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NCT06767501 · ClinicalTrials.gov registry record · NA

Clinical Trial Evaluating an Amnion Membrane Allograft for Use in the Management of Non- Healing Diabetic Foot Ulcers Versus Standard Of Care

A NA study of Diabetic Foot Ulcers (DFUs), sponsored by Skye Biologics Holdings.

Recruiting
Registry status
NA
Development phase
100
Enrollment target
1
Study location

NCT06767501 is a NA study of Diabetic Foot Ulcers (DFUs) that is actively recruiting participants, run by Skye Biologics Holdings. The registered enrollment target is 100 participants. The trial reports 1 study location across 1 state.

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The verdict

NCT06767501, a NA study of Diabetic Foot Ulcers (DFUs), is actively recruiting participants, sponsored by Skye Biologics Holdings.

RECRUITING
Registry status
NA
Development phase
100 participants
Enrollment target
1
Study location

Study Summary

The main purpose of this research study is to compare the proportion of wound closure in subjects that receive E-GRAFT™ with Standard of Care (SOC) versus FIBRACOL™ with SOC. Other research purposes include the following: * Rate of wound closure * Change in ulcer size over 12 weeks * Any adverse events or reactions (side effects) * Changes in neuropathy (nerve damage) * Change in pain levels * Occurrence of infection

Interventions

  • OTHER E-GRAFT ™
  • DEVICE FIBRACOL™

Study Locations (1)

Virginia

  • Professional Education and Research Institute - Roanoke

Trial Details

FieldValue
Enrollment Target 100 participants
Start Date 2024-12-28
Est. Completion 2025-12
Phase NA

Sponsor

Skye Biologics Holdings

3 total trials

What the Registry Record Tells You About NCT06767501

The ClinicalTrials.gov registry entry for NCT06767501 describes a study currently listed as recruiting, categorized as NA. The registered enrollment target is 100 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Skye Biologics Holdings, which has 3 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Diabetic Foot Ulcers (DFUs) appearing as the primary indexed condition, and to 2 interventions - of which E-GRAFT ™ is the first listed.

NCT06767501 reports 1 study location spanning 1 distinct geographic area - top geographies include Virginia.

Frequently Asked Questions

What is clinical trial NCT06767501 about?

NCT06767501 is a clinical study titled "Clinical Trial Evaluating an Amnion Membrane Allograft for Use in the Management of Non- Healing Diabetic Foot Ulcers Versus Standard Of Care". The main purpose of this research study is to compare the proportion of wound closure in subjects that receive E-GRAFT™ with Standard of Care (SOC) versus FIBRACOL™ with SOC. Other research purposes include the following: * Rate of wound closure * Change in ulcer size over 12 weeks * Any adverse ev...

What is the current status of trial NCT06767501?

This trial is currently recruiting. It is a NA study. The enrollment target is 100 participants. The study started on 2024-12-28. Estimated completion is 2025-12.

What conditions does trial NCT06767501 study?

This clinical trial studies the following conditions: Diabetic Foot Ulcers (DFUs).

What interventions are being tested in trial NCT06767501?

The interventions under investigation include: E-GRAFT ™ (OTHER), FIBRACOL™ (DEVICE).

Who is sponsoring clinical trial NCT06767501?

This trial is sponsored by Skye Biologics Holdings, which has 3 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT06767501 being conducted?

This trial has 1 study location across Virginia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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

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