NCT03232333

MIRODERM H2H DFU Study

Effectiveness of MIRODERM® Biologic Wound Matrix in the Treatment of Hard-to-Heal Diabetic Foot Ulcers

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 53 (actual)
• Sponsor: Miromatrix Medical Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: —

Summary

This study will assess the ability of MIRODERM to heal difficult diabetic foot ulcers within 12 weeks of treatment.

Detailed description

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

Conditions

• Diabetic Foot Ulcer

Interventions

Type	Name	Description
DEVICE	Biologic wound graft	Diabetic foot ulcer will be treated by grafting with MIRODERM Biologic Wound Matrix

Timeline

• Start date: 2017-07-21
• Primary completion: 2018-09-20
• Completion: 2018-09-20
• First posted: 2017-07-28
• Last updated: 2019-10-22
• Results posted: 2019-10-09

Locations

9 sites across 1 country: United States

Regulatory

• FDA-regulated device study