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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: Recruiting NA study of Diabetic Foot and Diabetic Foot Ulcer (DFU), sponsored by StimLabs.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Determine the percent of target ulcers achieving complete wound closure at 12 weeks. In addition, a qualified third-party clinician will independently confirm wound closure.
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 |
What NCT06449638 shows while recruiting
NCT06449638 is an interventional study that assigns participants to a tested intervention. The registered 272 participants enrollment target is mid-sized for trials with a published cap, below the 10,332-participant average among 30 other Diabetic Foot trials with a reported enrollment target (97% lower).
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 lists 5 locations in 3 states (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.
Learn More About Clinical Trials
Similar trials for Diabetic Foot
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 NCT06449638's enrollment target sits among peer trials
272 9th of 30 higher than 22 of 30 other Diabetic Foot trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Diabetic Foot 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
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Feasibility and Effectiveness of a Remote Monitoring Program for the Treatment of Diabetic Foot Ulcers
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-
Effectiveness of Remote Foot Temperature Monitoring
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-
Modified Platform Trial Evaluating PpLHACM and SOC Versus SOC Alone in the Treatment of Nonhealing DFUs
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Evaluating the Efficacy of a Single Layer Placental-based Allograft and Standard of Care Versus Standard of Care
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-
Dehydrated Human Amnion Membrane and Standard of Care Versus Standard of Care Alone in Nonhealing Diabetic Foot Ulcers
RECRUITING · NA
-
Adapting Lifestyle Offloading for DFUs
RECRUITING · NA
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