Trial of Dehydrated Human Amnion/Chorion Membrane (dHACM) In the Management of Diabetic Foot Ulcers

September 21, 2018 updated by: MiMedx Group, Inc.

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
132

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35205
        • Central Research Associates, Inc.
    • California
      • Bakersfield, California, United States, 93309
        • Stockdale Podiatry Group
      • Castro Valley, California, United States, 94546
        • Center for Clinical Research INC
      • Fresno, California, United States, 93721
        • Limb Preservation Platform
      • Fresno, California, United States, 93720
        • Valley Vascular Surgery Associates
      • Indio, California, United States, 92201
        • Novak Urgent Care and Family Practice
      • Loma Linda, California, United States, 92357
        • Loma Linda VA Medical Center
      • Los Angeles, California, United States, 90057
        • Foot & Ankle Clinic
      • Palm Springs, California, United States, 92262
        • Palmtree Clinical Research, Inc.
      • Sacramento, California, United States, 95628
        • Center for Clinical Research, Inc.
      • San Francisco, California, United States, 94115
        • Center for Clinical Research
    • Massachusetts
      • Framingham, Massachusetts, United States, 01702
        • MetroWest Medical Center
      • Weymouth, Massachusetts, United States, 02190
        • South Shore Hospital
    • Ohio
      • Toledo, Ohio, United States, 43606
        • Jobst Vascular Institute, Promedica Toledo Hospital
    • Oregon
      • Eugene, Oregon, United States, 97401
        • Center for Clinical Research, Inc.
    • South Carolina
      • Columbia, South Carolina, United States, 29209
        • Dorn VA
    • Texas
      • McAllen, Texas, United States, 78501
        • Futuro Clinical Trials, LLC
    • Utah
      • Murray, Utah, United States, 84157
        • IMC Wound Care
      • Salt Lake City, Utah, United States, 84143
        • LDS Hospital
    • Virginia
      • Virginia Beach, Virginia, United States, 23464
        • Coastal Podiatry, Inc.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Male or female age 18 or older.
  2. The patient is willing and able to provide informed consent and participate in all procedures and follow up evaluations necessary to complete the study.
  3. Patient's ulcer must be diabetic in origin with a size ranging from 1 to 25 cm2. Debridement will be done prior to randomization, if clinically indicated.
  4. Wounds should be diabetic foot ulcers located on the dorsal or plantar surface of the foot.
  5. Patients with Type 1 or 2 diabetes (criteria for the diagnosis of diabetes mellitus per ADA).
  6. 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).
  7. Affected leg has been offloaded (removable walker or total contact cast) for >14 consecutive days prior to randomization.
  8. Serum Creatinine less than 3.0mg/dl (within last 6 months).
  9. HbA1c less than 12% within previous 60 days.

  10. Patient has adequate circulation to the affected extremity, as demonstrated by one of the following within the past 60 days:

    • Dorsum transcutaneous oxygen test (TcPO2) with results ≥30mmHg, OR
    • ABIs with results of ≥0.7 and ≤1.2, OR
    • Doppler arterial waveforms, which are triphasic or biphasic at the ankle of affected foot.
  11. Females of childbearing potential must be willing to use acceptable methods of contraception (birth control pills, barriers, or abstinence).

Exclusion Criteria:

  1. 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.
  2. Patients with multiple wounds on the same foot where other wounds are within 3 cm of the wound under care.
  3. Patients considered not in reasonable metabolic control, confirmed by an HbA1c 12% or greater at any time within previous 60 days.
  4. Known history of poor compliance with medical treatments.
  5. Patients currently enrolled in this study. Concurrent enrollment in the study is prohibited.
  6. Patients treated with investigational drug(s) or therapeutic device(s) within 30 days.
  7. Patients currently receiving radiation therapy or chemotherapy.
  8. Known or suspected local skin malignancy to the index diabetic ulcer.
  9. Patients diagnosed with autoimmune connective tissue diseases.
  10. Non-revascularizable surgical sites.
  11. Active infection at index site or currently being treated with antibiotics
  12. Any pathology that would limit the blood supply and compromise healing.
  13. Patients that have received a biomedical or topical growth factor for their wound within the previous 30 days. Study ulcer has been previously treated with tissue engineered materials (e.g. Apligraf® or Dermagraft®) or other scaffold materials (e.g. Oasis, Matristem) within the last 30 days.
  14. Patients who are known to be pregnant, plan to become pregnant, or are breast feeding.
  15. Known allergy to Gentamicin sulfate or Streptomycin sulfate.
  16. Active Charcot deformity or major structural abnormalities of the foot.
  17. Wounds that are greater than one year in duration without intermittent closure.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Other: Control
Standard of Care: Moist Wound Therapy and Offloading
Other: Standard of Care: Moist Wound Therapy and Offloading
Standard of Care: Moist Wound Therapy and Offloading
Experimental: EpiFix plus Standard of Care
Weekly application of EpiFix (up to 12 week) and standard of care (moist wound therapy and offloading)
Other: EpiFix plus Standard of Care
Weekly application of EpiFix and Standard of Care

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Percentage of subjects with complete closure of the study ulcer
Time Frame: Week 12
Assessed by the Investigator, during treatment (Visits 1 - 13).
Week 12

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Time to complete closure for both groups
Time Frame: Up to 12 Weeks
As assessed by photographic evaluation and the Investigator
Up to 12 Weeks
Rate of wound closure
Time Frame: Up to Week 12
As assessed by photographic evaluation and the Investigator
Up to Week 12
Incidence of ulcer recurrence
Time Frame: Up to Week 16
Incidence of ulcer recurrence at the site of the study ulcer during the follow up phase.
Up to Week 16
Quality of Life
Time Frame: Up to Week 12
Change in quality of life metrics as measured by SF-36 Health Survey and changes in the patient's reported pain scores as measured by the Visual Analog Scale.
Up to Week 12
Cost effectiveness of treatment
Time Frame: Up to Week 12
Cost effectiveness of treatment regimen.
Up to Week 12

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Safety
Time Frame: Up to Week 16
The Safety population will be used for the analysis of safety endpoints.
Up to Week 16

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
MiMedx Group, Inc.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: William Tettelbach, MD, Intermountain Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 1, 2012

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 1, 2018

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 1, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 19, 2012

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 21, 2012

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 26, 2012

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 24, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 21, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • EFDFU003

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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