Status:
COMPLETED
Comparative Effectiveness of Two Acellular Matrices (Dermacell vs. Integra) for Management of Deep Diabetic Foot Ulcers
Lead Sponsor:
Baylor College of Medicine
Collaborating Sponsors:
LifeNet Health
Conditions:
Diabetic Foot Ulcer
Deep Diabetic Foot Ulcer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
PHASE3
Brief 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...
Eligibility Criteria
Inclusion
- 18 years or older
- Non-infected deep wounds (Grade 2 Wagner Ulcer Classification)
Exclusion
- Minors
- Wounds with bone exposure
- Active infection
- Gangrene or osteomyelitis
- Major vascular problems (ABI \<0.5 or \>1.3)
- Unable to comply with follow up visits (e.g. long distance travel)
- Unable or unwilling to provide consent
Key Trial Info
Start Date :
April 2 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 2 2021
Estimated Enrollment :
34 Patients enrolled
Trial Details
Trial ID
NCT03476876
Start Date
April 2 2018
End Date
April 2 2021
Last Update
July 7 2023
Active Locations (1)
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1
Baylor College of Medicine
Houston, Texas, United States, 77030