Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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: Recruiting NA study of Diabetic Foot Ulcer (DFU), sponsored by New Horizon Medical Solutions.
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. According to ClinicalTrials.gov, the official US trial registry.
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
Primary Outcome
Complete wound closure is defined as 100% re-epithelialization without drainage or dressing requirements confirmed at two consecutive study visits 2 weeks apart.
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 |
What NCT07116174 shows while recruiting
NCT07116174 is an interventional study that assigns participants to a tested intervention. The registered 135 participants enrollment target is mid-sized for trials with a published cap, below the 508-participant average among 13 other Diabetic Foot Ulcer (DFU) trials with a reported enrollment target (73% lower).
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 a single indexed study location in 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
Similar trials for Diabetic Foot Ulcer (DFU)
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 NCT07116174's enrollment target sits among peer trials
135 10th of 13 higher than 4 of 13 other Diabetic Foot Ulcer (DFU) trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Diabetic Foot Ulcer (DFU) 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
-
Rising Tide - Amniotic Tissue(s) Treatments for Chronic Diabetic Foot Ulcers
RECRUITING · NA
-
CARE-D-FOOT-Nav Pilot
RECRUITING · NA
-
CAMP RWE Trial: Amnion Grafts for Healing Hard-to-Heal Ulcers in RW Populations
RECRUITING · NA
-
Modified Platform Trial Assessing Multiple CAMPs and SOC vs SOC Alone in the Treatment of Hard-to-Heal DFUs
RECRUITING · NA
-
Matrion Decellularized Placental Membrane Versus Conventional Wound Management in Subjects With Diabetic Foot Ulcers
RECRUITING · NA
-
Remote Temperature and Visual Monitoring To Help Manage Diabetic Foot Ulcers
ACTIVE NOT RECRUITING · NA
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT00870129 · 135 participants · NA
Magnetic Resonance (MR) Imaging to Determine High Risk Areas in Patients With Malignant Gliomas and to Design Potential Radiation Plans and to Examine Metabolite Changes in Gliomas and Other Solid Tumors
- NCT03666000 · 135 participants · Phase 1
Dose-escalation and Dose-expansion Study of Safety of Azer-cel (PBCAR0191) in Participants With Relapsed/Refractory (r/r) Non-Hodgkin Lymphoma (NHL) and r/r B-cell Acute Lymphoblastic Leukemia (B-ALL)
- NCT04891510 · 135 participants · NA
A Comparative Analysis of REVOLVE, LipoGrafter, and Viality in Autologous Fat Grafting During Breast Surgery
- NCT05121051 · 135 participants · Phase 2
Testing the Effect of the Broccoli Seed and Sprout Extract, Avmacol ES, on the Cancer Causing Substances of Tobacco in Heavy Smokers
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI