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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: Recruiting NA study of Diabetic Foot Ulcer, sponsored by Legacy Medical Consultants.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Percentage of enrolled study participants demonstrating 100% re-epithelialization of the index wound without leaking exudate at 12 weeks post-randomization.
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 |
What NCT06420245 shows while recruiting
NCT06420245 is an interventional study that assigns participants to a tested intervention. The registered 240 participants enrollment target is mid-sized for trials with a published cap, roughly in line with the 251-participant average among 67 other Diabetic Foot Ulcer trials with a reported enrollment target.
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 a single indexed study location in 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
Similar trials for Diabetic Foot Ulcer
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT06420245's enrollment target sits among peer trials
240 14th of 67 higher than 54 of 67 other Diabetic Foot Ulcer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Diabetic Foot Ulcer trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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Feasibility and Effectiveness of a Remote Monitoring Program for the Treatment of Diabetic Foot Ulcers
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-
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-
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