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NCT07116174 · ClinicalTrials.gov registry record · NA
A Prospective Clinical Study to Evaluate the Effectiveness and Safety of Xcell Amnio MatrixTM (XAM) in the Management of Chronic Non-healing DFUs
A NA study of Diabetic Foot Ulcer (DFU), sponsored by New Horizon Medical Solutions.
- Recruiting
- Registry status
- NA
- Development phase
- 135
- Enrollment target
- 1
- Study location
NCT07116174 is a NA study of Diabetic Foot Ulcer (DFU) that is actively recruiting participants, run by New Horizon Medical Solutions. The registered enrollment target is 135 participants, below the 508-participant average among 13 other Diabetic Foot Ulcer (DFU) trials with a reported enrollment target (73% lower). The trial reports 1 study location across 1 state.
The verdict
NCT07116174, a NA study of Diabetic Foot Ulcer (DFU), is actively recruiting participants, sponsored by New Horizon Medical Solutions.
- RECRUITING
- Registry status
- NA
- Development phase
- 135 participants
- Enrollment target
- 1
- Study location
Study Summary
The goal of this clinical trial is to evaluate the clinical outcomes of Diabetic Foot Ulcers (DFUs) treated with a weekly application of Xcell Amnio MatrixTM (XAM) as adjunct to standard of care (SOC) compared to SOC alone in male and female over the age of 18 years old. The main question it aims to answer is: What is the proportion of subjects with complete wound closure during the 12 weeks of the treatment phase? Participants: * Will be screened and re-screened after 2 weeks to be assessed whether they meet the eligibility criteria * Eligible subjects will receive study product application, and for 12 weeks will return to the clinic once every 7 days (±3 days) for treatment visits * Subjects who complete the treatment will be followed up after 2 weeks
Conditions Studied
Interventions
- DRUG Standard of Care (SOC)
- BIOLOGICAL Xcell Amnio Matrix
Study Locations (1)
Texas
- Richard C. Galperin - Dallas
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 135 participants |
| Start Date | 2025-08-15 |
| Est. Completion | 2026-08-15 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT07116174
The ClinicalTrials.gov registry entry for NCT07116174 describes a study currently listed as recruiting, categorized as NA. The registered enrollment target is 135 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 508-participant average among 13 other Diabetic Foot Ulcer (DFU) trials with a reported enrollment target (73% lower). The listed sponsor is New Horizon Medical Solutions, which has 1 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Diabetic Foot Ulcer (DFU) appearing as the primary indexed condition, and to 2 interventions - of which Standard of Care (SOC) is the first listed.
NCT07116174 reports 1 study location spanning 1 distinct geographic area - top geographies include Texas.
Frequently Asked Questions
What is clinical trial NCT07116174 about?
NCT07116174 is a clinical study titled "A Prospective Clinical Study to Evaluate the Effectiveness and Safety of Xcell Amnio MatrixTM (XAM) in the Management of Chronic Non-healing DFUs". The goal of this clinical trial is to evaluate the clinical outcomes of Diabetic Foot Ulcers (DFUs) treated with a weekly application of Xcell Amnio MatrixTM (XAM) as adjunct to standard of care (SOC) compared to SOC alone in male and female over the age of 18 years old. The main question it aims to...
What is the current status of trial NCT07116174?
This trial is currently recruiting. It is a NA study. The enrollment target is 135 participants. The study started on 2025-08-15. Estimated completion is 2026-08-15.
What conditions does trial NCT07116174 study?
This clinical trial studies the following conditions: Diabetic Foot Ulcer (DFU).
What interventions are being tested in trial NCT07116174?
The interventions under investigation include: Standard of Care (SOC) (DRUG), Xcell Amnio Matrix (BIOLOGICAL).
Who is sponsoring clinical trial NCT07116174?
This trial is sponsored by New Horizon Medical Solutions, which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT07116174 being conducted?
This trial has 1 study location across Texas. 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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