Ignite Creation Date:
2025-12-25 @ 2:53 AM
Ignite Modification Date:
2026-01-07 @ 3:34 PM
Study NCT ID:
NCT03232333
Status:
COMPLETED
Last Update Posted:
2019-10-22
First Post:
2017-07-25
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
MIRODERM H2H DFU Study
Sponsor:
Miromatrix Medical Inc.
Organization:
Study Overview
Official Title:
Effectiveness of MIRODERM® Biologic Wound Matrix in the Treatment of Hard-to-Heal Diabetic Foot Ulcers
Status:
COMPLETED
Status Verified Date:
2019-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
H2H-DFU
Brief 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
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
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: