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NCT06557122 · ClinicalTrials.gov registry record · NA
Clinical Study to Compare Two Skin Substitute Categories for Their Effectiveness to Treat Diabetic Foot Ulcers
A NA study of Diabetic Foot Ulcer, sponsored by Encoll.
- Completed
- Registry status
- NA
- Development phase
- 24
- Enrollment target
- 3
- Study locations
NCT06557122: Completed NA study of Diabetic Foot Ulcer, sponsored by Encoll.
NCT06557122 is a NA study of Diabetic Foot Ulcer that has completed, run by Encoll. The registered enrollment target is 24 participants, below the 255-participant average among 67 other Diabetic Foot Ulcer trials with a reported enrollment target (91% lower). The trial reports 3 study locations across 3 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06557122, a NA study of Diabetic Foot Ulcer, has completed, sponsored by Encoll.
- COMPLETED
- Registry status
- NA
- Development phase
- 24 participants
- Enrollment target
- 3
- Study locations
Study Summary
The purpose of this clinical evaluation is to collect patient outcome data on a commercially available 510K FDA cleared advanced skin substitute. The commercially available product is Helicoll® Advanced Skin Substitute. In this trial two groups of subjects with Wagner 1 diabetic foot ulcers (DFUs), will receive standard of care (SOC) treatment for their condition. Half of the patients will have their SOC treatment with Epifix® or Grafix® and the other half will receive a 510K FDA cleared Helicoll® Advanced Skin Substitute as the primary treatment. The primary endpoint is the percentage wound area reduction of the target ulcer. Secondary endpoints include the proportion of subjects that obtain complete closure over the 5-week treatment period, the time to achieve complete wound closure of the target ulcer by the end of 5 weeks, and mean number of IP applications.
Primary Outcome
Average Percentage of Wound Area Reduction from Treatment Visit 1 to Treatment Visit 4 measured manually with digital photography
Conditions Studied
Interventions
- DEVICE SOC and Advanced Bioengineered Skin Substitute
- OTHER SOC and Active Comparator
Study Locations (3)
California
- Clemente Clinical Research - Los Angeles
Florida
- Doctors Research Network - South Miami
Virginia
- Foot and Ankle Specialists of the Mid-Atlantic - Salem
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 24 participants |
| Start Date | 2024-07-25 |
| Est. Completion | 2024-10-25 |
| Phase | NA |
What the finished NCT06557122 record still lists
NCT06557122 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 24 participants, a relatively small participant target, below the 255-participant average among 67 other Diabetic Foot Ulcer trials with a reported enrollment target (91% lower).
The record links to 1 condition, with Diabetic Foot Ulcer appearing as the primary indexed condition, and to 2 interventions - of which SOC and Advanced Bioengineered Skin Substitute is the first listed.
NCT06557122 reports a single indexed study location in California, Florida, Virginia.
Frequently Asked Questions
What is clinical trial NCT06557122 about?
NCT06557122 is a clinical study titled "Clinical Study to Compare Two Skin Substitute Categories for Their Effectiveness to Treat Diabetic Foot Ulcers". The purpose of this clinical evaluation is to collect patient outcome data on a commercially available 510K FDA cleared advanced skin substitute. The commercially available product is Helicoll® Advanced Skin Substitute. In this trial two groups of subjects with Wagner 1 diabetic foot ulcers (DFUs),...
What is the current status of trial NCT06557122?
This trial is currently completed. It is a NA study. The enrollment target is 24 participants. The study started on 2024-07-25. Estimated completion is 2024-10-25.
What conditions does trial NCT06557122 study?
This clinical trial studies the following conditions: Diabetic Foot Ulcer.
What interventions are being tested in trial NCT06557122?
The interventions under investigation include: SOC and Advanced Bioengineered Skin Substitute (DEVICE), SOC and Active Comparator (OTHER).
Who is sponsoring clinical trial NCT06557122?
This trial is sponsored by Encoll, which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06557122 being conducted?
This trial has 3 study locations across California, Florida, Virginia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Diabetic Foot Ulcer
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 NCT06557122's enrollment target sits among peer trials
24 60th of 67 higher than 8 of 67 other Diabetic Foot Ulcer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Diabetic Foot Ulcer 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
-
Feasibility and Effectiveness of a Remote Monitoring Program for the Treatment of Diabetic Foot Ulcers
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-
Study Assessing Complete Wound Healing by Comparing Surgenex® PelloGraft in Treating DFU and SanoGraft® in Treating VLU to SOC
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A Clinical Investigation to Follow the Progress of Exuding Chronic Wounds Using Mepilex® Up as the Primary Dressing.
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Modified Platform Trial Evaluating PpLHACM and SOC Versus SOC Alone in the Treatment of Nonhealing DFUs
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Derm-Maxx in Patients With Diabetic Foot Ulcers Unresponsive to Standard of Care Treatment Alone
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-
Exercise Enhances Wound Healing in Patients With Diabetic Foot Ulcers
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