1 state.
The verdict
NCT06420245, a NA study of Diabetic Foot Ulcer, is actively recruiting participants, sponsored by Legacy Medical Consultants.
- RECRUITING
- Registry status
- NA
- Development phase
- 240 participants
- Enrollment target
- 2
- Study locations
Study Summary
The goal of this clinical trial is to learn if use of Orion™, 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 study aims to determine 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 wound healing. During the study, participants will visit their doctor weekly over a 12 week period, which is standard for diabetic foot ulcer treatment procedures, and fill out a questionnaire measuring quality of life.
Conditions Studied
Interventions
- PROCEDURE Standard of Care (SOC)
- DEVICE Orion TM Amniotic Membrane Allograft
Study Locations (2)
California
- Center for Clinical Research Inc. - San Francisco
- ILD Research Center - Vista
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 240 participants |
| Start Date | 2025-12-30 |
| Est. Completion | 2027-07 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06420245
The ClinicalTrials.gov registry entry for NCT06420245 describes a study currently listed as recruiting, categorized as NA. The registered enrollment target is 240 participants, a figure that helps gauge the scale of data the investigators plan to collect, roughly in line with the 251-participant average among 67 other Diabetic Foot Ulcer trials with a reported enrollment target. The listed sponsor is Legacy Medical Consultants, which has 2 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Diabetic Foot Ulcer appearing as the primary indexed condition, and to 2 interventions - of which Standard of Care (SOC) is the first listed.
NCT06420245 reports 2 study locations spanning 1 distinct geographic area - top geographies include California.
Frequently Asked Questions
What is clinical trial NCT06420245 about?
NCT06420245 is a clinical study titled "Clinical Utility of an Amniotic Membrane Allograft for Diabetic Foot Ulcer Wound Management". The goal of this clinical trial is to learn if use of Orion™, 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 study aims to determine the incidence of complete wound closu...
What is the current status of trial NCT06420245?
This trial is currently recruiting. It is a NA study. The enrollment target is 240 participants. The study started on 2025-12-30. Estimated completion is 2027-07.
What conditions does trial NCT06420245 study?
This clinical trial studies the following conditions: Diabetic Foot Ulcer.
What interventions are being tested in trial NCT06420245?
The interventions under investigation include: Standard of Care (SOC) (PROCEDURE), Orion TM Amniotic Membrane Allograft (DEVICE).
Who is sponsoring clinical trial NCT06420245?
This trial is sponsored by Legacy Medical Consultants, which has 2 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06420245 being conducted?
This trial has 2 study locations across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Read our methodology - how this data is sourced, computed, and verified.
Related
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