Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.

RECRUITING NA

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

NCT06420245 · View on ClinicalTrials.gov ↗

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

FieldValue
Enrollment Target 240 participants
Start Date 2025-12-30
Est. Completion 2027-07
Phase NA

Sponsor

Legacy Medical Consultants

2 total trials

Interested in This Trial?

Always speak with your doctor before enrolling in a clinical trial.

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. It is categorized as NA, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 240 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Legacy Medical Consultants, which has 2 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT06420245 reports 2 study locations spanning 1 distinct geographic area — top geographies include California. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT06420245?

The interventions under investigation include: Standard of Care (SOC) (PROCEDURE), Orion TM Amniotic Membrane Allograft (DEVICE). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT06420245?

This trial is sponsored by Legacy Medical Consultants, which has 2 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial