Diabetic Foot Ulcer Clinical Trial
Official title:
Effectiveness of MIRODERM® Biologic Wound Matrix in the Treatment of Hard-to-Heal Diabetic Foot Ulcers
This study will assess the ability of MIRODERM to heal difficult diabetic foot ulcers within 12 weeks of treatment.
The primary objective of this study is to determine the number of successful complete wound
closures within 12 weeks of treatment with MIRODERM Fenestrated Biological Wound Matrix. Some
secondary objectives of this study include documenting the time course of wound healing and
assessing changes in quality of life.
The primary cohort is individuals suffering from a diabetic foot ulcer that has not been
healed in the last 3 months and after at least 2 attempts with an advanced biologic. Ulcer
will be between 1 and 12 cm squared, less than 5 mm deep, full thickness, below the ankle,
and with no exposed bone or tendon. Subjects will be 18 or older, have Type I or II diabetes
with adequate vascular profusion. Subjects will be unable to participate if they have
osteomyelitis, Charcot foot, a known collagen vascular disease, are on dialyses, are
immunocompromised or have an HbA1c level equal to or great than 12%.
This is a single-arm study with no Independent Variables. Descriptive data to be collected
will include demographics, pathology and medical history.
Outcome assessments:
- proportion of subjects with 100% epithelialization of wound
- SF-36
- Adverse events
;
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