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NCT06449638 · ClinicalTrials.gov registry record · NA
Modified Platform Trial Assessing Multiple CAMPs and SOC vs SOC Alone in the Treatment of Hard-to-Heal DFUs
A NA study of Diabetic Foot and Diabetic Foot Ulcer (DFU), sponsored by StimLabs.
- Recruiting
- Registry status
- NA
- Development phase
- 272
- Enrollment target
- 5
- Study locations
NCT06449638 is a NA study of Diabetic Foot and Diabetic Foot Ulcer (DFU) that is actively recruiting participants, run by StimLabs. The registered enrollment target is 272 participants, below the 10,332-participant average among 30 other Diabetic Foot trials with a reported enrollment target (97% lower). The trial reports 5 study locations across 3 states.
The verdict
NCT06449638, a NA study of Diabetic Foot and Diabetic Foot Ulcer (DFU), is actively recruiting participants, sponsored by StimLabs.
- RECRUITING
- Registry status
- NA
- Development phase
- 272 participants
- Enrollment target
- 5
- Study locations
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 |
Interested in This Trial?
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, categorized as NA. The registered enrollment target is 272 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 10,332-participant average among 30 other Diabetic Foot trials with a reported enrollment target (97% lower). The listed sponsor is StimLabs, which has 5 total studies on file at ClinicalTrials.gov.
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.
NCT06449638 reports 5 study locations spanning 3 distinct geographic areas - top geographies include Pennsylvania, Nebraska, Oklahoma.
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.
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).
Who is sponsoring clinical trial NCT06449638?
This trial is sponsored by StimLabs, which has 5 total clinical trials registered on ClinicalTrials.gov.
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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Related
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