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Rising Tide - Amniotic Tissue(s) Treatments for Chronic Diabetic Foot Ulcers
NCT06681428 · View on ClinicalTrials.gov ↗
Study Summary
The purpose of this clinical investigation is to evaluate the safety and efficacy of Amnion/Chorion/Amnion allograft , Amnion/Chorion allograft, and/or Amnion/Amnion allograft, plus Standard of Care (SOC) each versus SOC alone in the treatment of chronic non-healing diabetic foot ulcers (DFU) after 12 weeks of treatment.
Conditions Studied
Interventions
- OTHER Allograft
Study Locations (9)
California
- Limb Preservation Platform Inc — Fresno
- Angel City Research — Los Angeles
- Clemente Clinical Research — Los Angeles
- ILD Research Center — Vista
Ohio
- Lower Extremity Institute of Research and Therapy — Boardman
- Brock Liden DPM — Circleville
Florida
- Clever Medical Research — Miami
North Carolina
- Foot and Ankle Specialists of the Mid-Atlantic — Raleigh
Virginia
- Foot and Ankle Specialists of the Mid-Atlantic — Salem
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 240 participants |
| Start Date | 2024-11-14 |
| Est. Completion | 2026-11-18 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06681428
The ClinicalTrials.gov registry entry for NCT06681428 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 Tides Medical, 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 2 conditions, with Diabetic Foot Ulcer (DFU) appearing as the primary indexed condition, and to 1 intervention — of which Allograft 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: NCT06681428 reports 9 study locations spanning 5 distinct geographic areas — top geographies include California, Ohio, Florida. 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 NCT06681428 about?
NCT06681428 is a clinical study titled "Rising Tide - Amniotic Tissue(s) Treatments for Chronic Diabetic Foot Ulcers". The purpose of this clinical investigation is to evaluate the safety and efficacy of Amnion/Chorion/Amnion allograft , Amnion/Chorion allograft, and/or Amnion/Amnion allograft, plus Standard of Care (SOC) each versus SOC alone in the treatment of chronic non-healing diabetic foot ulcers (DFU) after ...
What is the current status of trial NCT06681428?
This trial is currently recruiting. It is a NA study. The enrollment target is 240 participants. The study started on 2024-11-14. Estimated completion is 2026-11-18.
What conditions does trial NCT06681428 study?
This clinical trial studies the following conditions: Diabetic Foot Ulcer (DFU), Chronic Foot Ulcers. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT06681428?
The interventions under investigation include: Allograft (OTHER). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT06681428?
This trial is sponsored by Tides Medical, 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 NCT06681428 being conducted?
This trial has 9 study locations across California, Florida, North Carolina, Ohio, Virginia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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