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NCT03476876 · ClinicalTrials.gov registry record · Phase 2
Comparative Effectiveness of Two Acellular Matrices (Dermacell vs. Integra) for Management of Deep Diabetic Foot Ulcers
A Phase 2 study of Diabetic Foot Ulcer and Deep Diabetic Foot Ulcer, sponsored by Baylor College of Medicine.
- Completed
- Registry status
- Phase 2
- Development phase
- 34
- Enrollment target
- 1
- Study location
NCT03476876 is a Phase 2 study of Diabetic Foot Ulcer and Deep Diabetic Foot Ulcer that has completed, run by Baylor College of Medicine. The registered enrollment target is 34 participants, below the 254-participant average among 67 other Diabetic Foot Ulcer trials with a reported enrollment target (87% lower). The trial reports 1 study location across 1 state.
The verdict
NCT03476876, a Phase 2 study of Diabetic Foot Ulcer and Deep Diabetic Foot Ulcer, has completed, sponsored by Baylor College of Medicine.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 34 participants
- Enrollment target
- 1
- Study location
Study Summary
Diabetes-related foot ulcers (DFUs) are a leading cause of hospitalization and amputation worldwide, and account for 33% of all direct costs of diabetes care in the US. Ulcers requiring acute care can result in treatment costs of up to US$70,000 per event, varying with the severity of the wound. Once the skin is ulcerated, it is susceptible to becoming infected and ultimately amputation in particular in case of deep DFUs. To manage the cost and avoid hospitalization and amputation, wound should be immediately closed. But this is often challenging in diabetic foot with deep ulcers.Wound healing is a dynamic process involving interactions between cells, extracellular matrix (ECM) and growth factors that reconstitutes tissue following injury. ECM plays an important role in tissue regeneration and is the major component of the dermal skin layer. Recognition of the importance of the ECM in wound healing has led to the development of wound products that aim to stimulate or replace the ECM in particular in case of deep tissue destruction because of deep DFUs. It is known from the literature that chronic or hard-to-heal wounds are characterized by a disrupted or damaged ECM that cannot support wound healing. Thus treatment strategies based on use of biologic scaffold materials for management of chronic and deep wounds has increased dramatically during the past two decades. These scaffolds include those comprising an intact extracellular matrix (ECM) or individual components of the ECM, and those comprising hybrids incorporating a synthetic component with a biologic component. DermACELL (LifeNet Health,Virginia Beach, VA) is acellular dermal matrices (ADM), which has been shown to be effective in treating chronic DFUs in a clinical trial. Another ADM product available in the market is made by Integra® (Bilayer Matrix Wound Dressing, Integra LifeSciences). However, advantages/disadvantages of one compared to the other are unclear. In addition, prior studies often focused on
Conditions Studied
Interventions
- COMBINATION_PRODUCT Dermacell
- COMBINATION_PRODUCT Integra
Study Locations (1)
Texas
- Baylor College of Medicine - Houston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 34 participants |
| Start Date | 2018-04-02 |
| Est. Completion | 2021-04-02 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03476876
The ClinicalTrials.gov registry entry for NCT03476876 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 34 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 254-participant average among 67 other Diabetic Foot Ulcer trials with a reported enrollment target (87% lower). The listed sponsor is Baylor College of Medicine, which has 616 total studies on file at ClinicalTrials.gov.
The record links to 2 conditions, with Diabetic Foot Ulcer appearing as the primary indexed condition, and to 2 interventions - of which Dermacell is the first listed.
NCT03476876 reports 1 study location spanning 1 distinct geographic area - top geographies include Texas.
Frequently Asked Questions
What is clinical trial NCT03476876 about?
NCT03476876 is a clinical study titled "Comparative Effectiveness of Two Acellular Matrices (Dermacell vs. Integra) for Management of Deep Diabetic Foot Ulcers". Diabetes-related foot ulcers (DFUs) are a leading cause of hospitalization and amputation worldwide, and account for 33% of all direct costs of diabetes care in the US. Ulcers requiring acute care can result in treatment costs of up to US$70,000 per event, varying with the severity of the wound. Onc...
What is the current status of trial NCT03476876?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 34 participants. The study started on 2018-04-02. Estimated completion is 2021-04-02.
What conditions does trial NCT03476876 study?
This clinical trial studies the following conditions: Diabetic Foot Ulcer, Deep Diabetic Foot Ulcer.
What interventions are being tested in trial NCT03476876?
The interventions under investigation include: Dermacell (COMBINATION_PRODUCT), Integra (COMBINATION_PRODUCT).
Who is sponsoring clinical trial NCT03476876?
This trial is sponsored by Baylor College of Medicine, which has 616 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03476876 being conducted?
This trial has 1 study location across Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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