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Modified Platform Trial Assessing Multiple CAMPs and SOC vs SOC Alone in the Treatment of Hard-to-Heal DFUs
NCT06449638 · View on ClinicalTrials.gov ↗
Study Summary
The purpose of this study is to evaluate the efficacy of four dehydrated complete human placental membrane, also defined as Cellular, Acellular, Matrix-like Products/skin substitutes, plus SOC versus SOC alone in achieving complete closure of hard-to-heal diabetic foot ulcers over 12 weeks using a modified platform trial design.
Conditions Studied
Interventions
- OTHER Standard of Care
- OTHER Revita
- OTHER Relese
- OTHER Cogenex
- OTHER Enverse
Study Locations (5)
Pennsylvania
- SerenaGroup Research South — Jefferson Hills
- Armstrong County Memorial Hospital — Kittanning
- SerenaGroup Monroeville — Monroeville
Nebraska
- SerenaGroup Omaha Research Center — Omaha
Oklahoma
- Wound Care of Tulsa — Tulsa
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 272 participants |
| Start Date | 2024-07-16 |
| Est. Completion | 2026-12 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06449638
The ClinicalTrials.gov registry entry for NCT06449638 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 272 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is StimLabs, 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 4 conditions, with Diabetic Foot appearing as the primary indexed condition, and to 5 interventions — of which Standard of Care 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: NCT06449638 reports 5 study locations spanning 3 distinct geographic areas — top geographies include Pennsylvania, Nebraska, Oklahoma. 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 NCT06449638 about?
NCT06449638 is a clinical study titled "Modified Platform Trial Assessing Multiple CAMPs and SOC vs SOC Alone in the Treatment of Hard-to-Heal DFUs". The purpose of this study is to evaluate the efficacy of four dehydrated complete human placental membrane, also defined as Cellular, Acellular, Matrix-like Products/skin substitutes, plus SOC versus SOC alone in achieving complete closure of hard-to-heal diabetic foot ulcers over 12 weeks using a m...
What is the current status of trial NCT06449638?
This trial is currently recruiting. It is a NA study. The enrollment target is 272 participants. The study started on 2024-07-16. Estimated completion is 2026-12.
What conditions does trial NCT06449638 study?
This clinical trial studies the following conditions: Diabetic Foot, Diabetic Foot Ulcer (DFU), Foot Ulcer, Ulcer Foot. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT06449638?
The interventions under investigation include: Standard of Care (OTHER), Revita (OTHER), Relese (OTHER), Cogenex (OTHER), Enverse (OTHER). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT06449638?
This trial is sponsored by StimLabs, 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 NCT06449638 being conducted?
This trial has 5 study locations across Nebraska, Oklahoma, Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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