MIRODERM H2H DFU Study

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

53 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-07-21

Study Completion Date

2018-09-20

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

miR-200b & miR-21 in Diabetic Wounds

NCT02581098

Diabetes Mellitus Foot Ulcer Ulcer +3 more

COMPLETED

Randomized Controlled Clinical Investigation Evaluating the Effect of Adipose Tissue Processed With the SyntrFuge™ System in the Healing of Diabetic Foot Ulcers

NCT05519501

Diabetic Foot Ulcer

COMPLETED NA

Treatment of Diabetic Foot Ulcers With Inforatio Technique to Promote Wound Healing

NCT03985306

Diabetic Foot Ulcer Diabetic Foot Wound Heal +2 more

COMPLETED NA

Biofilm Modified Macrophage Phenotype and Function in Diabetic Wound Healing

NCT03271580

Wound Bacterial Infections Diabetes Mellitus +1 more

TERMINATED

Effect of Meso Wound Matrix in the Treatment of DFUs

NCT04182451

Diabetic Foot Ulcers (DFUs)

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Diabetic Foot Ulcer

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

MIRODERM

Biologic wound graft

Intervention Type DEVICE

Diabetic foot ulcer will be treated by grafting with MIRODERM Biologic Wound Matrix

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Biologic wound graft

Diabetic foot ulcer will be treated by grafting with MIRODERM Biologic Wound Matrix

Intervention Type DEVICE

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

MIRODERM Biologic Wound Matrix treatment

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* 18 years old or older at time of initial visit
* Have Type I or Type II diabetes
* Have a neuropathic diabetic foot ulcer with the following characteristics:

* Is greater than 1 cm2 and less than or equal to 12 cm2
* Has failed to close following at least 2 treatments with a biologic
* Has been present for 90 days or longer
* Does not show signs of infection
* Is full thickness (Wagner Grade I or II)
* Located distal to the malleolus
* Depth of less than or equal to 5 mm
* No exposed capsule, tendon or bone
* No tunneling, undermining or sinus tracts
* Not between the toes
* Be willing and able to maintain required off-loading of affected limb
* Be willing and able to perform necessary dressing changes
* Have at least one of the following:

* An Ankle-brachial index (ABI) ≥ 0.8
* TcPO2 of ≥ 30 mmHg
* A toe pressure of ≥ 50 mmHg

Exclusion Criteria

* Be pregnant or be planning to become pregnant during the study
* Have had a Chopart's Amputation (or higher)
* Have a history of bone cancer of the affected limb
* Be undergoing dialysis
* Have active osteomyelitis or be receiving treatment for osteomyelitis
* Be diagnosed with unstable Charcot Foot on the affected side
* Have an HbA1c level of ≥ 12% within the past 90 days
* Have another ulcer within 2 cm of the study ulcer
* Be immunocompromised or at risk of immunosuppression as determined by the treating investigator
* Have a known collagen vascular disease or connective tissue disease
* Have received treatment of the study ulcer with a skin substitute product or topical growth factor within the past 4 weeks
* Be participating in another medical research study
* Have a sensitivity to porcine material

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No