A Multicenter, Prospective, Randomized, Controlled, Comparative Parallel Study of Dehydrated Human Amnion/Chorion Membrane (dHACM) Wound Graft in the Management of Diabetic Foot Ulcers

MiMedx Group, Inc.19 sites in 1 country132 target enrollmentJuly 2012

ConditionsDiabetic Foot Ulcer

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Diabetic Foot Ulcer
Sponsor: MiMedx Group, Inc.
Enrollment: 132
Locations: 19
Primary Endpoint: Percentage of subjects with complete closure of the study ulcer
Status: Completed
Last Updated: 7 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The objective of this study is to evaluate the percentage of patients with complete diabetic foot ulcer (DFU) closure following up to 12 weeks of treatment with either dehydrated human amnion/chorion membrane (dHACM) plus standard of care (SOC) or SOC alone.

Registry

clinicaltrials.gov

Start Date

July 2012

End Date

June 2018

Last Updated

7 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

MiMedx Group, Inc.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Male or female age 18 or older.
•The patient is willing and able to provide informed consent and participate in all procedures and follow up evaluations necessary to complete the study.
•Patient's ulcer must be diabetic in origin with a size ranging from 1 to 25 cm
•Debridement will be done prior to randomization, if clinically indicated.
•Wounds should be diabetic foot ulcers located on the dorsal or plantar surface of the foot.
•Patients with Type 1 or 2 diabetes (criteria for the diagnosis of diabetes mellitus per ADA).
•Ulcer must be present for a minimum of 30 days before enrollment/randomization, with documented failure of prior treatment to heal the wound (≤25% wound area reduction after 14 consecutive days of therapy immediately prior to randomization when treated with standard protocol of care).
•Affected leg has been offloaded (removable walker or total contact cast) for \>14 consecutive days prior to randomization.
•Serum Creatinine less than 3.0mg/dl (within last 6 months).
•HbA1c less than 12% within previous 60 days.

Exclusion Criteria

•Patients presenting with an ulcer probing to bone (UT Grade IIIA-D). A positive probe-tobone will be confirmed when bone or joint can be felt with a sterile, ophthalmological probe.
•Patients with multiple wounds on the same foot where other wounds are within 3 cm of the wound under care.
•Patients considered not in reasonable metabolic control, confirmed by an HbA1c 12% or greater at any time within previous 60 days.
•Known history of poor compliance with medical treatments.
•Patients currently enrolled in this study. Concurrent enrollment in the study is prohibited.
•Patients treated with investigational drug(s) or therapeutic device(s) within 30 days.
•Patients currently receiving radiation therapy or chemotherapy.
•Known or suspected local skin malignancy to the index diabetic ulcer.
•Patients diagnosed with autoimmune connective tissue diseases.
•Non-revascularizable surgical sites.